Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
235
Countries
12
Sites
29
Dermatomyositis
To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on Total Improvement Score (TIS) after 52 weeks in comparison to placebo
Key facts
- Sponsor
- Priovant Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 30 Nov 2022 → ongoing
- Decision date (initial)
- 2022-11-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Priovant Therapeutics, Inc. · Priovant Therapeutics, Inc.
External identifiers
- EU CT number
- 2022-500367-12-00
- ClinicalTrials.gov
- NCT05437263
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Dose response, Therapy, Pharmacokinetic, Efficacy
To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on Total Improvement Score (TIS) after 52 weeks in comparison to placebo
Secondary objectives 9
- To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score after 52 weeks in comparison to placebo
- To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on Dermatomyositis Outcomes for Muscle and Skin (DMOMS) after 52 weeks in comparison to placebo
- To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on TIS responder rate after 52 weeks in comparison to placebo
- To evaluate the onset of efficacy of brepocitinib for the treatment of dermatomyositis based on the time to achievement of ≥ 2 consecutive TIS ≥ 40 responses during 52 weeks in comparison to placebo
- To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on TIS response rate with no or low dose corticosteroids after 52 weeks in comparison to placebo
- To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on the CDASI Activity Score responder rate after 52 weeks in comparison to placebo
- To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on TIS responder rate after 52 weeks in comparison to placebo
- To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on the Health Assessment Questionnaire – Disability Index (HAQ-DI) after 52 weeks in comparison to placebo
- To evaluate early onset efficacy of brepocitinib for the treatment of dermatomyositis based on CDASI Activity Score after 4 weeks in comparison to placebo
Conditions and MedDRA coding
Dermatomyositis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012503 | Dermatomyositis | 100000004858 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male or female participant who must be ≥ 18 to =/< 75 years of age at the time of signing the informed consent form (ICF).
- Participants with a diagnosis of dermatomyositis according to the 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies.
- Active muscle and skin disease at screening and baseline
- Current therapy or past therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
- Participants with weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2
Exclusion criteria 7
- Dermatomyositis with end-stage organ involvement
- Dermatomyositis with irreversible muscle involvement
- History of any lymphoproliferative disorder; active malignancy; history of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.); cancer-associated dermatomyositis
- Overlap myositis/connective tissue disease (except for overlap with Secondary Sjögren's syndrome)
- Participants at a risk of thrombosis and cardiovascular disease
- Participants with a high risk for herpes zoster reactivation
- Participants with active or recent infections
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- TIS at Week 52 TIS is a composite endpoint based on the following six Disease Activity CSM scores and ranges from 0 to 100 (2016 ACR /EULAR Myositis Response Criteria): PhGA-VAS; PtGA-VAS; MMT8 ;HAQ Disability Index; Muscle Enzyme Assessment, EMGA-VAS
Secondary endpoints 9
- Change from baseline in CDASI Activity Score at Week 52
- DMOMS at Week 52 DMOMS is a composite endpoint based on the following four component measures and ranges from 0 to 100 [Pandya, 2024]: MMT-8; CDASI; PhGA-VAS; PtGA-VAS
- The proportion of participants achieving TIS ≥ 40 points (moderate improvement) at Week 52
- Time to achievement of consecutive (≥ 2 visits) TIS ≥ 40 points (moderate improvement) by Week 52
- The proportion of participants, regardless of baseline corticosteroid use, achieving TIS ≥ 40 points (moderate improvement) at Week 52 with 0 to ≤ 2.5 mg/day of oral prednisone (or equivalent) at both Week 48 and Week 52
- The proportion of participants achieving ≥ 40% improvement with a ≥ 4-point improvement from baseline in CDASI Activity Score at Week 52
- The proportion of participants achieving TIS ≥ 60 points (major improvement) at Week 52
- Change from baseline in HAQ-DI at Week 52
- Change from baseline in CDASI Activity score at Week 4
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9798839 · Product
- Active substance
- Brepocitinib Tosilate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 3120 mg milligram(s)
- Max treatment duration
- 114 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- PRIOVANT THERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9846394 · Product
- Active substance
- Brepocitinib Tosilate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 3120 mg milligram(s)
- Max treatment duration
- 114 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- PRIOVANT THERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
Placebo for brepocitinib 25 mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Priovant Therapeutics Inc.
- Sponsor organisation
- Priovant Therapeutics Inc.
- Address
- 151 West 42nd Street Floor 15
- City
- New York
- Postcode
- 10036-6509
- Country
- United States
Scientific contact point
- Organisation
- Priovant Therapeutics Inc.
- Contact name
- Scientific contact
Public contact point
- Organisation
- Priovant Therapeutics Inc.
- Contact name
- Scientific contact
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Other, Laboratory analysis |
| Kcas LLC ORG-100043073
|
Shawnee, United States | Other, Laboratory analysis |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Code 8 |
| CARDIABASE ORG-100043354
|
Nancy, France | Other |
| Elligo Health Research Inc. ORG-100044201
|
Austin, United States | Other |
| Premier Research Group S.L. ORG-100013963
|
Madrid, Spain | On site monitoring, Code 10, Code 12, Code 13, Other, Code 2, Interactive response technologies (IRT), Code 5, Data management, Code 8, Code 9 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Acm Medical Laboratory Inc. ORG-100042792
|
Rochester, United States | Other, Laboratory analysis |
| Catalent Germany Schorndorf GmbH ORG-100011845
|
Schorndorf, Germany | Code 14 |
Locations
12 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 4 | 1 |
| Bulgaria | Ongoing, recruitment ended | 12 | 5 |
| Czechia | Ended | 8 | 1 |
| Germany | Ongoing, recruitment ended | 12 | 3 |
| Hungary | Ongoing, recruitment ended | 7 | 3 |
| Italy | Ended | 15 | 3 |
| Netherlands | Ongoing, recruitment ended | 8 | 1 |
| Poland | Ended | 15 | 6 |
| Portugal | Ongoing, recruitment ended | 10 | 2 |
| Romania | Ended | 15 | 2 |
| Slovakia | 13 | 10 | 1 |
| Spain | Ended | 10 | 1 |
| Rest of world
United Kingdom, Turkey, Chile, Mexico, United States, Taiwan, Korea, Republic of, Canada
|
— | 109 | — |
Investigational sites
Medical Center Artmed Ltd.
