Official Title: “An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity”

To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Drug: etanercept (EnbrelTM)
• Drug: methotrexate
• Drug: disease-modifying anti-rheumatic drug (DMARDs) (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• To evaluate the impact of ETN + MTX in comparison with usual treatment on radiographic disease progression in subject with moderate RA, who failed treatment with MTX
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Secondary Measures

• To compare the effects of ETN + MTX and usual treatment on clinical outcomes , health-related quality of life, and safety
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
• Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
• Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

• Previous treatment with ETN, infliximab, adalimumab, other TNF -a inhibitors, anakinra or other biological agents.
• Previous combination DMARD therapy
• Receipt of any DMARD, other than MTX, within 28 days before screening.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Overall Contact: Trial Manager  clintrialparticipation@wyeth.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00706797

Study ID Number: 0881X1-4437

ClinicalTrials.gov Identifier: NCT00706797

Health Authority: France: Institutional Ethical Committee