Official Title: “A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis”

To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Etanercept, Methotrexate
  • Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2 Group 2b: Oral Methotrexate weekly for both Periods 1 and 2

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1a
  • Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
• Active Comparator: 1b
  • Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
• Active Comparator: 2a
  • Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
• Active Comparator: 2b
  • Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)

Primary Measures

• To compare the effects of the combination of etanercept and methotrexate to methotrexate alone on radiographic change
  • Time Frame: 12 months
    Safety Issue?: Yes
• To compare the effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity
  • Time Frame: 12 months
    Safety Issue?: Yes

Secondary Measures

• Evaluate the safety of each treatment group
  • Time Frame: 24 months
    Safety Issue?: Yes

Inclusion Criteria:

• Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
• Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion Criteria:

• Received any previous treatment with MTX
• Received any previous treatment with ETN or other tumour necrosis factor antagonist

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  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195494

Study ID Number: 0881A-101548

ClinicalTrials.gov Identifier: NCT00195494

Health Authority: European Union: European Medicines Agency