Trial information
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Status: Completed
Protocol number: WA17822
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of safety and reduction in signs and symptoms during treatment with tocilizumab versus placebo, in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis
Brief summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Target sample size is 630.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: tocilizumab
Primary outcome: 1. Percentage of patients with ACR 20 response Time frame: Week 24
Key secondary outcomes: 1. Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components. Time frame: Week 24
2. AEs, laboratory parameters, vital signs Time frame: Throughout study
Inclusion criteria:
- adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
- inadequate response to a stable dose of MTX;
- patients of reproductive potential must be using reliable methods of contraception.
Exclusion criteria:
- major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
- prior treatment failure with an anti-tumor necrosis factor agent;
- women who are pregnant or breast-feeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
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
- Montpellier
- 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
