Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sj gren's Syndrome or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

  • STATUS
    Recruiting
  • End date
    Feb 10, 2023
  • participants needed
    185
  • sponsor
    Bristol-Myers Squibb
Updated on 12 August 2021
sjogren's syndrome
arthritis
lupus
abatacept
progressive systemic sclerosis

Summary

The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjgren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

Details
Condition Autoimmune disease, CONNECTIVE TISSUE DISEASE, Rheumatoid Arthritis, SYSTEMIC LUPUS ERYTHEMATOSUS, Autoimmunity, Rheumatoid Arthritis (Pediatric), Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, autoimmune diseases, autoimmune disorder, autoimmune disorders, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome
Treatment Abatacept, branebrutinib, branebrutinib placebo
Clinical Study IdentifierNCT04186871
SponsorBristol-Myers Squibb
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Sub-study for Systemic Lupus Erythematosus (SLE)
Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
Diagnosed with SLE more than 24 weeks before screening visit
Sub-study for primary Sjgren's Syndrome (pSS)
Moderate to severe pSS, meeting ACR-EULAR classification criteria
Sub-study for active Rheumatoid Arthritis (RA)
Moderate to severe adult-onset RA
ACR global functional status class I to III
Women and men must agree to follow instructions for methods of contraception

Exclusion Criteria

Sub-study for Systemic Lupus Erythematosus
Certain other autoimmune diseases and overlap syndromes
Sub-study for primary Sjgren's Syndrome
Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions
Sub-study for Rheumatoid Arthritis (RA)
Diagnosis with juvenile arthritis or idiopathic arthritis before age 16
For all sub-studies
History of any significant drug allergy
Active infection, significant concurrent medical condition, or clinically significant abnormalities
Other protocol defined inclusion/exclusion criteria could apply
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