Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
240
Countries
19
Sites
63
Active Idiopathic Inflammatory Myopathy (IIM)
To assess the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM
Key facts
- Sponsor
- Argenx
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 20 Sep 2023 → ongoing
- Decision date (initial)
- 2023-09-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- argenx BV
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Safety
To assess the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM
Secondary objectives 2
- To assess the health impact of glucocorticoid use and evaluate the steroid-sparing effect of efgartigimod PH20 SC
- To observe the long-term efficacy of efgartigimod PH20 SC
Conditions and MedDRA coding
Active Idiopathic Inflammatory Myopathy (IIM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10028395 | Musculoskeletal and connective tissue disorders | 17 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Open-label Extension of Study ARGX-113-2007 In the ARGX-113-2011 Open-Label Extension study (OLE), a treatment period of up to 51 months has been planned. This will allow for further safety and efficacy data to be collected over this extended period.
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2021-001277-23 | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy , Et fase 2/3, randomiseret, dobbeltblindet, placebokontrolleret, parallelgruppe-, dobbeltarmet, operationelt harmonisk multicenterforsøg til evaluering af effektivitet, sikkerhed, tolerabilitet, farmakodynamik, farmakokinetik og immunogenicitet ved Efgartigimod PH20 SC hos deltagere, der er mindst 18 år og har aktiv, idiopatisk, inflammatorisk myopati, Estudio en fase II/III, aleatorizado, con enmascaramiento doble, comparativo con placebo, con grupos paralelos, de 2 grupos, multicéntrico y sin interrupciones operativas para evaluar la eficacia, la seguridad, la tolerabilidad, la farmacodinámica, la farmacocinética y la inmunogenicidad de efgartigimod PH20 s.c. en participantes de 18 años o más con miopatía inflamatoria idiopática activa, Randomizovaná, dvojitě zaslepená, placebem kontrolovaná multicentrická studie fáze 2/3 s nepřerušovaným přechodem mezi fázemi, se dvěma paralelními rameny pro vyhodnocení účinnosti, bezpečnosti, snášenlivosti, farmakodynamiky, farmakokinetiky a imunogenity přípravku efgartigimod PH20 podávaného subkutánně účastníkům ve věku 18 a více let s aktivní idiopatickou zánětlivou myopatií |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Has completed ARGX-113-2007
- Is capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and the following: • women of childbearing potential (WOCBP) must have a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
Exclusion criteria 4
- Intention to have major surgery during the ARGX-113-2011 study period; or any other medical condition that has arisen since enrollment in ARGX-113-2007, that in the investigator’s opinion, would confound the results of the study or put the participant at undue risk
- Known hypersensitivity to investigational medicinal product (IMP) or 1 of its excipients
- Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
- Permanent discontinuation of investigational medicinal product (IMP) in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time
- Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters over time
Secondary endpoints 7
- Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS), and Glucocorticoid Toxicity Index - Metabolic Domains (GTI-MD), over time
- Prednisone dose reduction (average monthly dose) over time
- Total improvement score (TIS) over time
- Proportion of TIS responders (minimal, moderate, major) over time
- Individual core set measure (CSMs) of the TIS over time
- Percentage of participants with clinically inactive disease, defined as no evidence of disease activity, based on an Physician Global Assessment of Disease Activity (MDGA) and Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) of 0 and normal creatine kinase (CK) values for at least 12 weeks (at week 28 and every 24 weeks thereafter)
- Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks, during the study
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11164813 · Product
- Active substance
- Efgartigimod Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 143 mg milligram(s)
- Max total dose
- 221793 mg milligram(s)
- Max treatment duration
- 51 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ARGENX BV
- Paediatric formulation
- No
- Orphan designation
- No
PRD10310851 · Product
- Active substance
- Efgartigimod Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 143 mg milligram(s)
- Max total dose
- 221793 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ARGEN-X BVBA
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 14
SUB09098MIG · Substance
- Active substance
- Mycophenolic Acid
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 4653000 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08872MIG · Substance
- Active substance
- Methylprednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 24816 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 4653 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08424MIG · Substance
- Active substance
- Leflunomide
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 31020 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 4653 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05647MIG · Substance
- Active substance
- Azathioprine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 387750 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 4653000 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 3.5 mg milligram(s)
- Max total dose
- 5428 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02587MIG · Substance
- Active substance
- Hydroxychloroquine Sulfate
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 930600 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 3.5 mg milligram(s)
- Max total dose
- 5428 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 124080 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06250MIG · Substance
- Active substance
- Ciclosporin
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 620400 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05797MIG · Substance
- Active substance
- Betamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 4653 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10018MIG · Substance
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 31020 mg milligram(s)
- Max treatment duration
- 51 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Argenx
- Sponsor organisation
- Argenx
- Address
- Industriepark-Zwijnaarde 7
- City
- Gent
- Postcode
- 9052
- Country
- Belgium
Scientific contact point
- Organisation
- Argenx
- Contact name
- Regulatory
Public contact point
- Organisation
- Argenx
- Contact name
- Regulatory
Third parties 16
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Medical Equipment Supplies And Management Limited ORG-100044212
|
Chorley, United Kingdom | Other |
| Mayo Collaborative Services LLC ORG-100046687
|
Rochester, United States | Other |
| Gray Consulting Inc. ORG-100044159
|
Philadelphia, United States | Other |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | Other |
| Imperial Clinical Research Services International Limited ORG-100037442
|
Shepperton, United Kingdom | Other |
| Azenta Germany GmbH ORG-100039257
|
Griesheim, Germany | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 13, Other, Code 2, Code 5, Code 8 |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Data management, E-data capture |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Other, Laboratory analysis |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Other |
| Accellacare Limited ORG-100044508
|
Dublin 18, Ireland | Other |
| Drug Development Solutions Limited ORG-100045894
|
Ely, United Kingdom | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other, Code 8 |
| The Doctors Laboratory Limited ORG-100012670
|
London, United Kingdom | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
Locations
19 EU/EEA countries · 63 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 2 | 2 |
| Belgium | Ongoing, recruiting | 7 | 6 |
| Bulgaria | Ongoing, recruitment ended | 2 | 2 |
| Cyprus | Ended | 2 | 1 |
| Czechia | Ongoing, recruitment ended | 2 | 1 |
| Denmark | Ongoing, recruitment ended | 1 | 1 |
| France | Ended | 3 | 4 |
| Germany | Ongoing, recruiting | 10 | 9 |
| Greece | Ongoing, recruitment ended | 3 | 5 |
| Hungary | Ended | 3 | 2 |
| Ireland | Ongoing, recruitment ended | 4 | 3 |
| Italy | Ongoing, recruiting | 11 | 7 |
| Lithuania | Ended | 3 | 2 |
| Netherlands | Ongoing, recruitment ended | 3 | 2 |
| Poland | Ongoing, recruitment ended | 5 | 3 |
| Portugal | Ended | 3 | 2 |
| Slovakia | Ended | 1 | 1 |
| Spain | Ongoing, recruitment ended | 13 | 9 |
| Sweden | Ended | 2 | 1 |
| Rest of world
Georgia, Taiwan, Turkey, Canada, Peru, Serbia, United States, Thailand, Switzerland, Argentina, Korea, Republic of, Japan, Israel, Australia, United Kingdom, Mexico
|
— | 160 | — |
Investigational sites
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Allgemeines Krankenhaus der Stadt Wien (AKH), Divison of Rheumatology, Medicine III, Waehringer Guertel 18-20, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Department of Neurology, Anichstrasse 35, 6020, Innsbruck
UZ Leuven
Department of Neurschience, Herestraat 49, 3000, Leuven
Az Sint-Lucas & Volkskliniek
Neurology department, Groenebriel 1, 9000, Gent
Universitair Ziekenhuis Gent
Rheumatology Department, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Department of general internal medicine, Herestraat 49, 3000, Leuven
CHU De Liege
Rheumatology Department, Avenue De L'hopital 1, 4000, Liege
ISPPC CHU Charleroi
Neurology department – C.H.U. de Charleroi Site Hôpital Civil Marie Curie (HCMC), Boulevard Zoe Drion 1, 6000, Charleroi
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Clinic of Rheumatology, Zapaden District, Sofia Str 64, Plovdiv
Medical Center Artmed Ltd.
