Trial Information

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

Status: Recruiting

Protocol Number: WA20499

Sponsor: Hoffmann-La Roche; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A Randomized, Double-Blind Study of the Effect of Ocrelizumab on Signs and Symptoms in Patients with Active 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 active, moderate to severe systemic lupus erythematosus. Patients will be randomized to receive ocrelizumab 1000mg i.v., ocrelizumab 400mg i.v. or placebo i.v. on days 1 and 15, and at week 16, 32 and 48. All patients will also receive standard of care immunosuppression and a standard steroid regimen. The anticipated time on study treatment is2+ years, and the target sample size is 100-500 individuals.In the US this study is sponsored/managed by Genentech. Target sample size is 423.

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. Proportions of patients at week 48 with 1) major clinical response 2) partial clinical response and 3) no clinical response assessed by BILAG.

Key Secondary Outcomes: 1. Safety: AEs and laboratory parameters, corticosteroid-sparing, frequency of disease flares. SLEDAI-2K and SDI. QoL: SF-36, FACIT fatigue and mBPI-SF.

Inclusion Criteria:

  • male or female patients, >=16 years of age;
  • diagnosis of systemic lupus erythematosus;
  • active disease at screening;
  • background use of AZA, MMF or MTX for >=60 days prior to baseline.

Exclusion Criteria:

  • active moderate to severe glomerulonephritis;
  • treatment with a second immunosuppressive or immunomodulatory drug in 8 weeks prior to baseline;
  • 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: December, 2007

Trial Registration Date: 11/14/2007

Date Last Updated: 10/28/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Philadelphia, PA 19111
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: November 17, 2008 at 2:37:49 PM


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