Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Corticosteroids (prednisone or prednisolone); Drug: Abatacept; Drug: Mycophenolate mofetil (MMF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430677

IM101-075

Details and patient eligibility

About

The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.

Full description

Double Blind Period: Treatment, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, Active Control, Safety/Efficacy Study

Open Label Period: Prevention, Single Group Assignment, Open Label, Uncontrolled, Safety/Efficacy Study

Enrollment: 423 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
• Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria [2003], excluding Class III [C], IV-S [C] and IV-G [C], or the World Health Organization Class III or IV classification criteria [1982], excluding Class IIIc, IVd). If the renal biopsy was performed >3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA >upper limit of normal range.
• A stable serum creatinine ≤3 mg/dL

Exclusion criteria

• Subjects with a rise in serum creatinine of ≥1 mg/dL within 1 month prior to the screening visit
• Subjects with drug-induced SLE, as opposed to idiopathic SLE
• Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus
• Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [MS])
• Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
• Subjects who have received treatment with rituximab < 6 months prior to the screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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423 participants in 4 patient groups

Abatacept 30 mg/kg+Corticosteroids+MMF

Experimental group

Description:

Short-term Period

Treatment:

Drug: Abatacept

Drug: Abatacept

Drug: Corticosteroids (prednisone or prednisolone)

Drug: Abatacept

Drug: Mycophenolate mofetil (MMF)

Abatacept 10 mg/kg+Corticosteroids+MMF

Experimental group

Description:

Short-term Period

Treatment:

Drug: Abatacept

Drug: Abatacept

Drug: Corticosteroids (prednisone or prednisolone)

Drug: Abatacept

Drug: Mycophenolate mofetil (MMF)

Placebo+Corticosteroids+MMF

Experimental group

Description:

Short-term Period

Treatment:

Drug: Corticosteroids (prednisone or prednisolone)

Drug: Mycophenolate mofetil (MMF)

Abatacept 10mg/kg

Experimental group

Description:

Long-term Extension Period

Treatment:

Drug: Abatacept

Drug: Abatacept

Drug: Abatacept