Study Evaluating TMI-005 in Active Rheumatoid Arthritis

Wyeth

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: TMI-005

Study type

Interventional

Funder types

Industry

Identifiers

NCT00095342

3140A1-200

Details and patient eligibility

About

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).

Enrollment

390 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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