The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, 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. All subjects will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares
Systemic Lupus Erythematosus
Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- The primary objective of this study will be to assess the proportion of subjects with new clinical flare of SLE (BILAG “A” or “B”) [Time Frame: during the 1 year double-blind treatment period]
Secondary Outcome Measures:
- Assess proportion of subjects with a new clinical flare of SLE (BILAG A or B) [Time Frame: within the initial 6 months of the double-blind treatment period]
- Evaluate the proportion of subjects who experienced a BILAG A or B flare. [Time Frame: during the study]
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- Subjects 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.
- Stable dose of prednisone (<30mg) for at least one month.
- Subjects 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.
- Subjects with active viral or bacterial infections.
- Subjects with any other autoimmune disease as a main diagnosis.
- Prior treatment with rituximab.
- Cairns, Queensland, 4870, Australia
- Maroochydore, Queensland, 4558, Australia
- Malvern, Victoria, 3144, Australia
- Clayton, Victoria, 3168, Australia
- Heidelberg, Victoria, 3084, Australia
For more information, refer to Bristol-Myers Squibb Clinical Trials