Trial information

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy

Status: Completed

Protocol number: WA18062

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 active rheumatoid arthritis and inadequate response to anti-TNF therapy

Brief summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 450.

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 2. AEs, laboratory parameters, vital signs, ECGs. Time frame: Throughout study

Key secondary outcomes: 1. Percentage of patients with ACR 50 and ACR 70 responses Time frame: Week 24 2. Mean changes in parameters of ACR core set Time frame: Week 24

Inclusion criteria:

• adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
• inadequate response to current anti-rheumatic therapies, including MTX;
• inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
• on stable MTX for at least 8 weeks before entering study;
• patients of reproductive potential must be using reliable methods of contraception.

Exclusion criteria:

• major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
• 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:

Australia

• Malvern
• Shenton Park

Belgium

• Hasselt
• Merksem

Canada

• Calgary, AB
• Edmonton, AB
• Winnipeg, MB
• Kitchener, ON
• London, ON
• Mississauga, ON
• Toronto, ON
• Montreal, QC
• Sainte-Foy, QC

France

• Amiens
• Bordeaux
• Le Kremlin-Bicetre
• Lille
• Nice
• Paris
• Strasbourg
• Toulouse

Germany

• Berlin
• Dresden
• Herne
• Köln
• München
• Vogelsang-Gommern
• Wiesbaden
• Würzburg

Iceland

• Reykjavik

Italy

• Brescia
• Milano
• Padova
• Pavia
• Pisa
• Udine

Mexico

• Guadalajara

Netherlands

• Enschede
• Nijmegen

Sweden

• Stockholm

Switzerland

• Lausanne

United Kingdom

• Basingstoke
• Birmingham
• Cannock
• Derby
• Leeds
• London
• Manchester
• Middlesborough
• Newcastle upon Tyne
• Oxford
• Southampton
• Stoke-on-Trent

United States

• Birmingham, AL
• Huntsville, AL
• Scottsdale, AZ
• Tucson , AZ
• Anaheim, CA
• Long Beach, CA
• Los Angeles, CA
• Palm Desert, CA
• San Diego , CA
• Santa Maria, CA
• Torrance , CA
• Aurora, CO
• Colorado Springs, CO
• Aventura, FL
• Fort Lauderdale, FL
• Palm Harbor, FL
• Sarasota , FL
• Tampa, FL
• West Palm Beach, FL
• Atlanta, GA
• Boise, ID
• Meridan, ID
• Chicago, IL
• Bowling Green, KY
• Lexington, KY
• Louisville, KY
• Portland, ME
• Baltimore, MD
• Wheaton, MD
• Worcester, MA
• Tupelo, MS
• St Louis, MO
• Billings, MT
• Albany, NY
• Binghamton, NY
• Lake Success, NY
• New York, NY
• Orchard Park, NY
• Rochester, NY
• Asheville, NC
• Chapel Hill, NC
• Charlotte, NC
• Hickory , NC
• Bismarck, ND
• Canton, OH
• Cincinnati, OH
• Oklahoma City, OK
• Tulsa , OK
• Eugene, OR
• Danville, PA
• Duncansville, PA
• Ponce, PR
• Jackson, TN
• Austin, TX
• Dallas, TX
• Houston, TX
• Norfolk , VA
• Seattle, WA
• Glendale, WI