Trial information

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

Status: No longer recruiting

Protocol number: WA17044

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study to evaluate the effect of various re-treatment regimens of MabThera in combination with methotrexate on treatment response in rheumatoid arthritis patients with an inadequate response to methotrexate.

Brief summary: This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 375.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study

Condition: Rheumatoid Arthritis

Intervention type: Drug

Intervention name: rituximab [MabThera/Rituxan]

Primary outcome: Percentage of patients with an ACR 20 response. Timeframe: Week 48.

Key secondary outcomes: Proportion of patients with ACR 50 & ACR 70. Timeframe: Week 48. Change in DAS28, SF-36, FACIT-Fatigue assessment from baseline. Timeframe: Week 48. EULAR response rates. Timeframe: Week 48. AEs, laboratory parameters, & acute phase reactants. Timeframe: Throughout study.

Inclusion criteria:

• adult patients >=18 years of age;
• RA for >=6 months;
• receiving outpatient treatment;
• inadequate response to methotrexate, having received and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.

Exclusion criteria:

• rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
• inflammatory joint disease other than RA, or other systemic autoimmune disorder;
• diagnosis of juvenile arthritis, or RA before the age of 16;
• previous treatment with >1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: February, 2006

Trial registration date: 03/10/2006

Date last updated: 8/19/2008

Link to trial result

This trial was conducted at the following locations:

Australia

• Coffs Harbour
• Maroochydore
• Melbourne
• Sydney

Belgium

• Gent

Brazil

• Goiania
• Sao Paulo

Canada

• Penticton, BC
• Victoria, BC
• Winnipeg, MB
• London, ON
• Newmarket, ON
• Toronto, ON
• Trois-Rivieres, QC

China

• Beijing

Finland

• Oulu

France

• Bordeaux
• Le Mans
• Montpellier
• Nice
• Paris
• Rouen

Germany

• Bad Nauheim
• Hamburg
• Heidelberg
• Herne
• Köln
• Osnabrück
• Ratingen

Hungary

• Debrecen
• Eger

Italy

• Arenzano
• Coppito
• Ferrara
• Genova
• Palermo
• Pieve Di Coriano
• Pisa
• Prato
• Reggio Emilia
• Siena
• Torino
• Valeggio Sul Mincio

Netherlands

• Amsterdam

New Zealand

• Auckland
• Christchurch
• Timaru

Slovakia

• Kosice
• Piestany

South Africa

• Cape Town
• Pretoria
• Soweto

Spain

• Barcelona
• Gijon
• Leon
• Madrid
• Sevilla

Taiwan

• Kaohsiung
• Taichung
• Taoyuan

Thailand

• Bangkok
• Chiang Mai
• Khon Kaen

United Kingdom

• Birmingham
• Cambridge
• London
• Londonderry
• Middlesborough
• Northampton
• Nottingham
• Reading
• Truro
• Wigan
• Wirral