Status:
COMPLETED
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems:...
Eligibility Criteria
Inclusion
- participants must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit (arthritis)
- Stable dose of prednisone (\<30mg) for at least one month
Exclusion
- participants experiencing an active lupus flare in the kidney or central nervous systems
- Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study
- participants with active viral or bacterial infections
- participants with any other autoimmune disease as a main diagnosis
- Prior treatment with rituximab
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT00119678
Start Date
September 1 2005
End Date
November 1 2008
Last Update
September 22 2014
Active Locations (52)
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1
University Of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
2
Office Of Geoffrey S. Dolan, Md
Long Beach, California, United States, 90808
3
8737 Beverly Blvd.
Los Angeles, California, United States, 90048
4
Denver Arthritis Clinic
Denver, Colorado, United States, 80230