N/A, Ulitsa Mladost 8, 4002, Plovdiv
Medical Center Excelsior OOD
NA, Lozenets, Ulitsa Golo Birdo 4, Sofiya
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Clinic of Rheumatology, Zapaden District, Sofia Str 64, Plovdiv
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Clinic of Rheumatology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Ambulatories For Specialized Outpatient Medical Help Medical Center Kyuchuk Parizh OOD
NA, Ulitsa Georgi Kondolov 43a, 4004, Plovdiv
Charite Universitatsmedizin Berlin KöR
Department of Dermatology, Charitéplatz 1, Mitte, Berlin
Medical Center - University Of Freiburg
Division of Rheumatology and Clinical Immunology, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Technische Universitat Dresden
Department of Dermatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Of Szeged
Bőrgyógyászati és Allergológiai Klinika, Koranyi Fasor 6, 6720, Szeged
University Of Debrecen
Belgyógyászati Intézet, Klinikai Immunológiai Tanszék, Moricz Zsigmond Korut 22, 4032, Debrecen
University Of Pecs
Reumatológiai és Immunológiai Klinika, Akac Utca 1, 7632, Pecs
University Hospital Consorziale Policlinico
Rheumatology, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Rheumatology, Corso Bramante 88, 10126, Turin
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Rheumatology, Largo Francesco Vito 1, 00168, Rome
Amsterdam UMC
Neurology, Meibergdreef 9, 1105 AZ, Amsterdam
Centrum Medyczne Plejady Sp. z o.o. S.K.
not applicable, U2 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
Reumed Sp. z o.o.
Filia nr 1 Wallenroda, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
not applicable, Ul. 1 Maja 38/39, 71-627, Szczecin
Klimed MK Sp. z o.o.
not applicable, Aleja Jana Pawla II 59/6u, 15-704, Bialystok
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
not applicable, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im. Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Rheuatology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital De Santa Maria E.P.E.
Rheuatology, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Spitalul Clinic Judetean De Urgenta Cluj
Rheumatology, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Saint Maria Hospital
Rheumatology, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Reum.Hapi s.r.o.
Rheumatology, Dukelska 10, 915 01, Nove Mesto Nad Vahom
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-02-23 | 2026-03-03 | 2023-12-07 | 2024-06-06 | |
| Bulgaria | 2022-11-30 | 2023-01-09 | 2024-06-06 | ||
| Czechia | 2022-12-12 | 2026-04-13 | 2023-01-04 | 2024-06-06 | |
| Germany | 2023-01-25 | 2023-05-25 | 2024-06-06 | ||
| Hungary | 2022-12-19 | 2023-02-09 | 2024-06-06 | ||
| Italy | 2022-12-23 | 2025-06-19 | 2023-03-07 | 2024-06-06 | |
| Netherlands | 2023-06-06 | 2023-09-12 | 2024-06-06 | ||
| Poland | 2022-12-02 | 2025-08-19 | 2022-12-20 | 2024-06-06 | |
| Portugal | 2023-09-13 | 2023-10-12 | 2024-06-06 | ||
| Romania | 2022-12-07 | 2026-02-23 | 2023-01-26 | 2024-06-06 | |
| Slovakia | 2022-11-30 | ||||
| Spain | 2023-01-18 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-106750
- Event date
- 2025-11-01
- Submission date
- 2025-11-20
- In response to
- OTHER
- Member states affected
- Bulgaria, Czechia, Germany, Hungary, Italy, Romania, Spain, Netherlands, Poland, Belgium, Portugal
- Event description
- The last working day of Dr. Enrico Fusaro - PI at site Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, SC Reumatologia, Corso Bramante, 88, 10126 Torino, Italy was 31Oct2025.
