Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Summary

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.

Timeline

Start

2007-06

Primary completion

2010-09

Completion

2011-08

Outcome

Missed primary endpoint

Stopped: “Terminated due to failure to meet the primary efficacy endpoint in the Short-term Period”

paper Although the primary end point was not met PMID 24504810 ↗

registry Abatacept 30/10 mg/kg vs Placebo; p = 0.746 NCT00430677 ↗

registry Abatacept 10/10 mg/kg vs Placebo; p = 0.118 NCT00430677 ↗

Publications

• Wolf BJ, Spainhour JC, Arthur JM, Janech MG, Petri M, Oates JC. Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol. 2016 Aug;68(8):1955-63. doi: 10.1002/art.39623.
• Furie R, Nicholls K, Cheng TT, Houssiau F, Burgos-Vargas R, Chen SL, Hillson JL, Meadows-Shropshire S, Kinaszczuk M, Merrill JT. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study. Arthritis Rheumatol. 2014 Feb;66(2):379-89. doi: 10.1002/art.38260.
• Wofsy D, Hillson JL, Diamond B. Comparison of alternative primary outcome measures for use in lupus nephritis clinical trials. Arthritis Rheum. 2013 Jun;65(6):1586-91. doi: 10.1002/art.37940.
• Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	10 mg/kg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1.5 g	Oral
Background	Mycophenolate Mofetil	Small molecule	2 g	Oral
Background	Prednisolone	Other / unclassified	0.5 mg/kg	Oral
Background	Prednisolone	Other / unclassified	0.8 mg/kg	Oral
Background	Prednisone	Other / unclassified	0.5 mg/kg	Oral
Background	Prednisone	Other / unclassified	0.8 mg/kg	Oral

Indications