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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Abatacept; Drug: Prednisone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00119678

IM101-042

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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183 participants in 3 patient groups, including a placebo group

Abatacept + Prednisone

Active Comparator group

Description:

Double Blind Period

Treatment:

Drug: Abatacept

Drug: Prednisone

Drug: Abatacept

Placebo + Prednisone

Placebo Comparator group

Description:

Double Blind Period

Treatment:

Drug: Prednisone

Drug: Placebo

Abatacept

Experimental group

Description:

Open Label

Treatment:

Drug: Abatacept

Drug: Abatacept