Trial information

A Study to Assess the Safety and Efficacy of Retreatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on anti-TNFalfa Therapy

Status: No longer recruiting

Protocol number: WA17531

Sponsor: Roche Products Ltd.; IDEC Pharmaceuticals Corporation

Company division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of MabThera retreatment on treatment response in patients with active rheumatoid arthritis and inadequate response to anti-TNF therapy

Brief summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals. Target sample size is 341.

Study phase: III

Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Rheumatoid Arthritis

Intervention type: Drug

Intervention name: rituximab[MabThera/Rituxan]

Primary outcome: 1. Efficacy: Proportion of patients with an ACR20 response

Key secondary outcomes: 1. Efficacy: Proportion of patients achieving an ACR50 and ACR70 response; proportion of patients with a EULAR response, or a DAS28 response Safety: Adverse events, laboratory parameters

Inclusion criteria:

• adult patients 18-80 years of age with active RA;
• patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
• eligible for re-treatment, based on clinical symptoms;
• patients of reproductive potential must be using reliable contraceptive methods.

Exclusion criteria:

• patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
• current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
• development of any new contraindications to receiving MabThera;
• women who are pregnant or breast-feeding.

Gender: Males or Females

Age limits: Min: 18 Years Max: 80 Years

Accepts healthy volunteers: No

Anticipated start date: March, 2004

Trial registration date: 07/26/2005

Date last updated: 11/21/2008

Link to trial result

This trial was conducted at the following locations:

Belgium

• Bruxelles
• Gent

Canada

• Calgary, AB
• Edmonton, AB
• Hamilton, ON
• London, ON
• Toronto, ON

France

• Le Kremlin-Bicetre
• Montpellier
• Paris
• Rouen
• Toulouse

Germany

• Berlin
• Dresden
• Leipzig
• Ratingen
• Würzburg

Ireland

• Cork

Israel

• Haifa
• Jerusalem
• Petah Tikva
• Ramat Gan
• Tel Aviv

Italy

• Brescia
• Pisa
• Udine

Netherlands

• Amsterdam

Norway

• Drammen
• Oslo

United Kingdom

• Cannock
• Leeds
• London
• Manchester
• Newcastle upon Tyne

United States

• Paradise Valley, AZ
• Phoenix, AZ
• Tucson , AZ
• Little Rock, AR
• Fullerton, CA
• Los Angeles, CA
• Pasadena, CA
• Rancho Mirage, CA
• Santa Maria, CA
• Boca Raton, FL
• Delray Beach, FL
• Fort Lauderdale, FL
• Jupiter, FL
• Orlando, FL
• Boise, ID
• Coeur D'Alene, ID
• Meridan, ID
• Chicago, IL
• Indianapolis , IN
• Shreveport, LA
• Baltimore, MD
• Boston, MA
• Kalamazoo, MI
• Lansing, MI
• Rochester, MN
• St Louis, MO
• Albany, NY
• Manhasset, NY
• New York, NY
• Rochester, NY
• Smithtown, NY
• Chapel Hill, NC
• Greenville, NC
• Cincinnati, OH
• Dayton, OH
• Mayfield, OH
• Oklahoma City, OK
• Tulsa , OK
• Duncansville, PA
• Philadelphia, PA
• Amarillo, TX
• Dallas, TX
• Houston, TX
• Waco, TX
• Salt Lake City, UT
• Burlington, VT
• Seattle, WA
• Spokane , WA
• Madison, WI