Trial information
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 single arm 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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: tocilizumab
Primary outcome: 1. Efficacy: Concomitant corticosteroid treatment;proportion of patients with ACR20, ACR50 and ACR70 response; individual components of the ACR core set; withdrawals from treatment. Time frame: Every 12 weeks
2. Efficacy: Change in DAS28, categorical DAS responders; maintenance of ACR20, ACR50 and ACR70 response. Time frame: 24, 48, 96 and 264 weeks
Key secondary outcomes: 1. Quality of life: The HAQ, Short Form 36, EQ-5D and FACIT fatigue scale.
Time frame: Every 12 weeks
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 Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2005
Trial registration date: 12/12/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
Australia
- Adelaide
- Maroochydore
- Shenton Park
Austria
Brazil
Bulgaria
Canada
- Calgary, AB
- Victoria, BC
- Winnipeg, MB
- St John'S
- Burlington, ON
- Newmarket, ON
- Ottawa, ON
- Toronto, ON
- Montreal, QC
- Sainte-Foy, QC
China
France
- Besancon
- Creteil
- Le Mans
- Paris
Germany
- Bad Bramstedt
- Bad Nauheim
- Baden-Baden
- Berlin
- Erlangen
- Heidelberg
- Köln
Hungary
Israel
- Beer Sheva
- Haifa
- Jerusalem
- Petah Tikva
- Tel Aviv
Italy
- Ferrara
- Gazzi
- Palermo
- Siena
- Udine
Mexico
- Chihuahua
- Guadalajara
- Mexico City
- San Luis Potosi
Singapore
Slovakia
Switzerland
Thailand
