Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

• Status: Terminated
• Trial end date: 2018-05-30
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Mycophenolate mofetil; Mycophenolic Acid; Prednisone

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