Trial information

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

Status: Completed

Protocol number: WA18063

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of tocilizumab on reduction in signs and symptoms in patients with moderate to severe active rheumatoid arthritis and inadequate response to DMARD therapy

Brief summary: This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 1205.

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 with ACR 50 and ACR 70 responses. Time frame: Week 24 2. Mean changes in parameters of ACR core set Time frame: Week 24 3. AEs, laboratory parameters, vital signs. Time frame: Throughout study

Inclusion criteria:

• 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 1 or more traditional DMARDs;
• stable DMARD therapy 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 entering study, or planned surgery within 6 months after entering study;
• patients who have previously failed treatment 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: 11/21/2008

Link to trial result

This trial was conducted at the following locations:

Argentina

• Buenos Aires
• Rosario

Australia

• Sydney

Brazil

• Campinas
• Goiania
• Rio De Janeiro

Canada

• Winnipeg, MB
• Hamilton, ON
• Ottawa, ON
• Quebec City, QC
• Saskatoon, SK

China

• Beijing
• Hong Kong
• Shanghai
• Tuen Mun

Costa Rica

• San José

Czech Republic

• Hradec Kralove
• Praha

Finland

• Helsinki
• Jyvaeskylae

France

• Boulogne-Billancourt
• Grenoble
• Marseille
• Montpellier
• Nantes
• Paris
• Pierre Benite
• Rennes
• Saint-Etienne

Germany

• Aachen
• Essen
• Hildesheim
• München
• Osnabrück
• Sendenhorst

Mexico

• Leon
• Mexico City
• Tijuana

Panama

• Panama City

Russian Federation

• Moscow
• Ryazan
• St Petersburg
• Tula

South Africa

• Durban
• Pretoria
• Radiokop

Spain

• Barakaldo
• Madrid
• Malaga
• Pontevedra
• Santiago de Compostela

Sweden

• Stockholm
• Umea

Thailand

• Bangkok
• Chiang Mai

United States

• Paradise Valley, AZ
• Peoria, AZ
• Phoenix, AZ
• Scottsdale, AZ
• Tucson , AZ
• Little Rock, AR
• Palm Desert, CA
• Palo Alto, CA
• San Jose, CA
• Upland, CA
• Newark, DE
• Washington, DC
• Delray Beach, FL
• Jupiter, FL
• Palm Harbor, FL
• Tampa, FL
• Springfield, IL
• Vernon Hills, IL
• Bowling Green, KY
• Baton Rouge, LA
• Shreveport, LA
• Frederick, MD
• Boston, MA
• Lansing, MI
• Eagan, MN
• Minneapolis, MN
• Springfield, MO
• St Louis, MO
• Lincoln, NE
• Reno , NV
• Haddon Heights, NJ
• New Brunswick, NJ
• Passaic, NJ
• Albuquerque, NM
• Plainview, NY
• Roslyn, NY
• Syracuse, NY
• Durham, NC
• Raleigh, NC
• Beachwood, OH
• Cincinnati, OH
• Dayton, OH
• Oklahoma City, OK
• Tulsa , OK
• Medford, OR
• Allentown, PA
• Bethlehem, PA
• Philadelphia, PA
• Pittsburgh, PA
• Willow Grove, PA
• Johnston, RI
• Charleston, SC
• Hixson, TN
• Nashville, TN
• Austin, TX
• Houston, TX
• Mesquite, TX
• Burlington, VT
• Spokane , WA
• Tacoma, WA
• La Crosse, WI
• Milwaukee, WI