EUCTR2020-001899-14-DE进行中（未招募）1 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 - ATTRACTOR
niversitätsklinikum Erlangen0 个研究点目标入组 270 人开始时间: 2020年7月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Diagnosis of PsA according to CASPAR criteria
- •- male or female adult subject; age >=18 years
- •- 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 =3
- •e) patient pain VAS =15
- •f) patient global activity VAS =20
- •g) HAQ-DI =0.5
- •- Disease Status MDA+; MDA+ is defined as the presence of 5 of the 7 criteria for MDA, whereby all musculoskeletal Domains a)-c) must fulfil the criteria
- •-suject 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:
- •Leflunomid (e.g. Arava),
- •Sulfasalazin (e.g. Azulfidine RA, Pleon RA),
- •Methotrexate (e.g. Lantarel, Metex)
- •ii. 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)
- •(c) glucocorticoids (=5mg prednisolone equivalent).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
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
- •- Malignant disease or history of malignant disease within 5 years prior to screening, which could affect the reduction of immunosuppressive therapy
- •- Existence of another disease including the presence of laboratory abnormalities which, at the discretion of the investigator, would result in a disproportionate risk to the patient concerned or confounds the ability to interpret data from the study
- •- Any anti-inflammatory (excluding NSAIDs) or immunosuppressive therapy for other reasons than PsA or psoriasis during the last 3 months before screening
- •- Nursing mother or pregnant woman as verified by a positive pregnancy test
- •- Known hypersensitivity to the IMPs or any of their formulation ingredients
研究者
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