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
Key facts
- Where
- Burghausen, Erlangen és Nuremberg, NémetországSee the 3 sites
- Phase
- 3. fázis
Where in Németország
- InnKlinikum BurghausenBurghausen, NémetországTaking people
- Universitaetsklinikum Erlangen AöRErlangen, NémetországTaking people
- Klinikum NuernbergNuremberg, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Erlangen AöR
- Trial code
- EU 2023-508251-39-00
- Record updated
- 2026. szeptember 28.
- Original description
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.Read full original descriptionShow less
A prospective, randomized, controlled, open label, assessor-blinded, parallel-group Phase III clinical trial to evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-target approach on maintaining minimal disease activity in adult subjects with 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.
Inclusion: 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: 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; Any anti-inflammatory (excluding NSAIDs) or immunosuppressive therapy for other reasons than PsA or psoriasis during the last 3 months before screening; Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener; Nursing mother or pregnant woman.