Trial Information

Summary: An Extension Study of Tocilizumab in Patients Completing Treatment in Tocilizumab Core Studies

Status: No longer recruiting

Protocol Number: WA18696

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: Long-term extension study of safety during treatment with tocilizumab in rheumatoid arthritis patients completing treatment in tocilizumab core studies WA18062, WA18063 and WA17824

Brief Summary: This study will evaluate the long-term efficacy and safety of tocilizumab in patients who have completed treatment in the tocilizumab core studies 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 2068.

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: ACR20/50/70, change in DAS228, corticosteroid treatment, withdrawals, % patients switching from monotherapy to combination therapy. Safety: AEs, labs

Key Secondary Outcomes: 1. Quality of life: The HAQ, SF 36 and FACIT fatigue scale

Inclusion Criteria:

  • patients who have completed participation in one of the core studies in adult rheumatoid arthritis.

Exclusion Criteria:

  • treatment with any investigational agent since the last administration of study drug in core studies;
  • treatment with iv gamma globulin, plasmapheresis or prosorba column since the last administration of study drug in core studies;
  • treatment with an anti-TNF or anti-IL1 agent, or a T-cell costimulation modulator or any biologic since the last administration of study drug in core studies;
  • previous treatment with any cell-depleting therapies, including investigational agents;
  • parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to baseline in WA18696.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2005

Trial Registration Date: 12/12/2005

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Hobart, Australia, 7000
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 1:46:30 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