Trial Information

Summary: A Study of Ocrelizumab in Patients With Rheumatoid Arthritis.

Status: No longer recruiting

Protocol Number: WA18230

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind, dose-escalating study of the effect of a single dose of ocrelizumab on treatment response in patients with moderate to severe rheumatoid arthritis with unsatisfactory response to stable doses of concomitant methotrexate

Brief Summary: This study will evaluate the safety, tolerability and efficacy of ocrelizumab compared with placebo in combination with methotrexate in patients with moderate to severe rheumatoid arthritis (RA). The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals. Target sample size is 160.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: ocrelizumab

Primary Outcome: 1. Safety: Adverse events,laboratory parameters, immunology

Key Secondary Outcomes: 1. Efficacy: Percentage of patients with clinical response (ACR) of 20%, 50%, and 70%, disease activity score and proportion of EULAR responders

Inclusion Criteria:

  • adult patients 18-80 years of age;
  • RA for >=6 months;
  • treatment failure with >=1 but <=5 drugs, other than methotrexate;
  • current treatment with methotrexate for at least 12 weeks, at a stable dose.

Exclusion Criteria:

  • rheumatic autoimmune disease or inflammatory joint disease, other than RA;
  • previous treatment with rituximab;
  • concurrent treatment with any DMARD (other than methotrexate) or any anti-TNF-a or other biologic therapy.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2005

Trial Registration Date: 07/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Perth, Australia, 6000
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 22, 2008 at 2:51:48 PM


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