Clinical trial NCT00882024: Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Active Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: Nuon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proportion of subjects who achieve of ACR20 response
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects achieving ACR 50 and 70 response
timeFrame: Week 12
measure: EULAR responders (e.g. DAS28 good or moderate responders)
timeFrame: week 12
measure: Mean change from baseline of each ACR component
timeFrame: weeks 2, 4, 8, 12 and 16
measure: Assess the safety and tolerability of both doses of tranilast
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Paradise Valley
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Frederick
country: United States
state: Maryland
city: Lansing
country: United States
state: Michigan
city: Hickory
country: United States
state: North Carolina
city: Duncansville
country: United States
state: Pennsylvania
city: Capital Federal
country: Argentina
state: Buenos Aires
city: Lujan
country: Argentina
state: Buenos Aires
city: Quilmes
country: Argentina
state: Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Brno-Bohunice
country: Czech Republic
city: Ostrava-Hlucin
country: Czech Republic
city: Praha
country: Czech Republic
city: Zlin
country: Czech Republic
city: Hamburg
country: Germany
city: Ludwigsfelde
country: Germany
city: Naumberg
country: Germany
city: Osnabruck
country: Germany
city: Ratingen
country: Germany
city: Wiesbaden
country: Germany
city: Mexicali
country: Mexico
state: Baja California
city: Guadalajara
country: Mexico
state: Jalisco
city: Morelia
country: Mexico
state: Michoacan
city: Obregon
country: Mexico
state: Sonora
city: Belgrade
country: Serbia
city: Niska Banja
country: Serbia
city: London
country: United Kingdom
Study officials:
affiliation: Nuon Therapeutics, Inc.
name: Michael Kitt, MD
role: STUDY_DIRECTOR
References: