Skip to main content
OpenTrials
Completed

NCT Number: NCT00144521

Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
  • Disease duration of 6 months or more
  • Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug
  • Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL

Exclusion criteria

  • Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug
  • Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug
  • Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.
  • Administration of any DMARD or immunosuppressant other than MTX
  • Administration of corticosteroids exceeding 10 mg/day as prednisolone
  • Dose escalation or initiation of corticosteroids
  • Received any of the following therapies in the 4 weeks preceding treatment with the study drug
  • Plasma exchange therapy
  • Surgical treatment (operation, etc.)

Treatment and study plan

MRA(Tocilizumab)

Drug

8mg/kg/4week(i.v.)for 24 weeks

MRA placebo

Drug

0mg/kg/4week(i.v.) for 24 weeks

MTX

Drug

8mg/week(p.o.) for 24 weeks

MTX Placebo

Drug

0mg/week(p.o.) for 24 weeks

Primary outcomes

  1. Frequency of ACR 20% improvement

    Time frame: week 24

Secondary outcomes

  1. Frequency and severity of adverse events and adverse drug reactions

    Time frame: throughout study

  2. Time course of DAS28

    Time frame: throughout study

  3. time course of the frequency of ACR 20%, 50% and 70%

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Important dates

Study start
2004
Primary completion
2004
Study completion
2006
First posted
Sep 5, 2005
Registry last updated
Feb 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.