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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. Identifier: NCT00882024
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : January 6, 2011
Information provided by:
Nuon Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Active Rheumatoid Arthritis Drug: Tranilast Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Tranilast
Tranilast, 300 mg/day
Drug: Tranilast
150 mg tranilast tablets, bid, 12 weeks

Experimental: 2 Tranilast
Tranilast, 150 mg/day
Drug: Tranilast
75 mg tablets, bid, 12 weeks

Placebo Comparator: 3
Drug: Placebo
Placebo tablets, bid, 12 weeks

Primary Outcome Measures :
  1. Proportion of subjects who achieve of ACR20 response [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00882024

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

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Responsible Party: Michael Kitt, MD/Chief Medical Officer, Nuon Therapeutics, Inc. Identifier: NCT00882024    
Other Study ID Numbers: A3003RA
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011
Keywords provided by Nuon Therapeutics, Inc.:
Rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Platelet Aggregation Inhibitors
Anti-Allergic Agents