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Trial information
A Study of Ocrelizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to anti-TNF-alpha Therapy.
Status: Recruiting
Protocol number: WA20495
Sponsor: Hoffmann-La Roche; 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 who have an inadequate response to at least one anti-TNF-alpha therapy.
Brief summary: This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15.A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.In the U.S. this trial 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 ACR20 response at week 24, and week 48.
Key secondary outcomes: 1. Efficacy: ACR50, ACR70, DAS28, EULAR response rate, modified Sharp score, HAQ-DI score, SF-36 and FACIT scores.
Inclusion criteria: - adult patients, >=18 years of age;
- rheumatoid arthritis for >=3 months;
- inadequate response to previous or current treatment with at least one anti-TNF-alpha agent;
- receiving either leflunomide or methotrexate for >=12 weeks, with a stable dose for the last 4 weeks.
Exclusion criteria: - rheumatic autoimmune disease or inflammatory joint disease, other than RA;
- any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 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 - Buenos Aires
- San Juan
- Tucuman
Australia - Maroochydore
- Shenton Park
- Woolloongabba
Belgium - Bruxelles
- Gent
- Leuven
- Merksem
- Montignies S/ Sambre
Brazil - Campinas
- Curitiba
- Goiania
- Porto Alegre
- Ribeirão Preto
- Rio De Janeiro
- Sao Paulo
Canada - Edmonton, AB
- Vancouver, BC
- Winnipeg, MB
- Burlington, ON
- Hamilton, ON
- Kitchener, ON
- London, ON
- Mississauga, ON
- Toronto, ON
- Montreal, QC
- Quebec City, QC
- Trois-Rivieres, QC
- Saskatoon, SK
Czech Republic France - Cahors
- Colmar
- Le Mans
- Lille
- Marseille
- Montpellier
- Nice
- Paris
- Rouen
Germany - Aachen
- Berlin
- Freiburg
- Giessen
- Heidelberg
- Köln
- Mainz
- München
- Osnabrück
- Würzburg
Hungary - Budapest
- Debrecen
- Szombathely
Israel - Beer Sheva
- Kfar Saba
- Petah Tikva
- Rishon Lezion
- Tel Aviv
Italy - Genova
- Pavia
- Pisa
- Reggio Emilia
Japan - Aomori
- Fukuoka
- Hiroshima
- Hokkaido
- Hyogo
- Nagasaki
- Osaka
- Saitama
- Shizuoka
- Tochigi
- Tokyo
Mexico - Guadalajara
- Mexicali
- Obregon
Netherlands New Zealand Panama Peru Poland - Bydgoszcz
- Elblag
- Szczecin
Slovakia Slovenia Spain - Badajoz
- Barcelona
- Bilbao
- Burgos
- Guadalajara
- Jerez De La Frontera
- La Coruna
- Madrid
- Oviedo
- Sabadell
- Salamanca
- Torrelavega
Sweden Switzerland Taiwan United States - Aniston, AL
- Birmingham, AL
- Huntsville, AL
- Tuscaloosa, AL
- Hot Springs, AZ
- Paradise Valley, AZ
- Phoenix, AZ
- Tucson , AZ
- Little Rock, AR
- La Jolla, CA
- Long Beach, CA
- Los Angeles, CA
- Palo Alto, CA
- San Diego , CA
- San Francisco, CA
- San Jose, CA
- San Leandro, CA
- Torrance , CA
- Whittier, CA
- Aurora, CO
- Colorado Springs, CO
- Denver, CO
- Camden, CT
- Danbury, CT
- Trumball, CT
- Waterbury, CT
- Lewes, DE
- Newark, DE
- Aventura, FL
- Jacksonville, FL
- Orlando, FL
- Palm Harbor, FL
- Sarasota , FL
- South Miami, FL
- Tampa, FL
- Zephyrhills, FL
- Atlanta, GA
- Cumming, GA
- Marietta, GA
- Boise, ID
- Coeur D'Alene, ID
- Meridan, ID
- Chicago, IL
- Evanston, IL
- Morton Grove, IL
- Rock Island, IL
- Springfield, IL
- Indianapolis , IN
- Munster, IN
- Cedar Rapids, IA
- Kansas City, KS
- Elizabethtown, KY
- Lexington, KY
- Louisville, KY
- Baton Rouge, LA
- Baltimore, MD
- Wheaton, MD
- Worcester, MA
- Ann Arbor, MI
- Kalamazoo, MI
- Lansing, MI
- St Clair Shores, MI
- Duluth, MN
- Eagan, MN
- Minneapolis, MN
- Flowood, MS
- Tupelo, MS
- Florissant, MO
- Richmond Heights, MO
- Springfield, MO
- St Louis, MO
- Omaha, NE
- Dover, NH
- Nashua, NH
- Haddon Heights, NJ
- Voorhees, NJ
- Albany, NY
- Brooklyn, NY
- Hewlett, NY
- New York, NY
- Olean, NY
- Rochester, NY
- Roslyn, NY
- Smithtown, NY
- Asheville, NC
- Belmont, NC
- Charlotte, NC
- Greenville, NC
- Hickory , NC
- Bismarck, ND
- Beachwood, OH
- Cincinnati, OH
- Dayton, OH
- Mayfield, OH
- Middleburg Heights, OH
- Oklahoma City, OK
- Tulsa , OK
- Bend, OR
- Eugene, OR
- Portland, OR
- Bethlehem, PA
- Erie, PA
- Philadelphia, PA
- West Reading, PA
- Wexford, PA
- Charleston, SC
- Simpsonville, SC
- Spartanburg, SC
- Jackson, TN
- Knoxville, TN
- Memphis , TN
- Amarillo, TX
- Austin, TX
- Dallas, TX
- El Paso, TX
- Lubbock, TX
- Mesquite, TX
- San Antonio, TX
- Sugarland, TX
- Salt Lake City, UT
- Arlington, VA
- Virginia Beach, VA
- Olympia, WA
- Seattle, WA
- Spokane , WA
- Tacoma, WA
- Vancouver , WA
- Yakima, WA
- Glendale, WI
- Onalaska, WI
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