Trial information

A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Status: Completed

Protocol number: WA17824

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 monotherapy versus methotrexate monotherapy in patients with moderate to severe active rheumatoid arthritis

Brief summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 673.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Active; 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 20 response Time frame: Week 8 2. Percentage of patients with ACR 50 and ACR 70 responses Time frame: Week 24 3. Mean change 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 active RA for at least 3 months;
• 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 major surgery within 6 months after entering study;
• treatment with methotrexate (MTX) within 6 months of entering study;
• patients who have stopped previous MTX treatment due to toxicity or lack of response;
• 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: 8/29/2008

Link to trial result

This trial was conducted at the following locations:

Argentina

• Buenos Aires
• Rosario

Australia

• Hobart
• Shenton Park
• Sydney
• Woolloongabba

Canada

• Victoria, BC
• Winnipeg, MB
• St John'S
• Burlington, ON
• Hamilton, ON
• Kitchener, ON
• Mississauga, ON
• Ottawa, ON
• Sainte-Foy, QC

China

• Guangzhou
• Hefei Anhui
• Jinan

Denmark

• Herlev

France

• Brest
• Lyon
• Paris
• Rouen

Israel

• Ashkelon
• Haifa
• Rishon Lezion

Italy

• Genova
• Milano
• Pavia
• Reggio Emilia
• Siena

Lithuania

• Kaunas
• Klaipeda
• Panevezys
• Siauliai
• Vilnius

Mexico

• Guadalajara
• Mexico City

Norway

• Levanger
• Lillehammer

Peru

• Lima

Portugal

• Lisboa

Serbia and Montenegro

• Belgrade
• Niska Banja

Slovenia

• Ljubljana
• Maribor

South Africa

• Cape Town
• Pinelands
• Radiokop
• Soweto

Spain

• Barcelona
• Guadalajara
• La Laguna
• Santiago de Compostela

United States

• Paradise Valley, AZ
• Phoenix, AZ
• Little Rock, AR
• Long Beach, CA
• Los Angeles, CA
• Palm Springs, CA
• San Leandro, CA
• Santa Maria, CA
• Palm Harbor, FL
• Tampa, FL
• Idaho Falls, ID
• Meridan, ID
• Morton Grove, IL
• Springfield, IL
• Indianapolis , IN
• Cedar Rapids, IA
• Des Moines, IA
• Bowling Green, KY
• Slidell, LA
• Pittsfield, MA
• Grand Rapids, MI
• Kalamazoo, MI
• Lansing, MI
• Eagan, MN
• St Cloud, MN
• Flowood, MS
• Tupelo, MS
• St Louis, MO
• Dover, NH
• Haddon Heights, NJ
• New Brunswick, NJ
• Hickory , NC
• Oklahoma City, OK
• Tulsa , OK
• Duncansville, PA
• West Reading, PA
• Willow Grove, PA
• Charleston, SC
• Columbia, SC
• Greenville, SC
• Nashville, TN
• Amarillo, TX
• Austin, TX
• Mesquite, TX
• Chesapeake, VA
• Mountlake Terrace, WA
• Olympia, WA
• Spokane , WA