Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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: 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 (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Key facts

Study ID

NCT00119678

Run by

Bristol-Myers Squibb

People needed

183

Starts

2005-09-01

Expected to finish

2008-11-01

Last updated by the study team

2014-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Office Of Geoffrey S. Dolan, Md — Long Beach, California, United States
• 8737 Beverly Blvd. — Los Angeles, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Cria Research — Fort Lauderdale, Florida, United States
• The University Of Chicago — Chicago, Illinois, United States
• Kentuckiana Center For Better Bone And Joint Health — Louisville, Kentucky, United States
• Kelly, Timothy — Las Vegas, Nevada, United States
• Suny Downstate Medical Center — Brooklyn, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Ok Medical Research Foundations — Oklahoma City, Oklahoma, United States
• Texas Research Center — Sugarland, Texas, United States
• Local Institution — Cairns, Queensland, Australia
• Local Institution — Maroochydore, Queensland, Australia
• Local Institution — Clayton, Victoria, Australia
• Local Institution — Heidelberg, Victoria, Australia
• Local Institution — Malvern, Victoria, Australia
• Local Institution — Graz, Austria
• Local Institution — Brussels, Belgium
• Local Institution — Leuven, Belgium
• Local Institution — Goiânia, Goiás, Brazil
• Local Institution — Curitiba, Paraná, Brazil
• Local Institution — Rio de Janeiro - Rj, Rio de Janeiro, Brazil
• Local Institution — Campinas, São Paulo, Brazil
• Local Institution — São Paulo, São Paulo, Brazil
• University Of Arizona Arthritis Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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