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

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NCT00422227

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Study Location
Hong Kong, , , Hong Kong
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Etanercept + Methotrexate
    Intervention: Drug: Etanercept , Methotrexate
  • Active Comparator: 2
    DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
    Intervention: Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2007)		300
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   India,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00422227
Other Study ID Numbers  ICMJE 0881A1-408
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Hong Kong: [email protected]
Principal Investigator:Trial ManagerFor Taiwan: [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP