Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA). - BN001/S63343

Z Leuven0 个研究点目标入组 20 人开始时间: 2024年2月19日最近更新: 2024年7月22日

适应症

试验速览

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•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

•-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

发起方

Z Leuven