Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

NCT00195494

Last updated date
Study Location
Denver, Colorado, 80230, United States
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 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis

- Has RA greater than or equal to 3 months and less than or equal to 2 years

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


- Received any previous treatment with MTX


- Received any previous treatment with ETN or other tumour necrosis factor antagonist

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
Official Title  ICMJE A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
Brief Summary To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Etanercept

    Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2

    Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2

    Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2

  • Drug: Methotrexate

    Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2

    Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2

    Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2

    Group 2b: Oral Methotrexate weekly for both Periods 1 and 2

  • Drug: Placebo

    Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2

    Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2

Study Arms  ICMJE
  • Active Comparator: 1a
    Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Active Comparator: 1b
    Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
    • Drug: Placebo
  • Active Comparator: 2a
    Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
    • Drug: Placebo
  • Active Comparator: 2b
    Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)
    Intervention: 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: August 1, 2012)
542
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
540
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
  • Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion Criteria:

  • Received any previous treatment with MTX
  • Received any previous treatment with ETN or other tumour necrosis factor antagonist
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195494
Other Study ID Numbers  ICMJE 0881A-101548
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2012

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