- Measures taken
- The new PI assigned is Dr. Simone Parisi, who has been a Sub-Investigator at the site. The PI change was implemented on 01Nov2025 in order the patients not to be left without supervision and care. The Sponsor/CRO were informed on 11Nov2025 by the site. This change will be submitted as a Substantial Modification once the ongoing SM review is complete. For this reason we are submitting this USM for the change of PI, as soon as possible after we were informed of it.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 437 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2022-500367-12-00_for Publication | 10.0 |
| Protocol (for publication) | D1_Protocol 2022-500367-12-00_Placebo justificaiton_Redacted | n.a. |
| Protocol (for publication) | D4 PROMIS SF Physical Function 8b ENG_Redacted | 2.0 |
| Protocol (for publication) | D4 PROMIS SF Physical Function 8b ROM_Redacted | 2.0 |
| Protocol (for publication) | D4_PROMIS SF Fatigue 7a ENG_Redacted | 1.0 |
| Protocol (for publication) | D4_PROMIS SF Fatigue 7a ROM_Redacted | 1.0 |
| Protocol (for publication) | D4_PROMIS SF Fatigue 7a_ENG_Redacted | 1 |
| Protocol (for publication) | D4_PROMIS SF Pain Interference 6a ENG_Redacted | 1.1 |
| Protocol (for publication) | D4_PROMIS SF Pain Interference 6a ROM_Redacted | 1.1 |
| Recruitment arrangements (for publication) | 39 PVT 2201 301 Magnet Contact Card Contact Information DEU DE | 1.0 |
| Recruitment arrangements (for publication) | 40 PVT 2201 301 Patient and Caregiver Travel Preference Form DEU DE | 1.0 |
| Recruitment arrangements (for publication) | 41 PVT 2201 301 Patient and Caregiver Meals and Incidentals Report DEU DE | 1.0 |
| Recruitment arrangements (for publication) | 42 PVT 2201 301 Patient Welcome Letter DEU DE | 1.0 |
| Recruitment arrangements (for publication) | 43 PVT 2201 301 RealTime Pay Instruction Guide DEU DE | 1.0 |
| Recruitment arrangements (for publication) | 44 PVT 2201 301 RealTime Pay Patient Portal Screenshots DEU fully translated | 1.0 |
| Recruitment arrangements (for publication) | 45 PVT 2201 301 Travel and Reimbursement Program FAQ DEU DE | 1.0 |
| Recruitment arrangements (for publication) | 64 The VALOR Study Thank You Card English layout | 1.0 |
| Recruitment arrangements (for publication) | 64 The VALOR Study Thank You Card German text | 1.0 |
| Recruitment arrangements (for publication) | Direct Deposit FAQ | 1.0 |
| Recruitment arrangements (for publication) | Direct Deposit FAQ OUS | 1 |
| Recruitment arrangements (for publication) | Direct Deposit FAQ ROM | 1 |
| Recruitment arrangements (for publication) | German PVT 2201 301 PatientWalletCard | 1.0 |
| Recruitment arrangements (for publication) | K1_GP Letter_ BGR_Redacted | 5.0 |
| Recruitment arrangements (for publication) | K1_GP Letter_HUN_redacted | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZE | 1.0 |
| Recruitment arrangements (for publication) | K1_Travel Consent Form_ROU_English | 2 |
| Recruitment arrangements (for publication) | K1_Travel Consent Form_ROU_Romanian | 2 |
| Recruitment arrangements (for publication) | K2 Thank You Card | 1.0 |
| Recruitment arrangements (for publication) | K2_GP letter_CZE_Redacted | 5.0 |
| Recruitment arrangements (for publication) | K2_GP Letter_ROU_English_Redacted | 5.0 |
| Recruitment arrangements (for publication) | K2_GP Letter_ROU_Romanian_Redacted | 5.0 |
| Recruitment arrangements (for publication) | K2_Patient Tote Bag | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Tote Bag | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Tote Bag_CZE | 2.0 |
| Recruitment arrangements (for publication) | K2_VALOR Thank You Card_CZE | 1 |
| Recruitment arrangements (for publication) | L1_SIS and ICF_Travel Consent Form_DEU_clean | 2.0 |
| Recruitment arrangements (for publication) | Magnet Contact Card Contact Information | 2.0 |
| Recruitment arrangements (for publication) | Magnet Contact Card Contact Information OUS | 1 |
| Recruitment arrangements (for publication) | Magnet Contact Card Contact Information ROM | 1 |
| Recruitment arrangements (for publication) | Patient and Caregiver Meals and Incidentals Report | 1.0 |
| Recruitment arrangements (for publication) | Patient and Caregiver Meals and Incidentals Report OUS | 1 |
| Recruitment arrangements (for publication) | Patient and Caregiver Meals and Incidentals Report ROM | 1 |
| Recruitment arrangements (for publication) | Patient and Caregiver Travel Preference Form | 2.0 |
| Recruitment arrangements (for publication) | Patient and Caregiver Travel Preference Form OUS | 1 |
| Recruitment arrangements (for publication) | Patient and Caregiver Travel Preference Form ROM | 1 |
| Recruitment arrangements (for publication) | Patient Thank You Card | 1 |
| Recruitment arrangements (for publication) | Patient Thank You Card | 1.0 |
| Recruitment arrangements (for publication) | Patient Tote Bag | n.a |
| Recruitment arrangements (for publication) | Patient Tote Bag ENG | NA |
| Recruitment arrangements (for publication) | Patient Tote Bag ROM | NA |
| Recruitment arrangements (for publication) | Patient Wallet Card | 1 |
| Recruitment arrangements (for publication) | Patient Wallet Card | 1 |
| Recruitment arrangements (for publication) | Patient Wallet Card | 1 |
| Recruitment arrangements (for publication) | Patient Wallet Card ENG | 1 |
| Recruitment arrangements (for publication) | Patient Wallet Card ROM | 1 |
| Recruitment arrangements (for publication) | Priovant Therapeutics_The VALOR Study_PL_ThankYouCard | 1 |
| Recruitment arrangements (for publication) | PVT 2201 301 Direct Deposit FAQ DEU DE | 1.0 |
| Recruitment arrangements (for publication) | RealTime Pay Instruction Guide | 2.0 |
| Recruitment arrangements (for publication) | RealTime Pay Instruction Guide OUS | 1 |
| Recruitment arrangements (for publication) | RealTime Pay Instruction Guide ROM | 1 |
| Recruitment arrangements (for publication) | RealTime Pay Patient Portal Screenshots | 1.0 |
| Recruitment arrangements (for publication) | RealTime Pay Patient Portal Screenshots OUS V1 | 1.0 |
| Recruitment arrangements (for publication) | RealTime Pay Patient Portal Screenshots ROM V1 | 1 |
| Recruitment arrangements (for publication) | RealTime Pay Patient Portal Screenshots ROM V2 | 2 |
| Recruitment arrangements (for publication) | Thank You Card | 0.3 |
| Recruitment arrangements (for publication) | Thank You Card ENG | 1 |
| Recruitment arrangements (for publication) | Thank You Card ROM | 1 |
| Recruitment arrangements (for publication) | Travel and Reimbursement Program FAQ | 2.0 |
| Recruitment arrangements (for publication) | Travel and Reimbursement Program FAQ OUS | 1 |
| Recruitment arrangements (for publication) | Travel and Reimbursement Program FAQ ROM | 1 |
| Recruitment arrangements (for publication) | Travel Consent Form | 2.0 |
| Subject information and informed consent form (for publication) | 12_PVT 2201 301 DM PrivacyPolicy Germany | 1.0 |
| Subject information and informed consent form (for publication) | 47 FACIT FatigueScale GER Final Header Redacted for publishing | NA |
