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Trial information
A Study to Assess the Efficacy and Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis
Status: No longer recruiting
Protocol number: WA17043
Sponsor: Roche Products Ltd.; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of MabThera combined with methotrexate on treatment response in patients with active rheumatoid arthritis
Brief summary: This study will assess the efficacy and safety of different treatment regimens of MabThera, corticosteroids and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA). The anticipated time on study treatment is up to 2 years, with repeat treatments provided under protocol WA16855, and the target sample size is 100-500 individuals.
Target sample size is 440.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Efficacy:Proportion of patients with an ACR20 response at Week 24
Key secondary outcomes: 1. Efficacy: Proportion of patients with ACR(50,70) responses at Wk 24, Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
Safety: Adverse events, laboratory parameters
Inclusion criteria: - adult patients 18-80 years of age with active RA for >=6 months;
- inadequate response or intolerance to treatment with 1-5 disease modifying antirheumatic drugs (DMARDs) or biologics, other than MTX;
- receipt of MTX for >=12 weeks, with the last 4 weeks at a stable dose;
- active RA including at least 8 active joints and elevated acute phase reactants;
- patients of reproductive potential must be using reliable contraceptive methods.
Exclusion criteria: - functional RA Class IV;
- previous treatment with MabThera or other cell-depleting therapies;
- concurrent treatment with any DMARD (other than MTX) or any anti-tumor necrosis factor or other biologic therapy;
- history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
- known contraindications to receiving MabThera;
- known bacterial, viral, fungal, mycobacterial or other infection;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2003
Trial registration date: 07/26/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:Australia - Darlinghurst
- Maroochydore
- Melbourne
- Perth
Brazil - Campinas
- Curitiba
- Sao Paulo
Canada - Calgary, AB
- Vancouver, BC
- St John'S
- London, ON
Czech Republic Finland - Heinola
- Helsinki
- Jyvaeskylae
Germany - Köln
- Leipzig
- Ratingen
- Regensburg
- Würzburg
Italy - Ferrara
- Genova
- Milano
- Udine
Mexico - Guadalajara
- Mexico City
- Monterrey
New Zealand Poland - Bialystok
- Lublin
- Warszawa
- Wroclaw
Spain - La Laguna
- Madrid
- Merida
- Santiago de Compostela
- Sevilla
Sweden United Kingdom - Birmingham
- Cambridge
- Chertsey
- Leeds
- Stoke-on-Trent
United States - Birmingham, AL
- Peoria, AZ
- Little Rock, AR
- Long Beach, CA
- Los Angeles, CA
- Palm Desert, CA
- San Diego , CA
- Colorado Springs, CO
- Aventura, FL
- Boca Raton, FL
- Fort Lauderdale, FL
- Largo, FL
- Orlando, FL
- South Miami, FL
- Boise, ID
- Coeur D'Alene, ID
- Chicago, IL
- Indianapolis , IN
- Louisville, KY
- New Orleans, LA
- Slidell, LA
- Boston, MA
- Lansing, MI
- Minneapolis, MN
- St Louis, MO
- Lebanon, NH
- Voorhees, NJ
- Plainview, NY
- Rochester, NY
- Smithtown, NY
- Greenville, NC
- Winston-Salem, NC
- Beachwood, OH
- Cincinnati, OH
- Dayton, OH
- Mayfield, OH
- Tulsa , OK
- Portland, OR
- Duncansville, PA
- Dallas, TX
- Houston, TX
- Salt Lake City, UT
- Seattle, WA
- Glendale, WI
- Wausau, WI
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