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: 9/29/2008

Link to trial result

This trial is being conducted at the following locations:

Argentina

• Buenos Aires
• Tucuman

Australia

• Campsie
• Malvern

Brazil

• Brasilia
• Campinas
• Goiania
• Juiz De Fora
• Rio De Janeiro
• Sao Paulo

Canada

• Calgary, AB
• Winnipeg, MB
• Hamilton, ON
• Ottawa, ON

France

• Bordeaux
• Mulhouse
• Paris
• Toulouse

Germany

• Frankfurt Am Main
• Heidelberg
• Köln
• Ludwigshafen
• Osnabrück

Italy

• Catania
• Coppito
• Ferrara
• Firenze
• Roma

Mexico

• Leon
• Morelia
• Saltillo
• Torreon

Poland

• Lublin
• Poznan
• Szczecin

Romania

• Bucharest
• Cluj-Napoca
• Iasi

Spain

• Las Palmas de Gran Canaria
• Madrid
• Malaga

Switzerland

• Lausanne

Thailand

• Bangkok

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
• Rock Island, 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