| Subject information and informed consent form (for publication) | 48 HAQ DI Header Redacted for publishing | AU1.0 |
| Subject information and informed consent form (for publication) | 49 PtGA Flexibility PATIENT German DEU | NA |
| Subject information and informed consent form (for publication) | 50 PtGA Muscle PATIENT German DEU | NA |
| Subject information and informed consent form (for publication) | 51 PtGA Pain PATIENT German DEU | NA |
| Subject information and informed consent form (for publication) | 52 PtGI Severity PATIENT German DEU | NA |
| Subject information and informed consent form (for publication) | 53 PtGA Skin PATIENT German DEU | NA |
| Subject information and informed consent form (for publication) | 54 PtGA Swallow PATIENT German DEU | NA |
| Subject information and informed consent form (for publication) | 55 PtGA VAS GlobalDisease ENG PATIENT German DEU Redacted for publishing | NA |
| Subject information and informed consent form (for publication) | 56 PtGI C PATIENT German DEU | NA |
| Subject information and informed consent form (for publication) | 57 Skindex16 deu DE Header Redacted for publishing | AU2.1 |
| Subject information and informed consent form (for publication) | 58 PP-NRS deu DE Header Redacted for publishing | 1.0 |
| Subject information and informed consent form (for publication) | 59 SF 36v2 standard deu DE header Redacted for publishing | NA |
| Subject information and informed consent form (for publication) | Bulgarian Pregnant Participant ICF for Bulgaria | 1 |
| Subject information and informed consent form (for publication) | Bulgarian Pregnant Partner ICF for Bulgaria | 1 |
| Subject information and informed consent form (for publication) | Direct Deposit FAQ | 1.0 |
| Subject information and informed consent form (for publication) | Direct Deposit FAQ_ENG | 1 |
| Subject information and informed consent form (for publication) | Direct Deposit FAQ_POL | 1 |
| Subject information and informed consent form (for publication) | Document list | NA |
| Subject information and informed consent form (for publication) | FACIT DU_Redacted | n.a |
| Subject information and informed consent form (for publication) | FACIT Fatigue Scale ENG Redacted | 4 |
| Subject information and informed consent form (for publication) | FACIT Fatigue Scale Redacted | 4 |
| Subject information and informed consent form (for publication) | FACIT Fatigue Scale ROM Redacted | 4 |
| Subject information and informed consent form (for publication) | FACIT Fatigue Scale_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | FACIT FatigueScale_Redacted | NA |
| Subject information and informed consent form (for publication) | FACIT FRE Redacted | n.a |
| Subject information and informed consent form (for publication) | FACIT GER Redacted | n.a |
| Subject information and informed consent form (for publication) | FACIT-FatigueScale_ENG_PATIENT_Redacted | n.a |
| Subject information and informed consent form (for publication) | HAQ DI AU_Redacted | N/A |
| Subject information and informed consent form (for publication) | HAQ DI Redacted | 1 |
| Subject information and informed consent form (for publication) | HAQ DI_Redacted | NA |
| Subject information and informed consent form (for publication) | HAQ Health Assessment Questionnaire ENG Redacted | 1 |
| Subject information and informed consent form (for publication) | HAQ Health Assessment Questionnaire ROM Redacted | 1 |
| Subject information and informed consent form (for publication) | HAQ_deu_Redacted | 2 |
| Subject information and informed consent form (for publication) | HAQ_dutch Redacted | 2 |
| Subject information and informed consent form (for publication) | HAQ_eng Redacted | 2 |
| Subject information and informed consent form (for publication) | HAQfra_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_GER_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_Bulgaria Main ICF_Bulgarian_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_ICF main BEL_Dutch_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_ICF_main_BEL_English_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_ICF_main_BEL_French_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_ICF_main_BEL_German_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_HUN_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_ICF_main_Italy_Italian_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF_main_NLD_Dutch_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_ICF_main_Poland_Polish_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Participant _BEL_Dutch | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Participant _BEL_French | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant participant_ Italy_Italian | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Participant_BEL_English | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Participant_BEL_German | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Participant_NLD_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant partner_BEL_Dutch | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant partner_BEL_English | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant partner_BEL_French | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant partner_BEL_German | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant partner_Italy_Italian | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner_NLD_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner_Poland_Polish | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Travel Consent Form for Bulgaria_English | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF-Main_POR_Portuguese_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_ICF-Pregnant-Participant_POR_Portuguese | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF-Pregnant-Partner_POR_Portuguese | 2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF for Bulgaria_English_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_ROM_Romanian_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_ROU_English_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Participant ICF_ROM_English | 4.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Participant ICF_ROM_Romanian | 4.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_ROM_English | 4.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_ROM_Romanian | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Samples_CZE | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR ICF_CZE | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR ICF_CZE_Highlighted_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZE_Highlighted_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZE_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_CZE | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_GER_clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZE | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_GER_clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_Dutch | 3 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_Dutch_TC | 3 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_English | 3 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_English_TC | 3 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_French | 3 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_French_TC | 3 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_German | 3 |
