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A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

NCT00965757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2021-12-17

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis

Conditions

Interventions

DRUG

T-614

T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.

DRUG

Placebo

Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.

Sponsors & Collaborators

  • FUJIFILM Toyama Chemical Co., Ltd.

    collaborator INDUSTRY

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kota Nagai · JAC PCU. EPCS, Eisai Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Japan

Study Locations

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Entities

Drugs
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 NCT00965757 on ClinicalTrials.gov