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Trial information
A Study to Assess the Efficacy and Safety of Retreatment With MabThera (Rituximab) in Patients With Active Rheumatoid Arthritis (RA)
Status: No longer recruiting
Protocol number: WA16855
Sponsor: Roche Products Ltd.; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of MabThera retreatment on treatment response in patients with rheumatoid arthritis
Brief summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.
Target sample size is 470.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; 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 achieved by retreatment
Key secondary outcomes: 1. Efficacy: Time to reach an ACR50 or 70 response; proportion of patients with a EULAR response, or a DAS28 response
Safety: Adverse events, laboratory parameters
Inclusion criteria: - adult patients, >=21 years of age, with active RA;
- completed 24 weeks of treatment in WA16291 or WA17043;
- eligible for re-treatment, based on clinical symptoms;
- females of childbearing potential using reliable contraception.
Exclusion criteria: - patients who participated in MabThera studies WA16291 or WA17043 but withdrew into the safety follow-up phases of these trials;
- current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
- development of any new contraindications to receiving MabThera;
- female patients who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 21 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: August, 2002
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 - Maroochydore
- Melbourne
- Perth
Belgium Brazil - Campinas
- Curitiba
- Sao Paulo
Canada - Calgary, AB
- Vancouver, BC
- St John'S
Czech Republic Finland Germany - Köln
- Leipzig
- Ratingen
- Würzburg
Israel Italy - Genova
- Milano
- Modena
- Udine
Mexico - Guadalajara
- Mexico City
- Monterrey
New Zealand Poland - Bialystok
- Lublin
- Poznan
- Warszawa
- Wroclaw
Spain - La Laguna
- Madrid
- Merida
- Santiago de Compostela
- Sevilla
Sweden United Kingdom - Birmingham
- Cambridge
- Cannock
- Leeds
- Stoke-on-Trent
United States - Birmingham, AL
- Peoria, AZ
- Little Rock, AR
- La Jolla, CA
- Long Beach, CA
- Rancho Mirage, CA
- San Diego , CA
- Colorado Springs, CO
- Aventura, FL
- Boca Raton, FL
- Fort Lauderdale, FL
- Largo, FL
- Orlando, FL
- South Miami, FL
- Boise, ID
- Chicago, IL
- Indianapolis , IN
- Boston, MA
- Lansing, MI
- Minneapolis, MN
- St Louis, MO
- Lebanon, NH
- Voorhees, NJ
- Great Neck, NY
- Plainview, NY
- Rochester, NY
- Smithtown, NY
- Greenville, NC
- Winston-Salem, NC
- Beachwood, 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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