2023-508251-39-00招募中3 期
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
Universitaetsklinikum Erlangen AöR4 个研究点 分布在 2 个国家目标入组 370 人开始时间: 2023年10月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 370
- 试验地点
- 4
- 主要终点
- Presence of minimal disease activity (MDA ) 12 months after baseline.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Presence of minimal disease activity (MDA ) 12 months after baseline.
Presence of minimal disease activity (MDA ) 12 months after baseline.
Mean PASDAS at month-12.
Mean PASDAS at month-12.
次要结局
- Subjective (SACRAH, DASH, MHQshort) and objective (grip strength (lbf) and moberg-pick up test (s) hand function
- 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
研究者
Prof. Dr. med. Georg Schett
Scientific
Universitaetsklinikum Erlangen AöR
研究点 (4)
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