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

Active Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882024
• Other study ID #: A3003RA
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2009
• Last updated: January 5, 2011
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Nuon Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Active Rheumatoid Arthritis
• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Tranilast
150 mg tranilast tablets, bid, 12 weeks
• Tranilast
75 mg tablets, bid, 12 weeks
• Placebo
Placebo tablets, bid, 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nuon Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Czech Republic,  Germany,  Mexico,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve of ACR20 response		Week 12	No
Secondary	Proportion of subjects achieving ACR 50 and 70 response		Week 12	No
Secondary	EULAR responders (e.g. DAS28 good or moderate responders)		week 12	No
Secondary	Mean change from baseline of each ACR component		weeks 2, 4, 8, 12 and 16	No
Secondary	Assess the safety and tolerability of both doses of tranilast		12 weeks	Yes