Trial information

SCORE Study: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate.

Status: Recruiting

Protocol number: MA21056

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (Mabthera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE stud

Brief summary: This 3 arm study will assess the efficacy of MabThera in the prevention of progression of structural joint damage in patients with active rheumatoid arthritis who have an inadequate clinical response to methotrexate. Patients will be randomized to receive MabThera 1000mg i.v., MabThera 500mg i.v. or placebo i.v. on days 1 and 15; all patients will receive concomitant methotrexate at a stable dosage of 12.5-25mg/week throughout the study. Further courses of MabThera will be provided to eligible patients. Structural joint damage will be assessed by magnetic resonance imaging (MRI) at baseline, and at intervals during the study. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 180.

Study phase: III

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

Condition: Rheumatoid Arthritis

Intervention type: Drug

Intervention name: rituximab [MabThera/Rituxan]

Primary outcome: 1. Changes in MRI bone erosion score from baseline Time frame: Week 24

Key secondary outcomes: 1. Change from baseline in MRI erosion, synovitis and osteitis Time frame: Week 12, 24 and 52 2. DAS 28-CRP, ACR 20/50/70, and HAQ. Time frame: Week 24 and 52 3. AEs, laboratory parameters, C-reactive protein, ESR. Time frame: Throughout study

Inclusion criteria:

• adult patients, 18-80 years of age;
• active rheumatoid arthritis for >=3 months and <=10 years;
• evidence of erosive disease and/or clinical synovitis in a signal joint;
• inadequate response to 12.5-25mg/week methotrexate for >=12 weeks.

Exclusion criteria:

• rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
• any surgical procedure within 12 weeks prior to baseline;
• previous treatment with a biologic agent or with a B cell modulating or cell depleting therapy.

Gender: Males or Females

Age limits: Min: 18 Years Max: 80 Years

Accepts healthy volunteers: No

Anticipated start date: November, 2007

Trial registration date: 12/19/2007

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Argentina

• Buenos Aires

Brazil

• Curitiba
• Goiania
• Porto Alegre
• Sao Paulo

Canada

• Winnipeg, MB
• St John'S
• Ottawa, ON
• Toronto, ON
• Montreal, QC
• Quebec City, QC
• Saskatoon, SK

Czech Republic

• Brno
• Ceské Budejovice
• Praha

Denmark

• Herlev
• Hvidovre
• København

Estonia

• Tallinn

France

• Montpellier
• Nice
• Orleans
• Toulouse

Germany

• Bad Aibling
• Berlin
• Dresden
• Erlangen
• Halle
• Hannover

Greece

• Athens
• Patras
• Thessaloniki

Latvia

• Riga

Lithuania

• Vilnius

Netherlands

• Amsterdam

Norway

• Oslo

Romania

• Bucharest
• Cluj-Napoca

Russian Federation

• Kazan
• Moscow
• St Petersburg
• Voronezh

Serbia and Montenegro

• Belgrade
• Niska Banja

Spain

• Barcelona
• Madrid
• Malaga
• San Sebastian
• Sevilla
• Valencia

Switzerland

• Bern

Turkey

• Adana
• Ankara
• Antalya
• Istanbul
• Izmir