NCT00095342

Brief Summary

The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).

Trial Health

85
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Geographic Reach
2 countries

8 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

First Submitted

Initial submission to the registry

November 2, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

First QC Date

November 2, 2004

Last Update Submit

September 8, 2009

Conditions

Rheumatoid Arthritis

Interventions

TMI-005DRUG

Eligibility Criteria

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

You may qualify if:

  • Meet American College of Rheumatology (ACR) criteria for RA
  • Have active RA
  • Disease duration of at least 6 months
  • Disease onset at \> 16 years of age.

You may not qualify if:

  • Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra)
  • Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
  • Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Indianapolis, Indiana, 46250, United States

Location

Unknown Facility

Syracuse, New York, 13210, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

West Reading, Pennsylvania, 19611, United States

Location

Unknown Facility

Montreal, Quebec, H2L 1S6, Canada

Location

Unknown Facility

Ste-Foy, Quebec, G1W 4R4, Canada

Location

Unknown Facility

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

apratastat

Condition Hierarchy (Ancestors)

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

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 2004

First Posted

November 3, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

US(4)CA(4)