N/A, Ulitsa Mladost 8, 4002, Plovdiv
The Cyprus Foundation For Muscular Dystrophy Research
Neuromuscular Disorders Centre, Iroon Avenue 6, 2371, Agios Dometios
Rigshospitalet
Center for Rheumatology and Spine Diseases, Juliane Maries Vej 10, 2100 Copenhagen., Blegdamsvej 9, 2100, Copenhagen Oe
Hospital Edouard Herriot
Internal Medicine, 5 Place D Arsonval, 69437, Lyon Cedex 03
Les Hopitaux Universitaires De Strasbourg
Rheumatology Department, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Assistance Publique Hopitaux De Paris
Internal Medicine, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
CHU De Rouen
Internal Medicine, 1 Rue De Germont, Bp 96031, Rouen Cedex
St. Josef Stift GmbH
Klinik für Rheumatologie und Klinische Immunologie, Westtor 7, 48324, Sendenhorst
Universitaetsmedizin Goettingen
Klinik für Neurologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Ulm AöR
Klinik für Neurogeriatrie und Neurologische Rehabilitation Oberer, Oberer Eselsberg 45, Eselsberg, Ulm
Universitaetsklinikum Duesseldorf AöR
Klinik für Neurologie, Moorenstrasse 5, Bilk, Duesseldorf
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie, Chariteplatz 1, Mitte, Berlin
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
N/A, Claudiusstrasse 45, Wanne, Herne
Universitaetsklinikum Tuebingen AöR
Neurologische Universitätsklinik, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
University Medical Center Hamburg-Eppendorf
III. Medizinische Klinik und Poliklinik – Nephrologie/Endokrinologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Mannheim GmbH
Neurologische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Eginitio Hospital
A’ Neurology Department of University of Athens, Vassilissas Sofias Avenue 74, 115 28, Athens
Athens Medical Center S.A.
Department of Neuroimmunology, Distomou 5-7, 151 25, Maroussi
University General Hospital Of Ioannina
Neurology Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Attikon
B’ Neurology Clinic, Rimini Street 1, 124 62, Athens
Laiko General Hospital Of Athens
Department of Pathophysiology, Agiou Thoma (goudi) 17, 115 27, Athens
Semmelweis University
Genomika Medicina és Ritka Betegségek Intézete, Gyulai Pal Utca 2, Kerulet, Budapest VIII
University Of Debrecen
Belgyógyászati Klinika, Immunológia, Moricz Zsigmond Korut 22, 4032, Debrecen
St Vincent's University Hospital
Rheumatology, Nutley Lane, Elm Park, Dublin 4
Our Ladys Hospital Manorhamilton
Rheumatology, Hospital Road, Manorhamilton, Sligo
Connolly Hospital
Rheumatology, Mill Road, Abbotstown, Dublin 15
Azienda Ospedaliero Universitaria Pisana
Rheumatology, Via Roma 67, 56126, Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
lnstitute of Neurology, Largo Francesco Vito 1, 00168, Rome
Humanitas Research Hospital
Rheumatology and Clinical Immunology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Reumatology Institute, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliero-Universitaria Sant Andre
OUC Neurologia, Via Di Grottarossa 1035-1039, 00189, Rome
Ospedale San Raffaele S.r.l.
