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Trial information
A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNFalfa Therapy
Status: No longer recruiting
Protocol number: WA17042
Sponsor: Roche Products Ltd.; IDEC Pharmaceuticals Corporation
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 and inadequate response to methotrexate and anti-TNFa therapy
Brief summary: This study will compare the safety and efficacy of MabThera and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who have had an inadequate response to anti-tumor necrosis factor-alpha (anti-TNF@) therapy. The anticipated time on study treatment is up to 2 years, with repeat treatments provided under protocol WA17531, and the target sample size is 100-500 individuals.
Target sample size is 500.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; 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 Week 24, Change in DAS from screening to Week 24, Categorical DAS responders at Week 24, Changes from screening in ACR core set and SF-36
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 anti-TNF therapies;
- 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 disease-modifying antirheumatic drug (except for MTX) or any anti-TNFalfa factor or other biologic therapy;
- history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
- known contraindications to receiving MabThera;
- known active bacterial, viral, fungal, mycobacterial or other infection;
- women who are pregnant or breast-feeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: July, 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:Belgium Canada - Calgary, AB
- Edmonton, AB
- Vancouver, BC
- Hamilton, ON
- London, ON
- Toronto, ON
France - Le Kremlin-Bicetre
- Montpellier
- Paris
- Rouen
- Toulouse
Germany - Berlin
- Dresden
- Leipzig
- Ratingen
- Würzburg
Ireland Israel - Haifa
- Jerusalem
- Petah Tikva
- Ramat Gan
- Tel Aviv
Italy - Arenzano
- Brescia
- Genova
- Milano
- Pisa
- Udine
Netherlands Norway - Drammen
- Lillehammer
- Oslo
- Tromsø
United Kingdom - Cannock
- Leeds
- London
- Manchester
- Newcastle upon Tyne
- Wirral
United States - Birmingham, AL
- Paradise Valley, AZ
- Phoenix, AZ
- Tucson , AZ
- Little Rock, AR
- Fullerton, CA
- Los Angeles, CA
- Palo Alto, CA
- Pasadena, CA
- Rancho Mirage, CA
- Santa Maria, CA
- Upland, CA
- Danbury, CT
- Boca Raton, FL
- Delray Beach, FL
- Fort Lauderdale, FL
- Jupiter, FL
- Largo, FL
- Orlando, FL
- Boise, ID
- Coeur D'Alene, ID
- Meridan, ID
- Chicago, IL
- Indianapolis , IN
- Shreveport, LA
- Baltimore, MD
- Boston, MA
- Kalamazoo, MI
- Lansing, MI
- Rochester, MN
- St Louis, MO
- Albany, NY
- Manhasset, NY
- New York, NY
- Rochester, NY
- Smithtown, NY
- Chapel Hill, NC
- Durham, NC
- Greenville, NC
- Cincinnati, OH
- Dayton, OH
- Mayfield, OH
- Oklahoma City, OK
- Tulsa , OK
- Duncansville, PA
- Philadelphia, PA
- Amarillo, TX
- Dallas, TX
- Houston, TX
- Waco, TX
- Salt Lake City, UT
- Burlington, VT
- Seattle, WA
- Spokane , WA
- Madison, WI
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