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Therapeutic Areas: Immunology/Infectious Diseases | Musculoskeletal | Rheumatology | Nephrology/Urology
Disease Category: Systemic Lupus Erythematosus
Trial Information
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:
Interventional
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:
- male or female patients, >=16 years of age;
- diagnosis of systemic lupus erythematosus;
- WHO or ISN class III or IV active lupus nephritis.
Exclusion Criteria:
- severe renal impairment;
- previous treatment with a B cell directed therapy (other than one directed at BAFF).
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: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Scarborough, ON M1P 2V5
Canada
Phone: 973-235-5000 or 800-526-6367
View Google Map
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