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Therapeutic Areas: Rheumatology | Musculoskeletal
Disease Category: Rheumatoid Arthritis
Trial Information
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 single arm 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: Concomitant corticosteroid treatment; proportion of patients with ACR20/50/70 response; individual components of the ACR core set; withdrawals from treatment. Time frame: Every 12 weeks
2. Change in DAS28; categorical DAS responders; maintenance of ACR20/50/70 response. Time frame: 24, 48, 96, 264 weeks.
Key Secondary Outcomes: 1. Quality of life: The HAQ, SF 36, EQ-5D, FACIT fatigue scale
Time frame: Every 12 weeks
2. Safety: AEs, laboratory parameters Time frame: Throughout study
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: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Shenton Park 6008
Australia
Phone: 973-235-5000 or 800-526-6367
View Google Map
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