Official Title: “A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis”

The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: Etanercept , Methotrexate
  • Etanercept: 25 mg twice weekly over 16 weeks, SC Methotrexate: > 7.5 mg/week and no more than 25 mg/week, PO
• Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
  • Methotrexate: at least 7.5 mg/wk and not more thans 25 mg/wk.;PO Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day Leflunomide: Initialy, loading dose 100 mg daily for 3 days. Maintainance : 20 mg daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Etanercept + Methotrexate
• Active Comparator: 2
  • DMARD therapy Methotrexate + Sulfasalazine/Hydroxycloroquine/Leflunomide

Primary Measures

• American College of Rheumatology (ACR) response
  • Time Frame: 16 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Diagnosis of RA
• Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
• Active RA at time of screening and baseline

Exclusion Criteria:

• Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
• Concurrent treatment with a DMARD, other than MTX, at screening
• Receipt of any DMARD, other than MTX, within 3 months before screening

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

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/NCT00422227

Study ID Number: 0881A1-408

ClinicalTrials.gov Identifier: NCT00422227

Health Authority: Malaysia: Ministry of Health