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Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis - IM014-029

Updated: 5 October, 2020   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-65

    Age Range

  • 65

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: pSS: branebrutinib
Drug: branebrutinib
Placebo Comparator: pSS: placebo
Drug: branebrutinib placebo
Experimental: RA: branebrutinib followed by abatacept
Drug: abatacept Drug: branebrutinib
Placebo Comparator: RA: placebo followed by abatacept
Drug: branebrutinib placebo Drug: abatacept
Experimental: SLE: branebrutinib
Drug: branebrutinib
Placebo Comparator: SLE: placebo
Drug: branebrutinib placebo

Key Eligibility Criteria

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. 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 Sjögren'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 Sjögren'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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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