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Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

NCT01258712 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2012-12-13

No results posted yet for this study

Summary

This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

Tocilizumab + methotrexate(MTX)

Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week

DRUG

Tocilizumab placebo + methotrexate(MTX)

Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week

Sponsors & Collaborators

  • Chugai Pharma Taiwan

    lead INDUSTRY

Principal Investigators

  • Yoshiaki Someya · Chugai Pharma Taiwan

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
2010-12-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Taiwan

Study Locations

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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 NCT01258712 on ClinicalTrials.gov