Study Evaluating TMI-005 in Active Rheumatoid Arthritis

A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095342

Enrollment

390

Registered

2004-11-03

Start date

Unknown

Completion date

2005-08-31

Last updated

2009-09-10

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

Conditions

Rheumatoid Arthritis

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).

Interventions

DRUGTMI-005

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Countries

Canada, United States

Outcome results

None listed

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