MedTrace Logo

A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

NCT02097745 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2016-11-03

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

methotrexate

a 10-25 mg stable dose given orally or parenterally throughout study

DRUG

rituximab [MabThera/Rituxan]

1 g given by intravenous infusion on Days 1 and 15 of each treatment course

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • 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 NCT02097745 on ClinicalTrials.gov