MedTrace Logo

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

NCT00106548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2010-06-11

No results posted yet for this study

Summary

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

tocilizumab [RoActemra/Actemra]

4mg/kg iv / month

DRUG

tocilizumab [RoActemra/Actemra]

8mg/kg iv / month

DRUG

Placebo

iv / month

DRUG

Methotrexate

10-25mg/week

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

Completion
2007-10-31

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • China
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Singapore
  • Slovakia
  • Switzerland
  • Thailand

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 NCT00106548 on ClinicalTrials.gov