NCT00882024

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Geographic Reach
8 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

1.8 years

First QC Date

April 14, 2009

Last Update Submit

January 5, 2011

Conditions

Active Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who achieve of ACR20 response

    Week 12

Secondary Outcomes (4)

  • 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

Study Arms (3)

1 Tranilast

EXPERIMENTAL

Tranilast, 300 mg/day

Drug: Tranilast

2 Tranilast

EXPERIMENTAL

Tranilast, 150 mg/day

Drug: Tranilast

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

TranilastDRUG

150 mg tranilast tablets, bid, 12 weeks

1 Tranilast
PlaceboDRUG

Placebo tablets, bid, 12 weeks

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving methotrexate
  • Have at least 8 painful/tender and 6 swollen joints
  • May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.

You may not qualify if:

  • Pregnant or nursing females
  • Abnormal laboratory values
  • History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence
  • Clinically significant systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Mesa, Arizona, United States

Location

Unknown Facility

Paradise Valley, Arizona, United States

Location

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Aventura, Florida, United States

Location

Unknown Facility

Frederick, Maryland, United States

Location

Unknown Facility

Lansing, Michigan, United States

Location

Unknown Facility

Hickory, North Carolina, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Capital Federal, Buenos Aires, Argentina

Location

Unknown Facility

Luján, Buenos Aires, Argentina

Location

Unknown Facility

Quilmes, Buenos Aires, Argentina

Location

Unknown Facility

Rosario, Santa Fe Province, Argentina

Location

Unknown Facility

Plovdiv, Bulgaria

Location

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Brno-Bohunice, Czechia

Location

Unknown Facility

Ostrava-Hlucin, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Zlín, Czechia

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Ludwigsfelde, Germany

Location

Unknown Facility

Naumburg, Germany

Location

Unknown Facility

Osnabrück, Germany

Location

Unknown Facility

Ratingen, Germany

Location

Unknown Facility

Wiesbaden, Germany

Location

Unknown Facility

Mexicali, Estado de Baja California, Mexico

Location

Unknown Facility

Guadalajara, Jalisco, Mexico

Location

Unknown Facility

Morelia, Michoacán, Mexico

Location

Unknown Facility

Obregón, Sonora, Mexico

Location

Unknown Facility

Belgrade, Serbia

Location

Unknown Facility

Niška Banja, Serbia

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tranilast

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michael Kitt, MD

    Nuon Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 16, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

AR(4)BU(2)DE(6)CZ(4)US(9)GB(1)ME(4)SE(2)