IFN4575g A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Ev

Project: Research project


Primary Objective
The primary objective of this study is to determine whether induction therapy with abatacept plus cyclophosphamide improves the response rate in patients with lupus nephritis compared with therapy with cyclophosphamide alone.

Secondary Objectives
Safety and Efficacy of Abatacept
• To gather safety information of abatacept in patients with lupus nephritis treated concurrently with cyclophosphamide.
• To assess response rates during prolonged treatment.
• To assess partial response rates.
Tolerance induction
This study will assess whether treatment with abatacept induces clinical tolerance (defined as “sustained remission after discontinuation of therapy”).3

The proposed study is a randomized, double-blind, controlled phase II multicenter trial in patients with lupus nephritis. The treatment group will receive abatacept 10 mg/kg/4 wk IV plus cyclophosphamide as defined by the Euro-Lupus Nephritis Trial: cyclophosphamide 500 mg IV q 2 wk x 6 followed by azathioprine 2 mg/kg/d PO (rounded up to nearest 25 mg and to a maximum dose of 200 mg).3, 43 Subjects randomized to the placebo group will receive cyclophosphamide/azathioprine alone (as described for the treatment group). All participants will receive a prednisone regimen as described in section 5.4. The primary endpoint will be assessed at 6 months. Thereafter, subsequent therapy will depend on the study group and the nature of the response during the first 6 months:
1. Participants in the treatment group who achieve a complete response at 6 months will discontinue study medication and commence azathioprine placebo to maintain blinding. Patients will be followed for 6 additional months to assess tolerance.
2. Participants in the control group who achieve a complete response at 6 months will continue azathioprine maintenance therapy.
3. Participants in either group who achieve a partial response at 6 months will continue study medication for 6 additional months.
4. Participants who have had no response at 6 months will conclude their participation in the study and will be treated according to their physician’s best clinical judgment. The blinded phase of the trial will conclude at 12 months; study treatment will discontinue at 12 months and further treatment will depend on local investigator preference. However, all patients who are still enrolled in the trial after 12 months will be re-evaluated at yearly intervals for 3 additional years to assess long-term clinical outcome and the durability of immunologic tolerance.
Effective start/end date1/28/106/30/14


  • Industry Sponsor


Lupus Nephritis
Multicenter Studies
Research Personnel
Control Groups