An unblinded clinical Trial with random assignment to Treatment Groups in adult patients with psoriatic arthrits to evaluate how far immunosuppressive medication can be tapered without recurrence of symptoms

Phase 1

Recruiting

• Conditions: Psoriatic arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 21.1Level: PTClassification code: 10037162Term: Psoriatic arthropathy Class: 100000004859

• Registration Number: CTIS2023-508251-39-00
• Lead Sponsor: niversitaetsklinikum Erlangen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-20
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: 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.;Primary end point(s): Presence of minimal disease activity (MDA ) 12 months after baseline., Mean PASDAS at month-12.