Study Evaluating TMI-005 in Active Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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TMI-005

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No