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An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy

NCT00883753 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 934

Last updated 2014-08-06

Study results available
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Summary

This study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.

Conditions

Interventions

DRUG

tocilizumab [RoActemra/Actemra]

8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Australia
  • Canada
  • Czechia
  • France
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Saudi Arabia
  • Spain
  • 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 NCT00883753 on ClinicalTrials.gov