A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome
Phase 1
- Conditions
- Adults with moderately to severely Active Primary Sjögrens SyndromeMedDRA version: 19.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.0Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.0Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-001948-19-FR
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria
- ESSDAI score of at least 5
- Positive anti-SS-A/Ro antibody at screening
- Meet the proposed 2015 ACR/EULAR Classification Criteria for Sjögren’s Syndrome
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 287
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- Secondary sjogrens syndrome
- Active life-threatening or organ-threatening complications of Sjögren’s-syndrome
- Other medical condition associated with sicca syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The Primary Objective of the study is to compare the mean change from baseline (Day 1) to Day 169 in ESSDAI of abatacept versus placebo in subjects with moderate to severe pSS;Secondary Objective: - To compare the mean change from baseline (Day 1) to Day 169 in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) of abatacept versus placebo in subjects with moderate to severe pSS.<br>- To compare the mean changes from baseline (Day 1) to Day 169 in the stimulated whole salivary flow of abatacept versus placebo in subjects with residual stimulated whole salivary flow of at least 0.1 mL/min at baseline.;Primary end point(s): The mean change from baseline (Day 1) to Day 169 in ESSDAI;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - The change from baseline (Day 1) to Day 169 in ESSPRI <br>- The change from baseline (Day 1) in the stimulated whole salivary flow to Day 169 among subjects with stimulated whole salivary flow of at least 0.1 mL/min<br>- Proportion of subjects with a least one positive immunogenicity response )<br>- Safety (proportion of subjects with adverse events, deaths, SAEs, and AEs leading to discontinuation and proportion of laboratory marked abnormalities) up to Day 169 and during the cumulative abatacept period and follow-up period;Timepoint(s) of evaluation of this end point: - Day 1 to Day 169<br>- Day 1 to Day 169<br>- Day 1 to 84 days after the last dose of study drug<br>- Day 1 to 56 days after the last dose of study drug