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Trial information
A Study of Ocrelizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate.
Status: Recruiting
Protocol number: WA20494
Sponsor: Hoffmann-La Roche Ltd; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of ocrelizumab, compared to placebo, on signs and symptoms in patients with active rheumatoid arthritis continuing methotrexate treatment.
Brief summary: This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg iv. or ocrelizumab 500mg iv. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive concomitant methotrexate 7.5mg - 25mg/week at a stable dose. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. In the U.S. this study is sponsored/managed by Genentech. Target sample size is
1000.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: ocrelizumab
Primary outcome: 1. Percentage of patients with ACR 20 response at week 24, and week 48.
Key secondary outcomes: 1. Efficacy: ACR50, ACR70, DAS28, EULAR response rate, modifed Sharp score, HAQ-DI score, SF-36 and FACIT scores. Safety: AEs, laboratory parameters.
Inclusion criteria: - adult patients, >=18 years of age;
- rheumatoid arthritis for >=3 months;
- inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for >=12 weeks.
Exclusion criteria: - rheumatic autoimmune disease or inflammatory joint disease, other than RA;
- prior receipt of any biologic therapy for RA;
- concurrent treatment with any DMARD (other than methotrexate).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2007
Trial registration date: 04/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:Argentina Australia - Maroochydore
- Shenton Park
Austria Belgium - Bruxelles
- Gent
- Merksem
- Montignies S/ Sambre
Brazil - Curitiba
- Goiania
- Porto Alegre
- Rio De Janeiro
- Sao Paulo
Canada - Vancouver, BC
- Victoria, BC
- Hamilton, ON
- Kitchener, ON
- London, ON
- Toronto, ON
- Sainte-Foy, QC
- Trois-Rivieres, QC
China France - Amiens
- Echirolles
- Marseille
- Montpellier
- Orleans
- Paris
Germany - Aachen
- Berlin
- Giessen
- Heidelberg
- München
- Osnabrück
- Würzburg
Greece - Athens
- Larissa
- Thessaloniki
Guatemala Israel - Ashkelon
- Haifa
- Ramat Gan
- Tel Aviv
Mexico - Aguascalientes
- Chihuahua
- Culiacan
- Guadalajara
- Mexicali
- Mexico City
- San Luis Potosi
New Zealand Panama Peru Russian Federation - Ekaterinburg
- Moscow
- Ryazan
- Saratov
- St Petersburg
- Tula
Spain - Castellon
- Gijon
- Merida
- Murcia
- Oviedo
- Santander
- Zaragoza
Taiwan - Kaohsiung
- Taichung
- Tainan
- Taoyuan
Thailand Ukraine United Kingdom - Cambridge
- Cannock
- Derby
- Dudley
- Liverpool
- London
- Sheffield
United States - Aniston, AL
- Birmingham, AL
- Huntsville, AL
- Montgomery, AL
- Tuscaloosa, AL
- Paradise Valley, AZ
- Peoria, AZ
- Phoenix, AZ
- Tucson , AZ
- Hot Springs, AR
- Jonesboro, AR
- Little Rock, AR
- Los Angeles, CA
- Northridge, CA
- Pasadena, CA
- San Diego , CA
- San Leandro, CA
- Upland, CA
- Colorado Springs, CO
- Denver, CO
- Newark, DE
- Washington, DC
- Aventura, FL
- Jacksonville, FL
- Largo, FL
- Orlando, FL
- Palm Harbor, FL
- Pinellas Park, FL
- Sarasota , FL
- South Miami, FL
- Tampa, FL
- Zephyrhills, FL
- Atlanta, GA
- Cumming, GA
- Rome, GA
- Coeur D'Alene, ID
- Idaho Falls, ID
- Meridan, ID
- Chicago, IL
- Morton Grove, IL
- Rock Island, IL
- Springfield, IL
- Indianapolis , IN
- Munster, IN
- Kansas City, KS
- Elizabethtown, KY
- Lexington, KY
- Louisville, KY
- Baton Rouge, LA
- Shreveport, LA
- Cumberland, MD
- Frederick, MD
- Worcester, MA
- Kalamazoo, MI
- Lansing, MI
- St Clair Shores, MI
- Duluth, MN
- Eagan, MN
- Minneapolis, MN
- St Cloud, MN
- Flowood, MS
- Florissant, MO
- Lees Summit, MO
- St Louis, MO
- Omaha, NE
- Reno , NV
- Lebanon, NH
- Haddon Heights, NJ
- New Brunswick, NJ
- Albany, NY
- Brooklyn, NY
- Lake Success, NY
- New York, NY
- Olean, NY
- Plainview, NY
- Rochester, NY
- Syracuse, NY
- Asheville, NC
- Belmont, NC
- Charlotte, NC
- Greenville, NC
- Beachwood, OH
- Canton, OH
- Cincinnati, OH
- Dayton, OH
- Mayfield, OH
- Oklahoma City, OK
- Tulsa , OK
- Bend, OR
- Eugene, OR
- Portland, OR
- Allentown, PA
- Bethlehem, PA
- Duncansville, PA
- West Reading, PA
- Charleston, SC
- Simpsonville, SC
- Jackson, TN
- Memphis , TN
- Nashville, TN
- Amarillo, TX
- Austin, TX
- Dallas, TX
- Houston, TX
- Lubbock, TX
- Mesquite, TX
- San Antonio, TX
- Waco, TX
- Ogden, UT
- Salt Lake City, UT
- Arlington, VA
- Everett, WA
- Olympia, WA
- Spokane , WA
- Tacoma, WA
- Vancouver , WA
- Yakima, WA
- Glendale, WI
- Onalaska, WI
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