| Subject information and informed consent form (for publication) | L1_Travel consent form_BEL_German_TC | 1 |
| Subject information and informed consent form (for publication) | L1_Travel Consent Form_Poland_Polish | 2 |
| Subject information and informed consent form (for publication) | L1_Travel Consent Form_POR _Portuguese | 3 |
| Subject information and informed consent form (for publication) | L1_Travel Only Consent Form for Bulgaria_Bulgarian | 3.0 |
| Subject information and informed consent form (for publication) | L2 Direct Deposit FAQ | 1.0 |
| Subject information and informed consent form (for publication) | L2 DM PrivacyPolicy | 1.0 |
| Subject information and informed consent form (for publication) | L2 Magnet Contact Card Contact Information | 1.0 |
| Subject information and informed consent form (for publication) | L2 Patient and Caregiver Meals and Incidentals Report | 1.0 |
| Subject information and informed consent form (for publication) | L2 Patient and Caregiver Travel Preference Form | 1.0 |
| Subject information and informed consent form (for publication) | L2 Patient Tote bag | N/A |
| Subject information and informed consent form (for publication) | L2 Patient Wallet card | 1.0 |
| Subject information and informed consent form (for publication) | L2 RealTime Pay Instruction Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2 RealTime Pay Patient Portal Screenshots | 2.0 |
| Subject information and informed consent form (for publication) | L2 Travel and Reimbursement Program FAQ | 1.0 |
| Subject information and informed consent form (for publication) | L2 Travel Consent Form | 1.0 |
| Subject information and informed consent form (for publication) | L2_ICF_Travel_HUN | 3.0 |
| Subject information and informed consent form (for publication) | L2_Magnet-Contact-Card-Contact-Information | 1 |
| Subject information and informed consent form (for publication) | L2_Newsletter_Belgium_Dutch | 1 |
| Subject information and informed consent form (for publication) | L2_Newsletter_Belgium_English | 1 |
| Subject information and informed consent form (for publication) | L2_Newsletter_Belgium_French | 1 |
| Subject information and informed consent form (for publication) | L2_Newsletter_Belgium_German | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Direct Deposit FAQ_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACIT-FatigueScale_CZE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HAQ-DI_CZE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Magnet Contact Card Contact Information_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient and Caregiver Meals and Incidentals Report_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient and Caregiver Travel Preference Form_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient tote Bag | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PP-NRS_CZE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PROMIS Fatigue 7a_CZE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PROMIS Pain Interference 6a_CZE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PROMIS Physical Function 8b_CZE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGA-Flexibility_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGA-Muscle_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGA-Pain_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGA-Skin_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGA-Swallow_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGA-VAS GlobalDisease_CZE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGI-C_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PtGI-Severity_CZE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RealTime-Pay Instruction Guide_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RealTime-Pay Patient Portal Screenshots_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SF 36_CZE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Skindex16_CZE_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Travel and Reimbursement Program FAQ_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Travel consent form_CZE | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VALOR Patient Wallet Card_CZE | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Caregiver Travel Preference Form_clean | 1 |
| Subject information and informed consent form (for publication) | L2_Patient tote Bag | 2 |
| Subject information and informed consent form (for publication) | L2_PatientToteBag | 2 |
| Subject information and informed consent form (for publication) | L2_Questionnaire_FACIT FatigueScale_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_HAQ DI_AU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PPNRS_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PROMIS_Fatigue7a_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PROMIS_PainInterference6a_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PROMIS_PhysicalFunction8b_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGAFlexibility_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGAMuscle_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGAPain_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGASkin_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGASwallow_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGAVASGlobalDisease_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGI C_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_PtGI Severity_Redacted | n.a |
| Subject information and informed consent form (for publication) | L2_Questionnaire_SF36Standard_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Questionnaire_Skindex16_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L2_ROM Newsletter ENG | 1 |
| Subject information and informed consent form (for publication) | L2_ROM Newsletter ROM | 1 |
| Subject information and informed consent form (for publication) | L2_ROM Patient Tote Bag ENG | 2.0 |
| Subject information and informed consent form (for publication) | L2_ROM Patient Tote Bag ROM | 2.0 |
| Subject information and informed consent form (for publication) | L2_ThankYouCard | 1.0 |
| Subject information and informed consent form (for publication) | L2_Travel Reimbursement Program FAQ | 2 |
| Subject information and informed consent form (for publication) | L2_WalletCard | 1.0 |
| Subject information and informed consent form (for publication) | L3_ICF_Pregnant Participant_HUN | 3.0 |
| Subject information and informed consent form (for publication) | L3_ICF_Pregnant Partner_HUN | 3.0 |
| Subject information and informed consent form (for publication) | Magnet Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | Magnet Contact Card Contact Information ENG | 1 |
| Subject information and informed consent form (for publication) | MagnetContactCard ContactInformation_POL | 1 |
