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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882024

Enrollment

250

Registered

2009-04-16

Start date

2009-03-31

Completion date

2010-12-31

Last updated

2011-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

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.

Interventions

DRUGTranilast

150 mg tranilast tablets, bid, 12 weeks

DRUGPlacebo

Placebo tablets, bid, 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who achieve of ACR20 response	Week 12

Secondary

Measure	Time frame
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

Countries

Argentina, Bulgaria, Czechia, Germany, Mexico, Serbia, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026