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Trial information
A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate
Status: Recruiting
Protocol number: WA20497
Sponsor: Hoffmann-La Roche; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of ocrelizumab in combination with methotrexate, compared to methotrexate alone, on the treatment response in methotrexate-naive patients with active rheumatoid arthritis.
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 are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76.All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.In the US this study is sponsored/managed by Genentech, under protocol no. ACT3984g. Target sample size is 420.
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. Change from baseline in modified total Sharp score at week 52
Key secondary outcomes: 1. Efficacy:HAQ-DI, ACR20/50/70/90,DAS28,EULAR response rate, erosion score, JSN score,radiographic progression, SF-36, FACIT-F. Safety: AEs.lab parameters
Inclusion criteria: - adult patients, >=18 years of age;
- rheumatoid arthritis for 3 months-5 years;
- naive to methotrexate;
- if receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to baseline.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 06/15/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:Argentina Australia Austria Brazil - Curitiba
- Goiania
- Porto Alegre
- Sao Paulo
China Israel Italy - Catania
- Genova
- Jesi
- Messina
- Monserrato
- Napoli
- Pescara
- Reggio Emilia
- Roma
- Torino
- Trento
Lithuania - Kaunas
- Klaipeda
- Siauliai
- Vilnius
Mexico - Chihuahua
- Culiacan
- Guadalajara
- Mexicali
New Zealand Panama Peru Philippines Poland - Bialystok
- Bytom
- Dzialdowo
- Poznan
- Szczecin
- Ustron
- Warszawa
Russian Federation - Moscow
- Ryazan
- St Petersburg
South Africa Spain - Guadalajara
- La Laguna
- Leon
- San Sebastian
- Santiago de Compostela
- Sevilla
Switzerland Taiwan - Kaohsiung
- Taichung
- Tainan
- Taoyuan
Thailand United Kingdom - Barnsley
- Basingstoke
- Brighton
- Cambridge
- Huddersfield
- Liverpool
- London
- Manchester
- Newcastle upon Tyne
- Northampton
- Stoke-on-Trent
United States - Birmingham, AL
- Montgomery, AL
- Tuscaloosa, AL
- Paradise Valley, AZ
- Peoria, AZ
- Phoenix, AZ
- Tucson , AZ
- Jonesboro, AR
- Little Rock, AR
- Huntington Beach, CA
- Long Beach, CA
- Los Angeles, CA
- Pasadena, CA
- San Diego , CA
- San Leandro, CA
- Santa Maria, CA
- Upland, CA
- Hamden, CT
- Trumball, CT
- Newark, DE
- Boca Raton, FL
- Jacksonville, FL
- Jupiter, FL
- Palm Harbor, FL
- Sarasota , FL
- Tampa, FL
- Vero Beach, FL
- Zephyrhills, FL
- Atlanta, GA
- Idaho Falls, ID
- Chicago, IL
- Rock Island, IL
- Springfield, IL
- Indianapolis , IN
- Cedar Rapids, IA
- Bowling Green, KY
- Elizabethtown, KY
- Louisville, KY
- Shreveport, LA
- Portland, ME
- Cumberland, MD
- Ellicott City, MD
- Hagerstown, MD
- Wheaton, MD
- Worcester, MA
- Ann Arbor, MI
- Flint, MI
- Kalamazoo, MI
- Lansing, MI
- St. Clair Shores, MI
- Duluth, MN
- Eagan, MN
- Minneapolis, MN
- St Cloud, MN
- Flowood, MS
- Tupelo, MS
- Florissant, MO
- Kansas City, MO
- Lees Summit, MO
- Richmond Heights, MO
- St Louis, MO
- Billings, MT
- Lincoln, NE
- Las Vegas, NV
- Reno , NV
- New Brunswick, NJ
- Albuquerque, NM
- Brooklyn, NY
- Olean, NY
- Asheville, NC
- Belmont, NC
- Charlotte, NC
- Greenville, NC
- Hickory , NC
- Bismarck, ND
- Columbus, OH
- Mayfield, OH
- Middleburg Heights, OH
- Toledo, OH
- Oklahoma City, OK
- Tulsa , OK
- Portland, OR
- Bethlehem, PA
- Duncansville, PA
- Erie, PA
- Philadelphia, PA
- Pittsburgh, PA
- Wexford, PA
- Charleston, SC
- Columbia, SC
- Greenville, SC
- Jackson, TN
- Knoxville, TN
- Memphis , TN
- Amarillo, TX
- Austin, TX
- Dallas, TX
- El Paso, TX
- Fort Worth, TX
- Houston, TX
- Lubbock, TX
- San Antonio, TX
- Sugarland, TX
- Ogden, UT
- Yakima, WA
- Onalaska, WI
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