2024-511401-40-00招募中4 期
Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA).
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- - The proportion of patients achieving a status of clinical remission at week 24.
研究概览
简要总结
To evaluate the effect of tofacitinib in remission induction and to document extended drug-free follow-up status after treatment with tofacitinib in early DMARD naïve PsA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Follow up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Clinical diagnosis of PsA made by rheumatologist and fulfilling criteria defined by the classification Criteria for PsA (CASPAR)
- •Onset of PsA symptoms ≤ 24 weeks prior to screening visit
- •Active disease per rheumatologist’ss opinion
- •At least 1 swollen joint which is suitable for ultrasound guided synovial biopsy at BL
- •Women of childbearing age and men capable of fathering children have to use adequate birth control measures during the study and for 6 months after the last administration of the study medication
- •Able and willing to give written informed consent and participate in the study
排除标准
- •Previous treatment with: DMARDs; Oral, IA, IV or IM GC’s within 4 weeks before BL; IA steroids in the target joint ≤ 6 weeks before synovial biopsy; An investigational drug for the treatment/prevention of PsA
- •Alcohol or drug abuse
- •History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex
- •History of malignancies within the last 5 years
- •History of any inflammatory rheumatic disease other than PsA
- •Use of anticoagulation or anti-aggregation therapy (other than low-dose aspirin and NSAIDs)
- •Intolerance/allergy to lidocaine
- •Underlying hematological, thromboembolic, cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
- •Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)
- •Active hepatitis B and C infection
- •Active tuberculosis (TB)
- •Latent TB unless adequate prophylactic treatment is given according to local guidelines
结局指标
主要结局
- The proportion of patients achieving a status of clinical remission at week 24.
- The proportion of patients achieving a status of clinical remission at week 24.
次要结局
- - The proportion of patients in drug-free remission at week 52 and week 104.
- - Time to relapse in patients experiencing a flare after treatment cessation.
- - The evolution of arthritis, dactylitis, enthesitis and skin involvement at week 4, week 12, week 24, week 28, week 52, week 76 and week 104, measured by : SJC66/TJC68; Dactylitis severity score; Leeds enthesitis index; BSA
- - The evolution of patient-reported outcomes at week 4, week 12, week 24, week 28, week 52, week 76 and week 104: PGA; Health Assessment Questionnaire – disability index (HAQ); Short Form-36 physical functioning domain(SF-36); EuroQol 5- dimension Health state Profile (EQ-5D); PsA Impact of Disease (PsAID)
- - Percentage of patients achieving the PsA response criteria (PsARC), minimal disease activity (MDA) and 85% change in Disease activity (DAPSA) at week 12, week 24, week 52, week 76 and week 104
- - Radiographic progression at week 52 and week 104
研究者
Barbara Neerinckx
Scientific
UZ Leuven
研究点 (1)
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