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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
EU CTIS ID: 2023-508251-39-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.