Neuromuscular Repair Unit, Via Olgettina 60, 20132, Milan
Azienda Sanitaria Universitaria Friuli Centrale
SOC Clinica di Reumatologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Clinic of Rheumatology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Rheumatology Center, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Academisch Medisch Centrum
Department of Neurolog, Meibergdreef 9, 1105 AZ, Amsterdam
University Medical Center Utrecht
Rheumatology & Clinical Immunology, Heidelberglaan 100, 3584 CX, Utrecht
Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie
N/A, ul. Unii Lubelskiej 1, 71-252, Szczecin
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi SPZOZ
Klinika Reumatologii i Immunologii Klinicznej z Pododdzialem Chorob Wewnetrznych, ul. Stefana Zeromskiego 113, 90-549, Lodz
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Clinical Immunology, Largo Professor Abel Salazar, 4050-011, Porto
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Rheumatology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Narodny Ustav Reumatickych Chorob
Reumatologická ambulancia, Nabrezie Ivana Krasku 4782/4, 921 01, Piestany
Hospital Universitario Ramon Y Cajal
Rheumatology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario La Paz
Rheumatology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Virgen De Valme
Rheumatology, Avenida Bellavista S/n, 41014, Sevilla
Complexo Hospitalario Universitario De Vigo
Rheumatology – Hospital Do Meixoeiro, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital General Universitario Dr. Balmis
Neurology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital De La Santa Creu I Sant Pau
Rheumatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Neurology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
Rheumatology, Bloque D, Avenida De Cordoba S/n, Madrid
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 |
|---|---|---|---|---|---|
| Austria | 2024-07-16 | 2024-07-16 | 2025-05-30 | ||
| Belgium | 2023-12-14 | 2023-12-14 | |||
| Bulgaria | 2023-09-20 | 2023-09-20 | 2026-01-19 | ||
| Cyprus | 2024-03-20 | 2025-05-22 | 2024-03-20 | ||
| Czechia | 2024-04-03 | 2024-04-03 | 2025-11-18 | ||
| Denmark | 2024-01-25 | 2024-01-25 | 2025-11-13 | ||
| France | 2024-05-13 | 2025-05-12 | 2024-05-13 | 2024-05-13 | |
| Germany | 2024-03-26 | 2024-03-26 | |||
| Greece | 2023-12-18 | 2023-12-18 | 2026-02-04 | ||
| Ireland | 2025-12-04 | 2025-12-04 | 2025-12-04 | ||
| Italy | 2024-04-15 | 2024-04-15 | |||
| Lithuania | 2023-11-13 | 2025-05-22 | 2023-11-13 | ||
| Netherlands | 2025-04-08 | 2025-04-08 | 2025-04-08 | ||
| Poland | 2024-06-06 | 2024-06-06 | 2025-05-30 | ||
| Portugal | 2025-04-28 | 2025-08-22 | 2025-04-28 | ||
| Spain | 2024-06-05 | 2024-06-05 | 2025-11-12 | ||
| Sweden | 2024-04-03 | 2025-05-31 | 2024-04-03 | 2025-05-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 350 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ARGX-113-2011_CRF | 1.0 |
| Protocol (for publication) | D1_ARGX-113-2011_Protocol Clarification Letter | N/A |
| Protocol (for publication) | D1_ARGX-113-2011_Protocol Clarification Letter_GR | N/A |
| Protocol (for publication) | D1_Protocol_2022-502851-79_en_FP | 4.0 |
| Protocol (for publication) | D1_Protocol_2022-502851-79_GR_el_FP | 4.0 |
| Protocol (for publication) | D4_ARGX-113-2011_Memo_Docs Electronic Adaptation | N/A |
| Protocol (for publication) | D4_ARGX-113-2011_NTF_eCOA_header adaptation | N/A |
| Protocol (for publication) | D4_Statement_Questionnaires_FP | N/A |
| Recruitment arrangements (for publication) | K_Recruitment_arrangements_Eng | NA |
| Recruitment arrangements (for publication) | K1_Clincierge_Data Protection Notice | 1.0 |
| Recruitment arrangements (for publication) | K1_Clincierge_PayPortalGuide | 1.0 |
| Recruitment arrangements (for publication) | K1_Clincierge_TravelPolicy | 1.0 |
| Recruitment arrangements (for publication) | K1_Clincierge_WelcomeLetter | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | NA |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | NA |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | 3 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | 1 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | NA |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process | NA |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_cze | NA |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_eng | NA |
| Recruitment arrangements (for publication) | K1_Recruit-ICF-Process | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | NA |
| Recruitment arrangements (for publication) | K1_Recruitment process | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment process | NA |
| Recruitment arrangements (for publication) | K2_No recruitment material statement | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Blank Statement | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_SVG_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_Subject Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_ARGX-113-2011 SIS-ICF_Clincierge | N/A |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnancy and Birth_German | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy and Birth_Dutch | 1.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnancy and Birth_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_Country Deselected Subtype Addendum_Already Enrolled_BGN_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_Country Deselected Subtype Addendum_Already Enrolled_ENG_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnancy and Birth_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnancy and Birth_German | 1.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnancy Birth_Spanish | 1.1 |
