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: 12/2/2008

Link to trial result

This trial was conducted at the following locations:

Argentina

• Buenos Aires

Australia

• Adelaide
• Maroochydore
• Shenton Park

Austria

• Wien

Brazil

• Porto Alegre
• Sao Paulo

Bulgaria

• Sofia
• Varna

Canada

• Calgary, AB
• Victoria, BC
• Winnipeg, MB
• St John'S
• Burlington, ON
• Newmarket, ON
• Ottawa, ON
• Toronto, ON
• Montreal, QC
• Sainte-Foy, QC

China

• Hong Kong
• Tuen Mun

France

• Besancon
• Creteil
• Le Mans
• Paris

Germany

• Bad Bramstedt
• Bad Nauheim
• Baden-Baden
• Berlin
• Erlangen
• Heidelberg
• Köln

Hungary

• Budapest
• Debrecen
• Pecs

Israel

• Beer Sheva
• Haifa
• Jerusalem
• Petah Tikva
• Tel Aviv

Italy

• Ferrara
• Gazzi
• Palermo
• Siena
• Udine

Mexico

• Chihuahua
• Guadalajara
• Mexico City
• San Luis Potosi

Singapore

• Singapore

Slovakia

• Piestany

Switzerland

• Bern
• Lausanne

Thailand

• Bangkok
• Chiang Mai