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A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

NCT00578305 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2015-04-10

Study results available
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Summary

This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.

Conditions

Interventions

BIOLOGICAL

Rituximab

Rituximab was supplied as a sterile liquid for iv administration.

DRUG

Placebo

Placebo was supplied as a sterile liquid in single-use vials for iv administration.

DRUG

Methylprednisolone

DRUG

Methotrexate

DRUG

Folic acid or folate

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-11-30
Completion
2013-05-31

Countries

  • Argentina
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Romania
  • Russia
  • Serbia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00578305 on ClinicalTrials.gov