| Subject information and informed consent form (for publication) | L1_GR_SIS-ICF_Pregnancy and Birth_Greek | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum Covid-19_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum Covid-19_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_en_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Master Addendum COVID-19 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Master Caregiver ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Master Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Master Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Pregnant Partner_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_IE_SIS-ICF_Pregnancy and Birth | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnancy Birth_Italian | 1.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnancy and Birth_Dutch | 1.2 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnancy and Birth_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Caregiver_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF Covid Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Future Research | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Main_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Pregnant Partner | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Addendum Deselected Subtype_Already Enrolled_en_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Addendum Deselected Subtype_Already Enrolled_fr_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Addendum Deselected Subtype_Already Enrolled_nl_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Addendum Deselected Subtype_Rolling Over_en_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Addendum Deselected Subtype_Rolling Over_fr_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Addendum Deselected Subtype_Rolling Over_nl_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Caregiver | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Caregiver_en_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Caregiver_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Caregiver_fr_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Caregiver_nl_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF COVID Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Deselected Subtype Addendum_Already Enrolled_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Deselected Subtype Addendum_Already Enrolled_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Deselected Subtype Addendum_Rolling Over_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Deselected Subtype Addendum_Rolling Over_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main Deselected Subtype_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main Deselected Subtype_fr_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main Deselected Subtype_nl_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_AUMC_van der Kooi | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_Deselected Subtype_FP | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_en_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_fr_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_nl_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_UMCU_Dr Leavis | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_en_FP | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_fr_FP | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_nl_FP | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_1-2 Main for Deselected_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_10 Addendum Rolling from-2007_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_11 Addendum Enrolled in-2011_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addend for Enroll in 2011_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addend Roll from 2007_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Already Enrolled_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum already enrolled_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Already Enrolled_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Already Enrolled_ru_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Covid-19 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum COVID-19 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum COVID-19 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Deselected Subtype Already Enrolled_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Deselected Subtype Rolling Over_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum for Enrolled in-2011_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum for Enrolled in-2011_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum for Rolling from-2007_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum for Rolling from-2007_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Main ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum rolling over from ARGX 113 2007_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Rolling over_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Rolling over_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum Rolling over_ru_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum_Enrolled_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Addendum_Rollover_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Biomarker | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_CAREGIVER ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver_bg_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver_en_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver_FOR ENROLLED_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver_Hun | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Caregiver_ru_FP | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Clincierge | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Deselected Subtype Addendum_Rolling over_BGN_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Deselected Subtype Addendum_Rolling over_ENG_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Main Deselected Subtype_BGN_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Main Deselected Subtype_ENG_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_COVID Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Covid Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Covid addendum | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_COVID Addendum_ru_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_COVID_Addendum_Hun | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_COVID-19 Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_COVID-19 Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_COVID-19 Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Data Privacy | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum Already Enrolled_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Already Enrolled_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Already Enrolled_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Already Enrolled_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Enrolled 2011_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Rolling over 2007_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Rolling Over_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Rolling Over_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Rolling Over_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtype Addendum_Rolling Over_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtypes_Already Enrolled_ICF Addendum_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Deselected Subtypes_Rolling Over_ICF Addendum_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_FBR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Future research | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Future research_ru_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Future Sample Research | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Home Care | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Completed_lt_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Completed_ru_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Deselected Sub-group_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Deselected Subtype_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Deselected Subtype_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Deselected_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main for Deselected Subtype of ARGX-113-2007_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main for Deselected Subtype_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main for enrolled_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main ICF_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_MAIN ICF_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Rolled over from ARGX 113 2007_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_bg_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Deselected Subgroup 113 2007_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Deselected Subtype of ARGX 113 2007_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Deselected Subtype of ARGX 113 2007_ru_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Deselected Subtype_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Deselected Subtype_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Deselected_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_hu_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_Rollover 2007_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Master Deselected Subtype Addendum_Already Enrolled_ENG_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Master Deselected Subtype Addendum_Rolling over_ENG_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Master Main Deselected Subtype_ENG_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Optional Future Research | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Optional Photography | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Participants_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Photography | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PP ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | N/A |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_Hun | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_ru_FP | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy Statement | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy Statement_FOR ENROLLED_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy Supplement_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SISICF Main Deselected Subtype_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SISICF_Caregiver | 2.0 |
| Subject information and informed consent form (for publication) | L1_SISICF_Clincierge_PFD_Data Protection Notice | 1 |
| Subject information and informed consent form (for publication) | L1_SISICF_COVID Addendum to Main ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SISICF_Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SISICF_PP | 1 |
| Subject information and informed consent form (for publication) | L1b_Sponsor statement | NA |
| Subject information and informed consent form (for publication) | L2_ARGX-113-2011_Clincierge Data Protection Notice | 1.0 |
| Subject information and informed consent form (for publication) | L2_ARGX-113-2011_Clincierge Data Protection Notice | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge Data Consent Form | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge Data Consent Form | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge Data Consent Form_ru_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge Pay Portal Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge Travel Policy | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge Travel Policy | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge Travel Policy_ru_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge Welcome Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge Welcome Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge Welcome Letter_ru_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Data Protection Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PayPortalGuide | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Data Protection Notice | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Data Protection Notice_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Data Protection Notice_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Pay Portal Guide_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Pay Portal Guide_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_PayPortalGuide | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Travel Policy_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Travel Policy_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_TravelPolicy | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Welcome Letter_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_Welcome Letter_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clincierge_PFD_WelcomeLetter | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_TravelPolicy | 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_WelcomeLetter | 1 |
| Subject information and informed consent form (for publication) | L2_GP Letter | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_BGN | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_ENG | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP letter_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP letter_ru_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home Guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home Guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home Guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home Guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home guide_BGB | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home guide_ENG | 2.0 |
| Subject information and informed consent form (for publication) | L2_Home Guide_ru_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_Instructions for Use PFS_FP | 1 |
| Subject information and informed consent form (for publication) | L2_IP Prep and Admin Log SC PFS_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_List of Submitted Documents_FP | N/A |
| Subject information and informed consent form (for publication) | L2_OLE PATIENT EMERGENCY_ID CARD | 1 |
