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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00422227 |
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Date of registration:
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11/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
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Scientific title:
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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 |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00422227 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Hong Kong
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India
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Korea, Republic of
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Malaysia
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Philippines
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Singapore
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Taiwan
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Thailand
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Hong Kong: medinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Taiwan: medinfo@wyeth.com |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Etanercept , Methotrexate
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Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Percent Change From Baseline in Painful and Swollen Joint Counts
[Time Frame: Week 2, 4, 8, 12, 16]
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Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response
[Time Frame: Week 16]
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Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)
[Time Frame: Week 16]
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Percent Change From Baseline in DAS28 at Week 16
[Time Frame: Week 16]
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Percent Change From Baseline in Physician And Subject Global Assessments
[Time Frame: Week 2, 4, 8, 12, 16]
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Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales
[Time Frame: Week 2, 4, 8, 12, 16]
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Percentage of Participants With DAS28 Improvement of =0.6 and =1.2
[Time Frame: Week 16]
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Percentage of Participants Achieving ACR 20, 50, and 70 Responses
[Time Frame: Week 16]
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Percent Change From Baseline in Duration (Minutes) of Morning Stiffness
[Time Frame: Week 2, 4, 8, 12, 16]
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Secondary ID(s)
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0881A1-408
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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