Trial Information

Summary: A Study of Tocilizumab in Patients Completing Treatment in WA17822

Status: No longer recruiting

Protocol Number: WA18695

Sponsor: Hoffmann-La Roche AG

Company Division: Pharmaceutical

Official Scientific Title: Long-term extension study of safety during treatment with tocilizumab in rheumatoid arthritis patients completing treatment in WA17822

Brief Summary: This study will evaluate the long-term efficacy and safety of tocilizumab in patients who have completed treatment in the tocilizumab WA17822 study of adults with rheumatoid arthritis. Patients will receive tocilizumab alone or in combination with standard anti-rheumatic treatment. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 630.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: tocilizumab

Primary Outcome: 1. Efficacy:concomitant corticosteroid treatment;withdrawals from treatment;ACR20,ACR50,and ACR70 response;individual components of the ACR core set;change in DAS28;categorical DAS responders Safety:AEs;clinical laboratory results;physical examination.

Key Secondary Outcomes: 1. Quality of life: The HAQ, Short Form 36, EQ-5D and FACIT fatigue scale.

Inclusion Criteria:

  • patients who have completed participation in the Phase III study WA17822 in adult rheumatoid arthritis.

Exclusion Criteria:

  • treatment with any investigational agent since the last administration of study drug in WA17822;
  • treatment with iv gammaglobulin, plasmapheresis or Prosorba column since the last administration of study drug in WA17822;
  • treatment with an anti-TNF of anti-IL1 agent, or a T cell costimulation modulator since the last administration of study drug in WA17822;
  • previous treatment with any cell-depleting therapies;
  • parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to baseline in WA18695.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2005

Trial Registration Date: 12/12/2005

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Maroochydore, Australia, 4558
Telephone: 973-235-5000 or 800-526-6367

  

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: May 13, 2008 at 1:47:43 PM


Back to Centerwatch Trial Listing by Location


Additional resources
in this illness area

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA