Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
370
Countries
2
Sites
4
Psoriatic arthritis
To evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-target approach on maintaining minimal disease activity (MDA) in adult subjects with psoriatic arthritis (PsA) and stable MDA.
Key facts
- Sponsor
- Universitaetsklinikum Erlangen AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 18 Sep 2020 → ongoing
- Decision date (initial)
- 2023-10-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508251-39-00
- EudraCT number
- 2020-001899-14
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-target approach on maintaining minimal disease activity (MDA) in adult subjects with psoriatic arthritis (PsA) and stable MDA.
Secondary objectives 2
- To investigate the effects of tapering systemic immunosuppressive therapy on multidimensional aspects of PsA disease activity.
- To investigate the effects of tapering systemic immunosuppressive therapy on subject safety.
Conditions and MedDRA coding
Psoriatic arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10037162 | Psoriatic arthropathy | 100000004859 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Written informed consent obtained from the subject
- Adult male or female subject; age ≥18
- Diagnosis of PsA according to CASPAR criteria
- Disease status “MDA” for at least 6 months; MDA is defined as the presence of 5 of the following 7 criteria: a) tender joint count ≤1 b) swollen joint count ≤1 c) tender entheseal point count ≤1 (means: remission) d) PASI ≤1 OR body surface area (BSA) ≤3% e) patient pain VAS ≤15 f) patient global activity VAS ≤20 g) HAQ-DI ≤0.5
- Disease status “MDA+” at screening and baseline; MDA+ is defined as the presence of 5 of the 7 criteria for MDA, whereby all musculoskeletal domains a)-c) must fulfil the criteria
- Subject should have been treated without alterations of therapy (fixed dose and drug) for at least 6 months with one or more of the following drugs: a) csDMARD Leflunomide (e.g. Arava), Sulfasalazine (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) AND/OR b) bDMARD/tsDMARD Etanercept (e.g. Enbrel, Erelzi, Benepali), Adalimumab (e.g. Humira, Amgevita, Imraldi, Hyrimoz), Infliximab (e.g. Remicade, Zessly, Inflectra), Golimumab (Simponi), Certolizumab (Cimzia), Abatacept (Orencia), Apremilast (Otezla), Ustekinumab (Stelara), Secukinumab (Cosentyx), Ixekizumab (Taltz), Guselkumab (Tremfya) Upadacitinib (Rinvoq) Risankizumab (Skyrizi) Tofacitinib (Xeljanz) AND/OR c. Glucocorticoids (≤ 5mg prednisolone equivalent)
Exclusion criteria 6
- Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener
- Concomitant florid immune mediated disease such as autoimmune hepatitis that is untreated and/or requires immunosuppressive treatment.
- Use of any inadmissible medication (e.g. current treatment with DMARDs other than mentioned above or drugs under development)
- Treatment with systemic glucocorticoids (daily dose >5mg prednisolone equivalent) during the last 6 months before randomization. Intra-articular or entheseal injections of glucocorticoids do not constitute an exclusion criterion
- Nursing mother or pregnant woman
- Any anti-inflammatory (excluding NSAIDs) or immunosuppressive therapy for other reasons than PsA or psoriasis during the last 3 months before screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Presence of minimal disease activity (MDA ) 12 months after baseline.
- Mean PASDAS at month-12.
Secondary endpoints 16
- Key secondary endpoints: PASDAS, DAPSA and mCPDAI
- Number of swollen and tender joints
- Number of tender entheseal points (SPARCC, LEI, MASES entheseal point counts)
- Dactylitis counts
- Activity of psoriasis (PASI, BSA)
- Activity of axial involvement (BASDAI)
- Quality of life and health/disability (PsAID-12, HAQ-DI, DLQI, ASQoL, SF-36)
- Pain (VAS)
- Proportion of patients with loss of MDA within 12 months after baseline
- Proportion of patients with loss of MDA within 24 months after baseline
- Time to loss of MDA
- Time needed to restore MDA after readjustment of the DMARD therapy in subjects who lost MDA within the intervention period
- Biomarker levels
- Intervention-related events within the observation period of 24 months after baseline
- AE, AR, SAE, SAR, SUSAR
- Subjective (SACRAH, DASH, MHQshort) and objective (grip strength (lbf) and moberg-pick up test (s) hand function
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 25
Tremfya 100 mg solution for injection in pre-filled pen.
