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

Phase 2

Completed

• Conditions: Active Rheumatoid Arthritis
• Interventions: Drug: Tranilast; Drug: Placebo

• Registration Number: NCT00882024
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Tranilast	Tranilast	Tranilast, 300 mg/day
2 Tranilast	Tranilast	Tranilast, 150 mg/day
3	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve of ACR20 response	Week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving ACR 50 and 70 response	Week 12
EULAR responders (e.g. DAS28 good or moderate responders)	week 12
Mean change from baseline of each ACR component	weeks 2, 4, 8, 12 and 16
Assess the safety and tolerability of both doses of tranilast	12 weeks