A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjogrens Syndrome

Bristol-Myers Squibb K.K.0 个研究点目标入组 172 人开始时间: 2017年2月24日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

•Subjects must meet the 2016 ACR/EULAR Classification Criteria for SS (Sjogren's Syndrome), as specified for pSS.
•Subjects should have pSS that is refractory to symptomatic or local therapy (e.g. NSAIDs)
•Subjects having an ESSDAI score of at least 5 at screening.
•Subjects being anti-SS-A/Ro positive at screening.
•Stimulated salivary flow of at least 0.1 mL/min at screening and randomization in at least 124 subjects (72%)

•Subjects who have a systemic autoimmune disease other than Sjogren's syndrome, such as RA, SLE or systemic sclerosis, that can better explain the majority of the symptoms (ie, secondary Sjogren's syndrome).
•Subjects who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of pSS to therapy (eg, systemic sclerosis, inflammatory bowel disease, gout).
•Subjects with any other medical condition associated with clinical features overlapping those of pSS or that would interfere with interpretation of results, including but not limited to a history of head and neck radiation treatment, sarcoidosis, amyloidosis, graft-versus-host disease, hepatitis C, acquired immunodeficiency syndrome, and IgG4-related disease.
•Active life-threatening or organ-threatening complications of SS disease at the time of screening based on investigator evaluation

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