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

NCT00144521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2009-02-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

MRA(Tocilizumab)

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

DRUG

MRA placebo

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

DRUG

MTX

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

DRUG

MTX placebo

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

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Takahiro Kakehi · Chugai Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2004-08-31
Completion
2006-04-30

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Entities

Diseases

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 NCT00144521 on ClinicalTrials.gov