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Completed

NCT Number: NCT00882024

Safety and Efficacy Study of Tranilast 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.

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Key information

Conditions

Active Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Capital Federal, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranilast

Drug

150 mg tranilast tablets, bid, 12 weeks

Placebo

Drug

Placebo tablets, bid, 12 weeks

Primary outcomes

  1. Proportion of subjects who achieve of ACR20 response

    Time frame: Week 12

Secondary outcomes

  1. Proportion of subjects achieving ACR 50 and 70 response

    Time frame: Week 12

  2. EULAR responders (e.g. DAS28 good or moderate responders)

    Time frame: week 12

  3. Mean change from baseline of each ACR component

    Time frame: weeks 2, 4, 8, 12 and 16

  4. Assess the safety and tolerability of both doses of tranilast

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Nuon Therapeutics, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2009
Registry last updated
Jan 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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