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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195494
First received: September 13, 2005
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: March 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Etanercept
Drug: Methotrexate
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Year 1 M+Placebo

Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Year 1 E+M

Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Total Total of all reporting groups

Baseline Measures
    Year 1 M+Placebo     Year 1 E+M     Total  
Number of Participants  
[units: participants]
  268     274     542  
Age [1]
[units: years]
Median ( Full Range )
  51.50  
  ( 20.00 to 84.00 )  
  52.50  
  ( 18.00 to 82.00 )  
  52.00  
  ( 18.00 to 84.00 )  
Gender [2]
[units: Year¬†1¬†participants]
     
Female     194     204     398  
Male     74     70     144  
[1] Year 1 Overall Number of Baseline Participants is 542
[2] Year 1 participants collected from Arms M and E+M equal the stated overall participant population of 542. 411 of those participants were then entered into Year 2 Arms E+M/E+M, M/M+E, E+M/E, M/M. This measure provides the gender population for Year 1 only in order to accurately reflect the overall baseline population of 542.



  Outcome Measures
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1.  Primary:   The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.   [ Time Frame: 12 months ]

2.  Primary:   Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.   [ Time Frame: 12 months ]

3.  Secondary:   Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death   [ Time Frame: 12 and 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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