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Trial information
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
Status: No longer recruiting
Protocol number: WA17045
Sponsor: Roche Products Ltd / Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study to evaluate the effect on treatment response of MabThera in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis
Brief summary: This study will evaluate the efficacy and safety of MabThera in patients with RA. Patients will be randomized to receive MabThera or placebo, and all patients will receive concomitant methotrexate, 10-25 mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is
500.
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. Proportion of patients with ACR20 response at Week 24.
Key secondary outcomes: 1. Efficacy: Proportion of patients with ACR50 and ACR70 response at Week 24; change in DAS28, ACR core set, SF36, and FACIT-F fatigue assessment from baseline to Week 24. EULAR response rates at Week 24. Safety: AEs,, lab parameters.
Inclusion criteria: - adult patients 18-80 years of age;
- RA for >=6 months;
- receiving outpatient treatment;
- inadequate response to methotrexate, having received and tolerated it for >=12 weeks.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: December, 2005
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:Canada - Hamilton, ON
- Kitchener, ON
- Saskatoon, SK
France Germany - Bad Aibling
- Berlin
- Erlangen
- Hildesheim
Guatemala Mexico - Aguascalientes
- Chihuahua
- Leon
- Morelia
- San Luis Potosi
Poland Romania Slovenia Sweden - Linkoeping
- Oskarstroem
- Uppsala
United Kingdom - Cannock
- Cardiff
- Harrogate
- Leeds
- Newcastle upon Tyne
- Southampton
- West Bromwich
- York
United States - Birmingham, AL
- Peoria, AZ
- Phoenix, AZ
- Little Rock, AR
- San Diego , CA
- Aurora, CO
- Colorado Springs, CO
- Hamden, CT
- Trumbull, CT
- Aventura, FL
- Boca Raton, FL
- Orlando, FL
- Sarasota , FL
- Vero Beach, FL
- West Palm Beach, FL
- Zephyrhills, FL
- Decatur, GA
- Meridan, ID
- Chicago, IL
- Rock Island, IL
- Springfield, IL
- Evansville, IN
- Indianapolis , IN
- Munster, IN
- Cedar Rapids, IA
- Kansas City, KS
- Bowling Green, KY
- Elizabethtown, KY
- Lexington, KY
- Louisville, KY
- Cumberland, MD
- Wheaton, MD
- Worcester, MA
- Kalamazoo, MI
- Cape Girardeau, MO
- St Louis, MO
- Omaha, NE
- Lebanon, NH
- Rochester, NY
- Cincinnati, OH
- Mayfield, OH
- Oklahoma City, OK
- Tulsa , OK
- Bend, OR
- Portland, OR
- Bethlehem, PA
- Philadelphia, PA
- West Reading, PA
- Willow Grove, PA
- Charleston, SC
- Simpsonville, SC
- Spartanburg, SC
- Jackson, TN
- Knoxville, TN
- Memphis , TN
- Amarillo, TX
- Dallas, TX
- Fort Worth, TX
- Salt Lake City, UT
- Everett, WA
- Seattle, WA
- Spokane , WA
- Tacoma, WA
- Vancouver , WA
- Onalaska, WI
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