A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sj¿grens Syndrome

Phase 1

• Conditions: MedDRA version: 21.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Adults with moderately to severely Active Primary Sjogrens Syndrome; MedDRA version: 20.1Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 21.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.0Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001948-19-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-23
• Study Start: 2021-05-25
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 249

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