Trial information

A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis

Status: No longer recruiting

Protocol number: WA17823

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of safety and prevention of structural joint damage 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 respect to prevention of joint damage, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4mg iv, tocilizumab 8mg iv or placebo iv, every 4 weeks. All patients will also receive methotrexate, 10-25mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. Target sample size is 1170.

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. Change in modified Sharp total radiographic score and physical function Time frame: Week 52 and 104

Key secondary outcomes: 1. Percentage of patients with ACR 20/50/70 responses. Time frame: Week 24 2. Percentage of patients with ACR 70 maintained for 6 months Time frame: Week 24 3. Mean changes in parameters of ACR core set Time frame: Week 24 4. 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

Anticipated start date: January, 2005

Trial registration date: 07/26/2005

Date last updated: 11/21/2008

Link to trial result

This trial was conducted at the following locations:

Australia

• Adelaide
• Malvern
• Newcastle
• Shenton Park

Brazil

• Porto Alegre
• Rio De Janeiro
• Sao Paulo

China

• Beijing
• Nanjing
• Shanghai

Denmark

• Herlev
• Odense

Finland

• Heinola
• Helsinki

France

• Amiens
• Bobigny
• Bordeaux
• Le Kremlin-Bicetre
• Lille
• Nice
• Orleans
• Paris
• Rouen
• Strasbourg
• Toulouse
• Vandoeuvre-Les-Nancy

Greece

• Athens

Italy

• Brescia
• Coppito
• Firenze
• Genova
• Milano
• Napoli
• Padova
• Pavia
• Pisa
• Reggio Emilia
• Roma
• Torino
• Valeggio Sul Mincio
• Varese
• Verona

Mexico

• Chihuahua
• Mexico City
• Monterrey
• Obregon

Norway

• Lillehammer

Poland

• Bydgoszcz
• Dzialdowo
• Elblag
• Kalisz
• Krakow
• Poznan
• Szczecin
• Ustron
• Warszawa

South Africa

• Cape Town
• Soweto

Spain

• Barcelona
• Cádiz
• Merida
• Sabadell
• Santander
• Sevilla

United States

• Birmingham, AL
• Huntsville, AL
• Scottsdale, AZ
• Tucson , AZ
• Anaheim, CA
• Long Beach, CA
• Los Angeles, CA
• San Diego , CA
• Santa Maria, CA
• Torrance , CA
• Boulder, CO
• Denver, CO
• Aventura, FL
• Fort Lauderdale, FL
• Tampa, FL
• West Palm Beach, FL
• Boise, ID
• Coeur D'Alene, ID
• Idaho Falls, ID
• Meridan, ID
• Rockford, IL
• Lexington, KY
• Frederick, MD
• Hagerstown, MD
• Wheaton, MD
• Worcester, MA
• St Louis, MO
• Billings, MT
• Missoula, MT
• Dover, NH
• Medford, NJ
• Voorhees, NJ
• Albany, NY
• Brooklyn, NY
• Lake Success, NY
• New York, NY
• Asheville, NC
• Charlotte, NC
• Raleigh, NC
• Wilmington, NC
• Tulsa , OK
• Eugene, OR
• Bethlehem, PA
• Danville, PA
• Duncansville, PA
• West Reading, PA
• Ponce, PR
• San Juan, PR
• Columbia, SC
• Dallas, TX
• San Antonio, TX
• Olympia, WA
• Seattle, WA
• Glendale, WI