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

This study has been completed.
Sponsor:
Information provided by:
Nuon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00882024
First received: April 14, 2009
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Active Rheumatoid Arthritis
Drug: Tranilast
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Nuon Therapeutics, Inc.:

Primary Outcome Measures:
  • Proportion of subjects who achieve of ACR20 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving ACR 50 and 70 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • EULAR responders (e.g. DAS28 good or moderate responders) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Mean change from baseline of each ACR component [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Assess the safety and tolerability of both doses of tranilast [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
Placebo tablets, bid, 12 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882024

  Show 32 Study Locations
Sponsors and Collaborators
Nuon Therapeutics, Inc.
Investigators
Study Director: Michael Kitt, MD Nuon Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Michael Kitt, MD/Chief Medical Officer, Nuon Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00882024     History of Changes
Other Study ID Numbers: A3003RA
Study First Received: April 14, 2009
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health

Keywords provided by Nuon Therapeutics, Inc.:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranilast
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Hematologic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents

ClinicalTrials.gov processed this record on October 23, 2014