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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Hong Kong, , Hong Kong
Contact
1-800-718-1021
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

NCT00422227
Pfizer
Completed
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

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Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Active Comparator: 1
    Etanercept + Methotrexate
    Intervention: Drug: Etanercept , Methotrexate
  • Active Comparator: 2
    DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
    Intervention: Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   India,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
 
 
NCT00422227
0881A1-408
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Hong Kong: [email protected]
Principal Investigator: Trial Manager For Taiwan: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
July 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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