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

Phase 2CompletedNCT00882024

Nuon Therapeutics, Inc.250 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Active Rheumatoid Arthritis

Interventions

TranilastDRUG

150 mg tranilast tablets, bid, 12 weeks

TranilastDRUG

75 mg tablets, bid, 12 weeks

PlaceboDRUG

Placebo tablets, bid, 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (32)

Unnamed facility

Mesa, Arizona, United States

Outcomes

Primary Outcomes

Proportion of subjects who achieve of ACR20 response

Time frame: Week 12

Secondary Outcomes

Proportion of subjects achieving ACR 50 and 70 response

Time frame: Week 12

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

Time frame: week 12

Mean change from baseline of each ACR component

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

Assess the safety and tolerability of both doses of tranilast

Time frame: 12 weeks

Data from ClinicalTrials.gov

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