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Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)

NCT00882024 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2011-01-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active RA when added to continuing methotrexate (MTX) therapy.

Conditions

  • Active Rheumatoid Arthritis

Interventions

DRUG

Tranilast

150 mg tranilast tablets, bid, 12 weeks

DRUG

Tranilast

75 mg tablets, bid, 12 weeks

DRUG

Placebo

Placebo tablets, bid, 12 weeks

Sponsors & Collaborators

  • Nuon Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kitt, MD · Nuon Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Czechia
  • Germany
  • Mexico
  • Serbia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00882024 on ClinicalTrials.gov