Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

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 in the Asia Pacific region.

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 than 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: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks
  • Time Frame: 16 weeks
    Safety Issue?: No

Secondary Measures

• Percentage of Participants Achieving ACR 20, 50, and 70 Responses
  • Time Frame: Week 16
    Safety Issue?: No
• Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)
  • Time Frame: Week 16
    Safety Issue?: No
• Percent Change From Baseline in DAS28 at Week 16
  • Time Frame: Week 16
    Safety Issue?: No
• Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response
  • Time Frame: Week 16
    Safety Issue?: No
• Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2
  • Time Frame: Week 16
    Safety Issue?: No
• Percent Change From Baseline in Painful and Swollen Joint Counts
  • Time Frame: Week 2, 4, 8, 12, 16
    Safety Issue?: No
• Percent Change From Baseline in Physician And Subject Global Assessments
  • Time Frame: Week 2, 4, 8, 12, 16
    Safety Issue?: No
• Percent Change From Baseline in Duration (Minutes) of Morning Stiffness
  • Time Frame: Week 2, 4, 8, 12, 16
    Safety Issue?: No
• Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales
  • Time Frame: Week 2, 4, 8, 12, 16
    Safety Issue?: No

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 Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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