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

Primary Purpose

Active Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tranilast
Tranilast
Placebo
Sponsored by
Nuon Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Rheumatoid Arthritis focused on measuring Rheumatoid arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1 Tranilast

2 Tranilast

3

Arm Description

Tranilast, 300 mg/day

Tranilast, 150 mg/day

Placebo

Outcomes

Primary Outcome Measures

Proportion of subjects who achieve of ACR20 response

Secondary Outcome Measures

Proportion of subjects achieving ACR 50 and 70 response
EULAR responders (e.g. DAS28 good or moderate responders)
Mean change from baseline of each ACR component
Assess the safety and tolerability of both doses of tranilast

Full Information

First Posted
April 14, 2009
Last Updated
January 5, 2011
Sponsor
Nuon Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00882024
Brief Title
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nuon Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Rheumatoid Arthritis
Keywords
Rheumatoid arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 Tranilast
Arm Type
Experimental
Arm Description
Tranilast, 300 mg/day
Arm Title
2 Tranilast
Arm Type
Experimental
Arm Description
Tranilast, 150 mg/day
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tranilast
Intervention Description
150 mg tranilast tablets, bid, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Tranilast
Intervention Description
75 mg tablets, bid, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets, bid, 12 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve of ACR20 response
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving ACR 50 and 70 response
Time Frame
Week 12
Title
EULAR responders (e.g. DAS28 good or moderate responders)
Time Frame
week 12
Title
Mean change from baseline of each ACR component
Time Frame
weeks 2, 4, 8, 12 and 16
Title
Assess the safety and tolerability of both doses of tranilast
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kitt, MD
Organizational Affiliation
Nuon Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
Mesa
State/Province
Arizona
Country
United States
City
Paradise Valley
State/Province
Arizona
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Frederick
State/Province
Maryland
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Capital Federal
State/Province
Buenos Aires
Country
Argentina
City
Lujan
State/Province
Buenos Aires
Country
Argentina
City
Quilmes
State/Province
Buenos Aires
Country
Argentina
City
Rosario
State/Province
Santa Fe
Country
Argentina
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
State/Province
Baja California
Country
Mexico
City
Guadalajara
State/Province
Jalisco
Country
Mexico
City
Morelia
State/Province
Michoacan
Country
Mexico
City
Obregon
State/Province
Sonora
Country
Mexico
City
Belgrade
Country
Serbia
City
Niska Banja
Country
Serbia
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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