PRD6533971 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC16 — -
- Marketing authorisation
- EU/1/17/1234/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled syringe
PRD646173 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 13000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/010
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 250 mg powder for concentrate for solution for infusion
PRD363752 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 26000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ORENCIA 125 mg solution for injection in pre-filled pen
PRD2991508 · Product
- Active substance
- Abatacept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 1300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — -
- Marketing authorisation
- EU/1/07/389/011
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 2080 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Otezla 30 mg film-coated tablets
PRD7877793 · Product
- Active substance
- Apremilast
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 43.8 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA32 — -
- Marketing authorisation
- EU/1/14/981/002
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Taltz 80 mg solution for injection in pre-filled pen
PRD3995199 · Product
- Active substance
- Ixekizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 2080 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC13 — -
- Marketing authorisation
- EU/1/15/1085/001
- MA holder
- ELI LILLY AND COMPANY (IRELAND) LIMITED
- MA country
- EU
- 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
- 50 mg milligram(s)
- Max total dose
- 36.5 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
XELJANZ 11 mg prolonged-release tablets
PRD7775421 · Product
- Active substance
- Tofacitinib
- Substance synonyms
- CP-609,550, TASOCITINIB
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 11 mg milligram(s)
- Max total dose
- 8030 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA29 — -
- Marketing authorisation
- EU/1/17/1178/010
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
XELJANZ 5 mg film-coated tablets
PRD4862356 · Product
- Active substance
- Tofacitinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 7300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA29 — -
- Marketing authorisation
- EU/1/17/1178/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RINVOQ 15 mg prolonged-release tablets
PRD7789002 · Product
- Active substance
- Upadacitinib
- Substance synonyms
- (3S,4R)-3-ETHYL-4-(1,5,7,10-TETRAZATRICYCLO[7.3.0.0]DODECA-2(6),3,7,9,11-PENTAEN-12-YL)-N-(2,2,2-TRIFLUOROETHYL)PYRROLIDINE-1-CARBOXAMIDE, ABT-494
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 10950 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA44 — -
- Marketing authorisation
- EU/1/19/1404/001
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 65 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 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
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14.6 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16442MIG · Substance
- Active substance
- Methotrexate Disodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 2600 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10727MIG · Substance
- Active substance
- Sulfasalazine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 1460 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Skyrizi 150 mg solution for injection in pre-filled syringe
PRD8999092 · Product
- Active substance
- Risankizumab
- Substance synonyms
- BI 655066, ABBV-066
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 1300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC18 — -
- Marketing authorisation
- EU/1/19/1361/003
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cimzia 200 mg solution for injection in dose-dispenser cartridge
PRD4989149 · Product
- Active substance
- Certolizumab Pegol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 10400 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB05 — -
- Marketing authorisation
- EU/1/09/544/008
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cimzia 200 mg solution for injection in pre-filled syringe
PRD2148621 · Product
- Active substance
- Certolizumab Pegol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 10400 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB05 — -
- Marketing authorisation
- EU/1/09/544/004
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cimzia 200 mg solution for injection in pre-filled pen
PRD4398501 · Product
- Active substance
- Certolizumab Pegol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 10400 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB05 — -
- Marketing authorisation
- EU/1/09/544/005
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Simponi 50 mg solution for injection in pre-filled syringe.
PRD708229 · Product
- Active substance
- Golimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 1300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB06 — -
- Marketing authorisation
- EU/1/09/546/004
- MA holder
- JANSSEN BIOLOGICS B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
STELARA 45 mg solution for injection
PRD709636 · Product
- Active substance
- Ustekinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 780 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC05 — -
- Marketing authorisation
- EU/1/08/494/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16442MIG · Substance
- Active substance
- Methotrexate Disodium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 3120 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01984MIG · Substance
- Active substance
- Etanercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 5.2 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cosentyx 150 mg solution for injection in pre-filled pen
PRD2398837 · Product
- Active substance
- Secukinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC10 — -
- Marketing authorisation
- EU/1/14/980/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cosentyx 150 mg solution for injection in pre-filled syringe
PRD2398835 · Product
- Active substance
- Secukinumab
- Substance synonyms
- Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 7800 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC10 — -
- Marketing authorisation
- EU/1/14/980/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Erlangen AöR
- Sponsor organisation
- Universitaetsklinikum Erlangen AöR
- Address
- Maximiliansplatz 2, Innenstadt Innenstadt
- City
- Erlangen
- Postcode
- 91054
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Prof. Dr. med. Georg Schett
Public contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Prof. Dr. med. Georg Schett
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 270 | 3 |
| Italy | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Klinikum Nuernberg
Klinik für Innere Medizin 5, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
InnKlinikum Burghausen
MED Bayern OST MVZ Burghausen Altötting, Krankenhausstrasse 1, 84489, Burghausen
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 3, Ulmenweg 18, Innenstadt, Erlangen
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 |
|---|---|---|---|---|---|
| Germany | 2020-09-18 | 2020-10-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-508251-39 | 3 |
| Protocol (for publication) | D1_Synopsis_IT_2023-508251-39 | 1.1 |
| Protocol (for publication) | D4_Patient_Diary_IT_2023-508251-39 | 1.0 |
| Protocol (for publication) | D4_Patient_Diary_Master_DE | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR01_SmPC_Prednisolone_Prednisolone_10mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR01_SmPC_Prednisolone_Prednisolone_1mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR01_SmPC_Prednisolone_Prednisolone_20mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR01_SmPC_Prednisolone_Prednisolone_5mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR02_SmPC_Salazopyrin_Sulfasalazine | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR03_SmPC_Arava_Leflunomide_100mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR03_SmPC_medac_Leflunomide_10_15_20mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR04_SmPC_Metotab_MTX_po | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR05_SmPC_Metoject_MTX_sc | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR06_PR22_SmPC_Xeljanz_Tofacitinib | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR07_SmPC_Otezla_Apremilast | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR08_SmPC_Enbrel_Etanercept | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR09_SmPC_AMGEVITA_Adalimumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR10_SmPC_Remicade_Infliximab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR11_SmPC_Simponi_Golinumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR12_PR17_PR18_SmPC_Cimzia_CertolizumabPegol | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR13_PR14_PR19_SmPC_Orencia_Abatacept | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR15_PR20_SmPC_Cosentyx_Secukinumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR16_SmPC_Taltz_Ixekizumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR21_SmPC_Stelara_Ustekinumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR23_SmPC_Rinvoq_Upadacitinib | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR24_SmPC_Tremfya_Guselkumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PR25_SmPC_Skyrizi_Risankizumab | NA |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-20 | Germany | Acceptable 2023-09-28
|
2023-10-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-29 | Germany | Acceptable 2024-02-29
|
2024-03-05 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-05-02 | 2024-07-24 | ||
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-20 | Germany | 2026-01-20 |