| Subject information and informed consent form (for publication) | Meals and Incidentals Report | 1.0 |
| Subject information and informed consent form (for publication) | Paient and Caregiver Travel Preference Form ENG | 1 |
| Subject information and informed consent form (for publication) | Patient and Caregiver Meals and Incidentals Report ENG | 1 |
| Subject information and informed consent form (for publication) | Patient and CaregiverMeals and IncidentalsReport_POL | 1 |
| Subject information and informed consent form (for publication) | Patient and CaregiverTravel PreferenceForm_POL | 1 |
| Subject information and informed consent form (for publication) | Patient Tote Bag_de | n.a |
| Subject information and informed consent form (for publication) | Patient Tote bag_dut | n.a |
| Subject information and informed consent form (for publication) | Patient Tote Bag_eng | NA |
| Subject information and informed consent form (for publication) | Patient Tote Bag_fre | n.a |
| Subject information and informed consent form (for publication) | Patient Wallet Card_de | 1.0 |
| Subject information and informed consent form (for publication) | Patient Welcome Letter ENG | 1 |
| Subject information and informed consent form (for publication) | PatientCaregiver Travel Pref Form | 1.0 |
| Subject information and informed consent form (for publication) | PatientWallet card_du | 1.0 |
| Subject information and informed consent form (for publication) | PatientWalletCard_eng | 1 |
| Subject information and informed consent form (for publication) | PatientWalletCard_fre | 1.0 |
| Subject information and informed consent form (for publication) | Polish_PVT_2201_301_PL_PregnantParticipantICF | 1 |
| Subject information and informed consent form (for publication) | PP NRS Redacted | 1 |
| Subject information and informed consent form (for publication) | PP NRS_Redacted | 1 |
| Subject information and informed consent form (for publication) | PP-NRS Pruritus Itch NRS ENG Redacted | 1 |
| Subject information and informed consent form (for publication) | PP-NRS Pruritus Itch NRS ROM Redacted | 1 |
| Subject information and informed consent form (for publication) | PP-NRS_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PPNRS dut_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PPNRS fra_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PPNRS_de_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PPNRSeng_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Participant ICF for Bulgaria | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner ICF for Bulgaria | 1.0 |
| Subject information and informed consent form (for publication) | Privacy Policy | 1.0 |
| Subject information and informed consent form (for publication) | PROMIS SF Fatigue 7a ENG Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PROMIS SF Fatigue 7a Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF Fatigue 7a ROM Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PROMIS SF Fatigue 7a_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PROMIS SF Pain Interference 6a ENG Redacted | 1.1 |
| Subject information and informed consent form (for publication) | PROMIS SF Pain Interference 6a Redacted | 1.1 |
| Subject information and informed consent form (for publication) | PROMIS SF Pain Interference 6a ROM Redacted | 1.1 |
| Subject information and informed consent form (for publication) | PROMIS SF Pain Interference 6a_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | PROMIS SF Physical Function 8b ENG Redacted | 2.0 |
| Subject information and informed consent form (for publication) | PROMIS SF Physical Function 8b Redacted | 2 |
| Subject information and informed consent form (for publication) | PROMIS SF Physical Function 8b ROM Redacted | 2 |
| Subject information and informed consent form (for publication) | PROMIS SF Physical Function 8b_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 - Fatigue 7a_ITA_13Feb2020_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 1 - Pain Interference 6a_ITA_7Jul2020_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Fatigue 7a DUT 29Apr2019 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Fatigue 7a ENG 31Jul2018 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Fatigue 7a FRE 30Jan2018 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Fatigue 7a GER 30Jan2018_Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Pain Interference 6a DUT 24Jun2020 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Pain Interference 6a ENG 05Jun2020 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Pain Interference 6a FRE 26Jun2020 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v1 Pain Interference 6a GER 26Jun2020 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v2 Physical Function 8b DUT 06Jan2018 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v2 Physical Function 8b ENG 16Nov2022 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v2 Physical Function 8b FRE 24Apr2019 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v2 Physical Function 8b GER 3Jul2019 Redacted | 1 |
| Subject information and informed consent form (for publication) | PROMIS SF v2 Physical Function 8b_ITA_24Apr2019_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | PtGA Flexibility | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Flexibility | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Flexibility | N/A |
| Subject information and informed consent form (for publication) | PtGA Flexibility ROM | NA |
| Subject information and informed consent form (for publication) | PtGA Muscle | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Muscle | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Muscle | N/A |
| Subject information and informed consent form (for publication) | PtGA Muscle ENG | NA |
| Subject information and informed consent form (for publication) | PtGA Muscle ROM | NA |
| Subject information and informed consent form (for publication) | PtGA Pain | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Pain | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Pain | N/A |
| Subject information and informed consent form (for publication) | PtGA Pain ENG | NA |
| Subject information and informed consent form (for publication) | PtGA Pain ROM | NA |
| Subject information and informed consent form (for publication) | PtGA Severity | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Skin | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Skin | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Skin | N/A |
| Subject information and informed consent form (for publication) | PtGA Skin ENG | NA |
| Subject information and informed consent form (for publication) | PtGA Skin ROM | NA |
| Subject information and informed consent form (for publication) | PtGA Swallow | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Swallow | 1.0 |
| Subject information and informed consent form (for publication) | PtGA Swallow | N/A |
| Subject information and informed consent form (for publication) | PtGA Swallow ENG | NA |
| Subject information and informed consent form (for publication) | PtGA Swallow ROM | NA |
