Trial Information

Summary: A Study of Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus.

Status: Recruiting

Protocol Number: WA20500

Sponsor: Hoffmann-La Roche; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of ocrelizumab on renal response in patients with class III or IV nephritis due to systemic lupus erythematosus

Brief Summary: This 3 arm study will evaluate the efficacy and safety of 2 doses of ocrelizumab compared with placebo in patients with ISN/RPS or WHO class III or IV lupus nephritis. Patients will be randomized to receive ocrelizumab 1000mg iv, ocrelizumab 400mg iv or placebo iv on days 1 and 15, week 16 and every 16 weeks thereafter. All patients will also receive a standard immunosuppressant regimen of either mycopnenolate mofetil, or cyclophosphamide followed by azathioprine. All arms will also receive a standard steroid regimen. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.In the US this study is sponsored/managed by Genentech. Target sample size is 369.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Systemic Lupus Erythematosus

Intervention Type: Drug

Intervention Name: ocrelizumab

Primary Outcome: 1. Proportion of patients at week 48 with a Complete Renal Response, Partial Renal Response or no response, assessed by renal function, urinary sediment and proteinuria.

Key Secondary Outcomes: 1. Efficacy: BILAG, SLEDAI-2K. Safety: AEs and laboratory parameters. SDI. QoL: SF-36, FACIT fatigue, mBPI, Health Care Utilization.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 16 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2008

Trial Registration Date: 11/14/2007

Date Last Updated: 10/28/2008

Link To Trial Results

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Trial listings updated: December 2, 2008 at 3:14:36 PM