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Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis

NCT00760864 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2010-06-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of TAK-715, twice daily (BID), in the treatment of rheumatoid arthritis signs and symptoms in patients with a partial response to methotrexate.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

TAK-715 and methotrexate

TAK-715 25 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.

DRUG

TAK-715 and methotrexate

TAK-715 50 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.

DRUG

TAK-715 and methotrexate

TAK-715 100 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.

DRUG

Methotrexate

TAK-715 placebo-matching, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks

Sponsors & Collaborators

Principal Investigators

  • VP Biological Sciences · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-09-30
Completion
2005-09-30

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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 NCT00760864 on ClinicalTrials.gov