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

NCT00422383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2015-05-04

Study results available
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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.

Conditions

Interventions

DRUG

rituximab [MabThera/Rituxan]

500mg iv in days 1 and 15, and 500mg iv on days 168 and 182

DRUG

rituximab [MabThera/Rituxan]

500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182

DRUG

rituximab [MabThera/Rituxan]

1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Slovakia
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00422383 on ClinicalTrials.gov