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Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

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Wyeth

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo for 12 weeks
Drug: Methotrexate plus ERB-041 for 12 weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141830
3142A1-202
2005-001319-23 (EudraCT Number)
B2381010 (Other Identifier)

Details and patient eligibility

About

The primary objective of this study is to compare the efficacy and safety of 3 dose levels of oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of methotrexate (MTX).

Enrollment

159 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of active rheumatoid arthritis for at least 6 months and on a stable dose of methotrexate for at least 12 weeks
  • Rheumatoid arthritis onset after 16 years of age

Exclusion criteria

  • Any significant health problem other than rheumatoid arthritis
  • History of male or female reproductive system cancer
  • Clinically significant laboratory abnormalities

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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