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Trial information
A Study of Ocrelizumab Given as a Single or Dual Infusion in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Status: Recruiting
Protocol number: WA20496
Sponsor: Hoffmann-La Roche; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A Randomised, Double-Blind study of the effect of Ocrelizumab Given as a Single Infusuion or a Dual Infusion Compared with Placebo on Signs and Symptoms in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to methotrexate therapy
Brief summary: This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1)infusions of ocrelizumab 200mg iv on days 1 and 15, 2) infusions of ocrelizumab 400mg iv on day 1 and placebo iv on day 15, or 3)infusions of placebo iv on days 1 and 15. At the end of the placebo-controlled treatment period, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week)throughout the study. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuas. In the US this trial is sponsored/managed by Genentech. Target sample size is 300.
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 ACR20 response Time frame: Week 24
Key secondary outcomes: 1. ACR50, ACR70, DAS28, Eular response rate, SF-36, FACIT-Fatigue score, comparison of AE rates after single and dual infusions of ocrelizumab Time frame: Weeks 24 and 48
2. AEs and lab parameters; PK and PD parameters after single and dual infusions of ocrelizumab Time frame: Throughout study
Inclusion criteria: - adult patients, >=18 years of age;
- active rheumatoid arthritis;
- inadequate treatment with any DMARD other than methotrexate.
Exclusion criteria: - rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- concurrent treatment with any DMARD other than methotrexate;
- previous treatment with any cell-depleting therapies;
- any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2008
Trial registration date: 04/15/2008
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:Argentina Australia Brazil - Brasilia
- Campinas
- Goiania
- Juiz De Fora
- Rio De Janeiro
- Sao Paulo
Canada - Calgary, AB
- Winnipeg, MB
- Hamilton, ON
- Ottawa, ON
Costa Rica France - Bordeaux
- Mulhouse
- Paris
- Toulouse
Germany - Berlin
- Frankfurt Am Main
- Heidelberg
- Köln
- Ludwigshafen
- Osnabrück
- Würzburg
Italy - Catania
- Coppito
- Ferrara
- Firenze
- Milano
- Roma
Mexico - Leon
- Morelia
- Saltillo
- Torreon
Poland Romania - Bucharest
- Cluj-Napoca
- Iasi
Spain - Las Palmas de Gran Canaria
- Madrid
- Malaga
Switzerland Thailand United Kingdom - Bridgend
- London
- Newcastle upon Tyne
- Northampton
- Salford
United States - Aniston, AL
- Peoria, AZ
- Little Rock, AR
- Huntington Beach, CA
- La Jolla, CA
- Long Beach, CA
- Palo Alto, CA
- San Diego , CA
- Santa Maria, CA
- Upland, CA
- Whittier, CA
- Colorado Springs, CO
- Bridgeport, CT
- Boca Raton, FL
- Fort Lauderdale, FL
- Jacksonville, FL
- Jupiter, FL
- Orlando, FL
- Palm Harbor, FL
- Pinellas Park, FL
- Tampa, FL
- Atlanta, GA
- Decatur, GA
- Macon , GA
- Marietta, GA
- Meridan, ID
- Evanston, IL
- Moline, IL
- Rockford, IL
- Indianapolis , IN
- Wichita, KS
- Bowling Green, KY
- Lexington, KY
- Cumberland, MD
- Frederick, MD
- Hagerstown, MD
- Kalamazoo, MI
- St. Clair Shores, MI
- Duluth, MN
- Eagan, MN
- Flowood, MS
- Tupelo, MS
- Florissant, MO
- Omaha, NE
- Las Cruces, NM
- Albany, NY
- Brooklyn, NY
- Orchard Park, NY
- Rochester, NY
- Belmont, NC
- Durham, NC
- Columbus, OH
- Dayton, OH
- Mayfield, OH
- Oklahoma City, OK
- Tulsa , OK
- Bethlehem, PA
- East Norriton, PA
- Philadelphia, PA
- Wexford, PA
- Columbia, SC
- Greenville, SC
- Hixson, TN
- Jackson, TN
- Memphis , TN
- Nashville, TN
- Amarillo, TX
- Austin, TX
- Dallas, TX
- Fort Worth, TX
- Houston, TX
- Lubbock, TX
- San Antonio, TX
- Waco, TX
- Arlington, VA
- Burke, VA
- Olympia, WA
- Spokane , WA
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