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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00882024
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : January 6, 2011
Information provided by:
Nuon Therapeutics, Inc.

April 14, 2009
April 16, 2009
January 6, 2011
March 2009
December 2010   (Final data collection date for primary outcome measure)
Proportion of subjects who achieve of ACR20 response [ Time Frame: Week 12 ]
Same as current
Complete list of historical versions of study NCT00882024 on ClinicalTrials.gov Archive Site
  • Proportion of subjects achieving ACR 50 and 70 response [ Time Frame: Week 12 ]
  • EULAR responders (e.g. DAS28 good or moderate responders) [ Time Frame: week 12 ]
  • Mean change from baseline of each ACR component [ Time Frame: weeks 2, 4, 8, 12 and 16 ]
  • Assess the safety and tolerability of both doses of tranilast [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Active Rheumatoid Arthritis
  • Drug: Tranilast
    150 mg tranilast tablets, bid, 12 weeks
  • Drug: Tranilast
    75 mg tablets, bid, 12 weeks
  • Drug: Placebo
    Placebo tablets, bid, 12 weeks
  • Experimental: 1 Tranilast
    Tranilast, 300 mg/day
    Intervention: Drug: Tranilast
  • Experimental: 2 Tranilast
    Tranilast, 150 mg/day
    Intervention: Drug: Tranilast
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Czech Republic,   Germany,   Mexico,   Serbia,   United Kingdom,   United States
Not Provided
Not Provided
Michael Kitt, MD/Chief Medical Officer, Nuon Therapeutics, Inc.
Nuon Therapeutics, Inc.
Not Provided
Study Director: Michael Kitt, MD Nuon Therapeutics, Inc.
Nuon Therapeutics, Inc.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP