Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

NCT00565409

Last updated date
Study Location
Pfizer Investigational Site
Campsie, New South Wales, 2194, Australia
Contact
1-800-718-1021

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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 rheumatoid arthritis.

- Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.

- Active rheumatoid arthritis at the time of screening.

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


- Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF)
inhibitors, or other biologic agents.


- Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other
than MTX within 28 days before baseline.


- Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at
baseline.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Official Title  ICMJE A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
Brief Summary To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: Etanercept
    Subcutaneous (SC), 50 mg, once weekly for 88 weeks
    Other Name: Enbrel
  • Drug: Methotrexate

    Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

    If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

  • Drug: Etanercept
    Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
  • Drug: Placebo
    Subcutaneous (SC), once weekly from week 36 to week 88.
Study Arms  ICMJE
  • Active Comparator: 1
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Active Comparator: 2
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Placebo Comparator: 3
    Interventions:
    • Drug: Placebo
    • Drug: Methotrexate
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: February 7, 2012)
834
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2007)
900
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis.
  • Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
  • Active rheumatoid arthritis at the time of screening.

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
  • Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
  • Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
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 Australia,   Austria,   Belgium,   Chile,   Colombia,   Czech Republic,   Former Serbia and Montenegro,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
Removed Location Countries Brazil,   Korea, Democratic People's Republic of,   Serbia
 
Administrative Information
NCT Number  ICMJE NCT00565409
Other Study ID Numbers  ICMJE 0881A1-4423
B1801003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2015

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