Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Phase 3 Terminated 695 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

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)

Timeline

Start: 2013-01-22
Primary completion: 2016-11-21
Completion: 2018-05-30

Outcome

Missed primary endpoint

Stopped: “Inability to meet protocol objectives.”

registry Abatacept IV vs Placebo IV; p = 0.7264; Odds Ratio (OR) 1.08 (95% CI 0.7077 to 1.6421) NCT01714817 ↗

Publications

O'Connor SK, Devarajan P, Liu J, Maldonado MA, Sproles A, Rose J, Thornton S, Chen C, Huang B, Brunner HI. The Renal Activity Index for Lupus: Validation for Prediction of Kidney Inflammation in Adult Patients With Lupus Nephritis. J Rheumatol. 2026 Mar 1;53(3):283-291. doi: 10.3899/jrheum.2025-0504.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	10 mg/kg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1.5 g	Oral
Background	Prednisone	Other / unclassified	60 mg	Oral