Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3

Conditions: Lupus Nephritis

Treatments: Biological: Placebo matching with BMS-188667; Biological: BMS-188667; Drug: Mycophenolate mofetil; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01714817

2012-000714-11 (EudraCT Number)

IM101-291

Details and patient eligibility

About

The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

Enrollment: 695 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Note: Subjects > 16 are eligible for enrollment at selected centers

Inclusion Criteria:

• Potential subjects must have active lupus nephritis

• Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney)

• Urine protein creatinine ratio (UPCR) ≥ 1 at Screening

• Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)

• There must also be evidence of active disease within 3 months of Screening, based on at least one of the following:

  • Worsening of lupus nephritis OR
  • UPCR ≥ 3 at Screening OR
  • Active urine sediment OR
  • Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis

Inclusion Criteria for the Long-Term Extension Period:

• Signed Written Informed Consent
• Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment

Exclusion Criteria:

• Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis
• Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study
• Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive
• Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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695 participants in 2 patient groups, including a placebo group

BMS-188667 + Mycophenolate mofetil + Prednisone

Experimental group

Description:

BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks

Treatment:

Drug: Prednisone

Drug: Mycophenolate mofetil

Biological: BMS-188667

Placebo + Mycophenolate mofetil + Prednisone

Placebo Comparator group

Description:

Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks

Treatment:

Drug: Prednisone

Drug: Mycophenolate mofetil

Biological: Placebo matching with BMS-188667