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A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

NCT00810199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 556

Last updated 2014-07-18

Study results available
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Summary

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

Conditions

Interventions

DRUG

tocilizumab [RoActemra/Actemra]

tocilizumab 8 mg IV every 4 weeks.

DRUG

methotrexate

Approximately 15-17 mg methotrexate capsule orally once a week.

DRUG

placebo

Placebo matching methotrexate capsule taken orally once a week.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-08-31
Completion
2013-01-31

Countries

  • United States
  • Brazil
  • Croatia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Latvia
  • Netherlands
  • Norway
  • Romania
  • Russia
  • Serbia
  • Spain
  • Sweden
  • Thailand
  • United Kingdom

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 NCT00810199 on ClinicalTrials.gov