A Phase 3 study of Abatacept in Patients with Primary Sjogrens Syndrome
- Conditions
- Primary Sjogrens Syndrome
- Registration Number
- JPRN-jRCT2080223466
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 172
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method confirmatory<br>The mean change from baseline (Day 1) in ESSDAI at Day 169.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>The mean change from baseline in ESSPRI at Day 169 <br>The mean change from baseline in the stimulated whole salivary flow at Day 169 among subjects with stimulated whole salivary flow of at least 0.1 mL/min at both screening and baseline.