| Subject information and informed consent form (for publication) | PtGA VAS Global Disease Redacted | NA |
| Subject information and informed consent form (for publication) | PtGA VAS Global Disease_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PtGA VAS GlobalDisease ENG Redacted | NA |
| Subject information and informed consent form (for publication) | PtGA VAS GlobalDisease ROM Redacted | NA |
| Subject information and informed consent form (for publication) | PtGA VAS GlobalDisease_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PtGA-Flexibility_03Mar2022_PATIENT_Dutch_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Flexibility_03Mar2022_PATIENT_French_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Flexibility_ENG_03Mar2022_PATIENT | na |
| Subject information and informed consent form (for publication) | PtGA-Flexibility_ENG_03Mar2022_PATIENT_German_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Muscle_03Mar2022_PATIENT_Dutch_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Muscle_03Mar2022_PATIENT_French_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Muscle_ENG_03Mar2022_PATIENT | na |
| Subject information and informed consent form (for publication) | PtGA-Muscle_ENG_03Mar2022_PATIENT_German_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Pain_03Mar2022_PATIENT_Dutch_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Pain_03Mar2022_PATIENT_French_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Pain_ENG_03Mar2022_PATIENT | na |
| Subject information and informed consent form (for publication) | PtGA-Pain_ENG_03Mar2022_PATIENT_German_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Severity_03Mar2022_PATIENT_Dutch_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Severity_03Mar2022_PATIENT_French_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Severity_ENG_03Mar2022_PATIENT | na |
| Subject information and informed consent form (for publication) | PtGA-Severity_ENG_03Mar2022_PATIENT_German_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Skin_03Mar2022_PATIENT_Dutch_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Skin_03Mar2022_PATIENT_French_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Skin_ENG_03Mar2022_PATIENT | na |
| Subject information and informed consent form (for publication) | PtGA-Skin_ENG_03Mar2022_PATIENT_German_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Swallow_03Mar2022_PATIENT_Dutch_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Swallow_03Mar2022_PATIENT_French_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGA-Swallow_ENG_03Mar2022_PATIENT | na |
| Subject information and informed consent form (for publication) | PtGA-Swallow_ENG_03Mar2022_PATIENT_German_BEL_20220617 | NA |
| Subject information and informed consent form (for publication) | PtGA-VAS GlobalDisease_ENG_PATIENT_French_BEL_20220617_Redacted | n.a |
| Subject information and informed consent form (for publication) | PtGA-VAS GlobalDisease_ENG_PATIENT_German_BEL_20220617_Redacted | n.a |
| Subject information and informed consent form (for publication) | PtGA-VAS GlobalDisease_ENG_PATIENT_Redacted | n.a |
| Subject information and informed consent form (for publication) | PtGA-VAS GlobalDisease_PATIENT_Dutch_BEL_20220617_Redacted | n.a |
| Subject information and informed consent form (for publication) | PtGI C | 1.0 |
| Subject information and informed consent form (for publication) | PtGI C | 1.0 |
| Subject information and informed consent form (for publication) | PtGI C | N/A |
| Subject information and informed consent form (for publication) | PtGI C Patient Global Impression Change ENG | NA |
| Subject information and informed consent form (for publication) | PtGI C Patient Global Impression Change ROM | NA |
| Subject information and informed consent form (for publication) | PtGI Severity | 1.0 |
| Subject information and informed consent form (for publication) | PtGI Severity | N/A |
| Subject information and informed consent form (for publication) | PtGI Severity ENG | NA |
| Subject information and informed consent form (for publication) | PtGI Severity ROM | NA |
| Subject information and informed consent form (for publication) | PtGI-C_03Mar2022 | na |
| Subject information and informed consent form (for publication) | PtGI-C_03Mar2022_PATIENT_Dutch_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGI-C_03Mar2022_PATIENT_French_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PtGI-C_03Mar2022_PATIENT_German_BEL_20220617 | na |
| Subject information and informed consent form (for publication) | PVT-2201-301 PROMIS SF v1 Fatigue 7a BUL 16Oct2017 Redacted | 1.0 |
| Subject information and informed consent form (for publication) | PVT-2201-301 PROMIS SF v1_1 Pain Interference 6a BUL 24Jun2020 Redacted | 1.1 |
| Subject information and informed consent form (for publication) | PVT-2201-301 PROMIS SF v2 Physical Function 8b BUL 10May2019 Redacted | 2.0 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Direct Deposit FAQ_BEL_V1_FR-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Direct Deposit FAQ_BEL_V1_NL-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Direct Deposit FAQ_DEU_V1_DE-DE | 1.0 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Magnet Contact Card Contact Information_BEL_V1_FR-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Magnet Contact Card Contact Information_BEL_V1_NL-BE | 1.0 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Magnet Contact Card Contact Information_DEU_V1_DE-DE | 1.0 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Paient and Caregiver Travel Preference Form_BEL_1_FR-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Paient and Caregiver Travel Preference Form_BEL_1_NL-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Patient and Caregiver Meals and Incidentals Report_BEL_V1_FR-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Patient and Caregiver Meals and Incidentals Report_BEL_V1_NL-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Patient and Caregiver Meals and Incidentals Report_DEU_V1_DE-DE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Patient and Caregiver Travel Preference Form_DEU_1_DE-DE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Patient Welcome Letter_BEL_V1_FR-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Patient Welcome Letter_BEL_V1_NL-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Patient Welcome Letter_DEU_V1_DE-DE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_RealTime-Pay Instruction Guide_BEL_V1_FR-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_RealTime-Pay Instruction Guide_BEL_V1_NL-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_RealTime-Pay Instruction Guide_DEU_V1_DE-DE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_RealTime-Pay Patient Portal Screenshots_BEL_Dutch_V1-- fully translated | 2 |
| Subject information and informed consent form (for publication) | PVT-2201-301_RealTime-Pay Patient Portal Screenshots_BEL_French Full translated | 2 |
