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Trial information
A Study of MabThera (Rituximab) in Combination With Methotrexate in Methotrexate-Naive Patients With Rheumatoid Arthritis (RA)
Status: No longer recruiting
Protocol number: WA17047
Sponsor: F Hoffman-La Roche Ltd; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of MabThera combined with methotrexate, compared with methotrexate monotherapy, on treatment response in methotrexate-naive patients with active rheumatoid arthritis
Brief summary: This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis, naive to methotrexate. Patients will be randomized to receive MabThera or placebo, and all patients will receive concomitant methotrexate, 7.5-20mg orally, once weekly. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 750.
Study phase: III
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. Change in total modified Sharp score at week 52
Key secondary outcomes: 1. Efficacy: Modified total Sharp score at wks 24 and 104,and Sharp erosion and JSN score at wk 52. % of patients without radiographic progression, and with ACR20/50/70/90, DAS28 at wk 52. HAQ-D1 and SF-36 at wks 52 and 104. Safety:AEs, lab parameters
Inclusion criteria: - adult patients 18-80 years of age;
- RA for >=2 months;
- receiving outpatient treatment;
- patients naive to, and considered to be candidates for, methotrexate treatment.
Exclusion criteria: - rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
- inflammatory joint disease other than RA, or other systemic autoimmune disorder;
- diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16;
- surgery within 12 weeks of study;
- previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy;
- concurrent treatment with any biologic agent or DMARD other than methotrexate.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: January, 2006
Trial registration date: 03/10/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:Australia Belgium Brazil - Brasilia
- Curitiba
- Goiania
- Sao Paulo
Canada - Calgary, AB
- Vancouver, BC
- St John'S
- Burlington, ON
- Ottawa, ON
- Toronto, ON
- Quebec City, QC
- Sherbrooke, QC
- Trois-Rivieres, QC
China Czech Republic Denmark Finland France - Corbeil-Essonnes
- Grenoble
- Le Kremlin-Bicetre
- Marseille
- Mulhouse
- Paris
- Strasbourg
- Toulouse
Germany - Bad Nauheim
- Berlin
- Essen
- Heidelberg
- Herne
- Köln
- Leipzig
- Osnabrück
- Ratingen
- Regensburg
- Würzburg
Guatemala India - Chandigarh
- Hyderabad
- Lucknow
- Vellore
Italy - Bergamo
- Firenze
- Milano
- Pavia
- Prato
- Reggio Emilia
- Roma
- Udine
- Verona
Korea, Republic of Mexico - Chihuahua
- Culiacan
- Guadalajara
- Mexicali
- Mexico City
- Obregon
- Tijuana
Netherlands Norway Panama Peru Philippines Poland - Bydgoszcz
- Elblag
- Katowice
- Warszawa
- Wroclaw
Romania Russian Federation Spain - Barakaldo
- Barcelona
- Guadalajara
- La Coruna
- Las Palmas de Gran Canaria
- Madrid
- Oviedo
- Santiago de Compostela
- Sevilla
Sweden United Kingdom - Aberdeen
- Bridgend
- Cambridge
- London
- Maidstone
- Newcastle upon Tyne
- Poole
- Reading
United States - Aniston, AL
- Birmingham, AL
- Tuscaloosa, AL
- Peoria, AZ
- Tucson , AZ
- Little Rock, AR
- La Jolla, CA
- Long Beach, CA
- Los Angeles, CA
- Palm Desert, CA
- San Diego , CA
- Upland, CA
- Aventura, FL
- Delray Beach, FL
- Dunedin, FL
- Jupiter, FL
- Largo, FL
- Palm Harbor, FL
- Sarasota , FL
- Tampa, FL
- Atlanta, GA
- Idaho Falls, ID
- Chicago, IL
- Springfield, IL
- Bowling Green, KY
- Elizabethtown, KY
- Louisville, KY
- Shreveport, LA
- Slidell, LA
- Boston, MA
- Worcester, MA
- East Lansing, MI
- Minneapolis, MN
- St Cloud, MN
- Florissant, MO
- Reno , NV
- Lebanon, NH
- Asheville, NC
- Charlotte, NC
- Columbus, OH
- Oklahoma City, OK
- Tulsa , OK
- Bethlehem, PA
- Duncansville, PA
- Greenville, SC
- Spartanburg, SC
- Jackson, TN
- Knoxville, TN
- Amarillo, TX
- Dallas, TX
- Lubbock, TX
- San Antonio, TX
- Seattle, WA
- Yakima, WA
- Onalaska, WI
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