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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195494
First Posted: September 19, 2005
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
September 13, 2005
September 19, 2005
March 31, 2009
September 5, 2012
September 5, 2012
November 2004
March 2008   (Final data collection date for primary outcome measure)
  • The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. [ Time Frame: 12 months ]
    Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.
  • Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. [ Time Frame: 12 months ]
    The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.
  • To compare the effects of the combination of etanercept and methotrexate to
  • methotrexate alone on radiographic change and clinical disease activity in
  • subjects with active early rheumatoid arthritis over 12 months.
Complete list of historical versions of study NCT00195494 on ClinicalTrials.gov Archive Site
Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death [ Time Frame: 12 and 24 months ]
Safety report for entire trial where participants reported a serious adverse event that led to death.
  • Evaluate the safety of each treatment group over 24 months; compare the effects
  • of the combination of ETN and MTX to MTX alone on radiographic change and
  • clinical disease activity over 12 months and 24 months
Not Provided
Not Provided
 
Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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

  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
542
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00195494
0881A-101548
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2012

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