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 - UKER-ATTRACTOR-01

niversitaetsklinikum Erlangen AöR0 个研究点目标入组 370 人开始时间: 2023年9月20日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•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)

•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

发起方

niversitaetsklinikum Erlangen AöR