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

January 5, 2011 updated by: Nuon Therapeutics, Inc.

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by ACR20 response at 12 weeks.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
      • Lujan, Buenos Aires, Argentina
      • Quilmes, Buenos Aires, Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina
  • Bulgaria
      • Plovdiv, Bulgaria
      • Sofia, Bulgaria
  • Czech Republic
      • Brno-Bohunice, Czech Republic
      • Ostrava-Hlucin, Czech Republic
      • Praha, Czech Republic
      • Zlin, Czech Republic
  • Germany
      • Hamburg, Germany
      • Ludwigsfelde, Germany
      • Naumberg, Germany
      • Osnabruck, Germany
      • Ratingen, Germany
      • Wiesbaden, Germany
  • Mexico
    • Baja California
      • Mexicali, Baja California, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
    • Michoacan
      • Morelia, Michoacan, Mexico
    • Sonora
      • Obregon, Sonora, Mexico
  • Serbia
      • Belgrade, Serbia
      • Niska Banja, Serbia
  • United Kingdom
      • London, United Kingdom
  • United States
    • Arizona
      • Mesa, Arizona, United States
      • Paradise Valley, Arizona, United States
    • California
      • La Jolla, California, United States
      • San Diego, California, United States
    • Florida
      • Aventura, Florida, United States
    • Maryland
      • Frederick, Maryland, United States
    • Michigan
      • Lansing, Michigan, United States
    • North Carolina
      • Hickory, North Carolina, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Receiving methotrexate
  • Have at least 8 painful/tender and 6 swollen joints
  • May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.

Exclusion Criteria:

  • Use of any anti-arthritic treatments except those allowed in inclusion criteria
  • Pregnant or nursing females
  • Abnormal laboratory values
  • History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence
  • Clinically significant systemic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo tablets, bid, 12 weeks
Experimental: 1 Tranilast
Tranilast, 300 mg/day
Drug: Tranilast
150 mg tranilast tablets, bid, 12 weeks
Drug: Tranilast
75 mg tablets, bid, 12 weeks
Experimental: 2 Tranilast
Tranilast, 150 mg/day
Drug: Tranilast
150 mg tranilast tablets, bid, 12 weeks
Drug: Tranilast
75 mg tablets, bid, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who achieve of ACR20 response
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving ACR 50 and 70 response
Time Frame: Week 12
Week 12
EULAR responders (e.g. DAS28 good or moderate responders)
Time Frame: week 12
week 12
Mean change from baseline of each ACR component
Time Frame: weeks 2, 4, 8, 12 and 16
weeks 2, 4, 8, 12 and 16
Assess the safety and tolerability of both doses of tranilast
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuon Therapeutics, Inc.

Investigators

  • Study Director: Michael Kitt, MD, Nuon Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 16, 2009

Study Record Updates

Last Update Posted (Estimate)

January 6, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3003RA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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