| Subject information and informed consent form (for publication) | PVT-2201-301_RealTime-Pay Patient Portal Screenshots_DEU_V1 fully translated | 2 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Travel and Reimbursement Program FAQ_BEL_V1_FR-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Travel and Reimbursement Program FAQ_BEL_V1_NL-BE | 1 |
| Subject information and informed consent form (for publication) | PVT-2201-301_Travel and Reimbursement Program FAQ_DEU_V1_DE-DE | 1 |
| Subject information and informed consent form (for publication) | RealTime_Pay Patient Portal Screenshots_POL | 1 |
| Subject information and informed consent form (for publication) | RealTime-Pay Instruction Guide ENG | 1 |
| Subject information and informed consent form (for publication) | RealTime-Pay Instruction Guide_POL | 1 |
| Subject information and informed consent form (for publication) | RealTime-Pay Patient Portal Screenshots ENG | 2 |
| Subject information and informed consent form (for publication) | RealTimePay Instruction Guide | 1.0 |
| Subject information and informed consent form (for publication) | RTP Patient Portal Screenshots | 1.0 |
| Subject information and informed consent form (for publication) | SF 36 de_Redacted | 2 |
| Subject information and informed consent form (for publication) | SF 36 eng_Redacted | 2 |
| Subject information and informed consent form (for publication) | SF 36 fr_Redacted | 2 |
| Subject information and informed consent form (for publication) | SF 36 Redacted | 2 |
| Subject information and informed consent form (for publication) | SF 36_dut_Redacted | 2 |
| Subject information and informed consent form (for publication) | SF 36_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | SF 36_Redacted | n.a |
| Subject information and informed consent form (for publication) | SF-36 v2 ENG Your Health and Well Being Redacted | 2 |
| Subject information and informed consent form (for publication) | SF-36 v2 Your Health and Well Being ROM Redacted | 2 |
| Subject information and informed consent form (for publication) | Skindex16 Dermatology Survey ENG Redacted | NA |
| Subject information and informed consent form (for publication) | Skindex16 Dermatology Survey ROM Redacted | NA |
| Subject information and informed consent form (for publication) | Skindex16 dut_Redacted | n.a |
| Subject information and informed consent form (for publication) | Skindex16 eng_Redacted | n.a |
| Subject information and informed consent form (for publication) | Skindex16 fra_Redacted | n.a |
| Subject information and informed consent form (for publication) | Skindex16 Redacted | NA |
| Subject information and informed consent form (for publication) | Skindex16_de_Redacted | n.a |
| Subject information and informed consent form (for publication) | Skindex16_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | Skindex16_Redacted | NA |
| Subject information and informed consent form (for publication) | Travel and Reimbursement Program FAQ | 1.0 |
| Subject information and informed consent form (for publication) | Travel and Reimbursement Program FAQ ENG | 1 |
| Subject information and informed consent form (for publication) | Travel and Reimbursement Program FAQ_POL | 1 |
| Subject information and informed consent form (for publication) | VALOR Study Thank You Card v1 18Mar202Dutch | 1.0 |
| Subject information and informed consent form (for publication) | VALOR Study Thank You Card v1 18Mar202English | 1.0 |
| Subject information and informed consent form (for publication) | VALOR Study Thank You Card v1 18Mar202French | 1.0 |
| Subject information and informed consent form (for publication) | VALOR Study Thank You Card v1 18Mar202German | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2022-500367-12-00 English | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2022-500367-12-00 English_Redacted | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Bel 2022-500367-12-00 Dutch | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Bel 2022-500367-12-00 French | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Bel 2022-500367-12-00 German | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BGR 2022-500367-12-00 Bulgarian | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZE 2022-500367-12-00_Czech | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis GER 2022-500367-12-00 German | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis HUN 2022-500367-12-00_Hungarian | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ITA 2022-500367-12-00 Italian | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NLD 2022-500367-12-00 Dutch | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis POL 2022-500367-12-00 Polish | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ROU 2022-500367-12-00 Romanian | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_POR_2022-500367-12-00_Portuguese | 10.0 |
Application history
25 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-17 | Poland | Acceptable 2022-11-07
|
2022-11-08 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2022-11-25 | Acceptable 2022-11-07
|
2022-11-29 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-02-10 | Poland | Acceptable 2023-05-15
|
2023-05-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-05-23 | Acceptable 2023-05-15
|
2023-05-23 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2023-05-24 | 2023-08-07 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-06-15 | Acceptable | 2023-07-26 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-06-15 | Acceptable | 2023-08-24 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-06-20 | Acceptable | 2023-08-04 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-11 | 2023-06-21 | Acceptable | 2023-07-26 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-13 | 2023-06-21 | Acceptable | 2023-07-20 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2023-06-22 | Acceptable | 2023-08-07 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-12 | 2023-06-22 | Acceptable | 2023-08-08 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-06-23 | Poland | Acceptable | 2023-08-28 |
| 14 | SUBSTANTIAL MODIFICATION | SM-14 | 2023-09-08 | Poland | Acceptable 2023-11-09
|
2023-11-09 |
| 15 | SUBSTANTIAL MODIFICATION | SM-21 | 2024-03-13 | Poland | Acceptable 2024-06-17
|
2024-06-17 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-07-09 | |||
| 17 | SUBSTANTIAL MODIFICATION | SM-23 | 2024-11-21 | Acceptable | 2024-12-19 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-12-19 | Poland | 2024-12-19 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-01-07 | Poland | 2025-01-07 | |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-04-07 | Poland | 2025-04-07 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-25 | 2025-04-15 | Poland | Acceptable 2025-07-21
|
2025-07-21 |
| 22 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-09-01 | Poland | Acceptable 2025-07-21
|
2025-09-01 |
| 23 | SUBSTANTIAL MODIFICATION | SM-26 | 2025-09-03 | Poland | Acceptable 2025-11-21
|
2025-11-21 |
| 24 | SUBSTANTIAL MODIFICATION | SM-27 | 2026-01-23 | Acceptable | 2026-03-10 | |
| 25 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2026-03-12 | Poland | 2026-03-12 |