| Subject information and informed consent form (for publication) | L2_Other information SVG_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other information_SVG_Placeholder_FP | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_SVG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SVG_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_centre-specific contact list_FP | N/A |
| Subject information and informed consent form (for publication) | L2_Patient and Emergency ID Card | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Diary | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Diary | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Diary | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Diary | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Diary | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Diary_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Diary_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Diary_ru_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient emergency and ID Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_PATIENT EMERGENCY and ID CARD_BGN | 1.0 |
| Subject information and informed consent form (for publication) | L2_PATIENT EMERGENCY and ID CARD_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient emergency and ID Card_ru_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Emergency ID Card | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Emergency ID Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Pt_card_Hun | 1.0 |
| Subject information and informed consent form (for publication) | L2_SC self administration video | N/A |
| Subject information and informed consent form (for publication) | L2_SC Self-Administration Video | NA |
| Subject information and informed consent form (for publication) | L2_SC Self-Administration Video Wave 4Transcript | NA |
| Subject information and informed consent form (for publication) | L2_SC Self-Administration Video_ru_FP | N/A |
| Subject information and informed consent form (for publication) | L2_Self Administration Video Wave 4 Transcript | NA |
| Subject information and informed consent form (for publication) | L2_Self Administration Video Wave 4 Transcript | N/A |
| Subject information and informed consent form (for publication) | L2_Self Administration Video wave4 Transcript | NA |
| Subject information and informed consent form (for publication) | L2_Statement_Questionnaires | N/A |
| Subject information and informed consent form (for publication) | L2_Statement_Questionnaires | N/A |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide | 4.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_bg_FP | 4.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_en_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_fr_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_nl_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_Placeholder_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Study Visit Guide_ru_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_SVG_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Transcript_SC self administration video | NA |
| Subject information and informed consent form (for publication) | L2_Transcript_SC self administration video | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_bg_BG_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_cs_CZ_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_de_AT_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_de_BE_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_el_CY_2022-502851-79_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_el_GR_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_en_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_es_ES_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_fr_BE_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_fr_FR_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_hu_HU_2022-502851-79_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_it_IT_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_lt_LT_2022-502851-79_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_nl_BE_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_nl_NL_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_pl_PL_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_pt_PT_2022-502851-79_FP | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_se_SV_2022-502851-79_FP | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_sk_SK_2022-502851-79_FP | 3.0 |
Application history
23 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-12 | Austria | Acceptable 2023-09-04
|
2023-09-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-12 | Acceptable 2023-09-04
|
2023-09-12 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-02 | Acceptable | 2023-12-13 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-02 | Acceptable | 2023-11-15 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-10-02 | Acceptable | 2023-11-03 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-02 | Acceptable | 2023-11-13 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-08 | Acceptable | 2024-06-17 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-06-28 | Austria | Acceptable 2024-10-07
|
2024-10-08 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-17 | Austria | Acceptable 2024-10-07
|
2025-01-17 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-01 | Austria | Acceptable with conditions 2025-07-07
|
2025-07-08 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-15 | Acceptable with conditions | 2025-07-30 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-08-08 | Acceptable with conditions | 2025-09-24 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-10-30 | Austria | Acceptable 2026-02-16
|
2026-02-17 |
| 14 | SUBSTANTIAL MODIFICATION | SM-19 | 2026-03-02 | Acceptable | 2026-04-13 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-20 | 2026-03-02 | Acceptable | 2026-04-24 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-23 | 2026-03-03 | Acceptable | 2026-03-27 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-25 | 2026-03-03 | Acceptable | 2026-04-20 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-03-03 | Austria | Acceptable | 2026-04-27 |
| 19 | SUBSTANTIAL MODIFICATION | SM-17 | 2026-03-03 | Acceptable | 2026-03-06 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-22 | 2026-03-03 | Acceptable | 2026-05-20 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-15 | 2026-03-04 | Acceptable | 2026-04-02 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-24 | 2026-03-05 | Acceptable | 2026-05-21 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-21 | 2026-03-05 | Acceptable | 2026-04-17 |