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

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.

Official Title

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

Conditions

Systemic Lupus Erythematosus

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further Details

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]

Study Start

September 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Total Enrolment

180

Contact Details

Australian Locations:

• 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