Status:
COMPLETED
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lupus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-93...
Detailed Description
1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period 2. The LTE period will remain blinded but will no longer have a placebo arm: * Subject...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Male or female aged between 18 to 70 (included)
- Diagnosed with active systemic lupus erythematosus by a doctor
- Disease must be in patient's joints or on the skin at a minimum
- Taking other medications is allowed but some are excluded
Exclusion
- Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
- Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
Key Trial Info
Start Date :
November 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
730 Patients enrolled
Trial Details
Trial ID
NCT02265744
Start Date
November 13 2014
End Date
November 30 2017
Last Update
October 7 2019
Active Locations (121)
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1
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States, 35801
2
St Jude Hospital Yorba Linda
Fullerton, California, United States, 92835
3
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
Long Beach, California, United States, 90806
4
Harbor UCLA Medical Center
Torrance, California, United States, 90509