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Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00445770
First received: March 8, 2007
Last updated: August 10, 2011
Last verified: August 2011
Results First Received: July 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Etanercept
Drug: Methotrexate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Methotrexate Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
Etanercept 10 mg Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
Etanercept 25 mg Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks

Participant Flow:   Overall Study
    Methotrexate     Etanercept 10 mg     Etanercept 25 mg  
STARTED     176     192     182  
COMPLETED     123     157     151  
NOT COMPLETED     53     35     31  
Adverse Event                 9                 15                 19  
Lack of Efficacy                 38                 13                 6  
Lost to Follow-up                 0                 2                 0  
Not specified                 6                 5                 6  



  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.
No text entered.

Reporting Groups
  Description
Methotrexate Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
Etanercept 10 mg Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
Etanercept 25 mg Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
Total Total of all reporting groups

Baseline Measures
    Methotrexate     Etanercept 10 mg     Etanercept 25 mg     Total  
Number of Participants  
[units: participants]
  176     192     182     550  
Age  
[units: years]
Mean ± Standard Deviation
  50.40  ± 11.91     51.46  ± 12.21     51.81  ± 11.07     51.24  ± 11.74  
Gender  
[units: participants]
       
Female     140     154     145     439  
Male     36     38     37     111  
modified Total Sharp Score (mTSS) [1]
[units: scores on a scale]
Mean ± Standard Deviation
  43.01  ± 46.78     45.17  ± 38.75     41.98  ± 41.51     43.42  ± 42.28  
Erosion Score [2]
[units: scores on a scale]
Mean ± Standard Deviation
  25.09  ± 26.30     26.66  ± 22.1     25.23  ± 23.88     25.69  ± 24.05  
Joint Space Narrowing (JSN) Score [3]
[units: scores on a scale]
Mean ± Standard Deviation
  17.92  ± 21.93     18.50  ± 19.14     16.75  ± 19.11     17.73  ± 20.03  
[1] mTSS=sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). Total mTSS scores possible ranged from 0 (normal) to 448 (worst possible total score).
[2] Joint erosion score: erosion severity in 44 joints (16 per hand and 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, total erosion score possible ranged from 0 (no erosion) to 280 (worst possible total score).
[3] JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Total JSN scores possible ranged from 0 (no/normal JSN) to 168 (worst possible total score).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52   [ Time Frame: Week 52 ]

2.  Secondary:   Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Change From Baseline in Erosion Score at Weeks 24 and 52   [ Time Frame: Baseline, Week 24, and Week 52 ]

4.  Secondary:   Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52   [ Time Frame: Baseline, Week 24, and Week 52 ]

5.  Secondary:   Percentage of Participants With no Progression of Joint Destruction at Week 52   [ Time Frame: Baseline and Week 52 ]

6.  Secondary:   Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

7.  Secondary:   Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

8.  Secondary:   Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

9.  Secondary:   Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

10.  Secondary:   Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

11.  Secondary:   Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

12.  Secondary:   Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

13.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

14.  Secondary:   Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

15.  Secondary:   Percentage of Participants With an ACR50 Response   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

16.  Secondary:   Percentage of Participants With an ACR70 Response   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

17.  Secondary:   Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

18.  Secondary:   Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

19.  Secondary:   Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

20.  Secondary:   Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52   [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]
  Hide Outcome Measure 20

Measure Type Secondary
Measure Title Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Measure Description ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52  
Safety Issue No  

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.
mITT; LOCF

Reporting Groups
  Description
Methotrexate Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
Etanercept 10 mg Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
Etanercept 25 mg Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks

Measured Values
    Methotrexate     Etanercept 10 mg     Etanercept 25 mg  
Number of Participants Analyzed  
[units: participants]
  176     192     182  
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52  
[units: mm/hr]
Mean ± Standard Deviation
     
Baseline     42.55  ± 28.24     42.00  ± 29.44     43.66  ± 27.64  
Change at Week 2     -1.86  ± 10.65     -13.67  ± 13.07     -16.91  ± 15.01  
Change at Week 4     -2.92  ± 11.78     -13.26  ± 14.94     -16.62  ± 16.03  
Change at Week 8     -5.50  ± 16.89     -13.99  ± 17.39     -18.01  ± 17.83  
Change at Week 12     -8.89  ± 17.38     -15.18  ± 17.63     -18.98  ± 19.04  
Change at Week 16     -8.56  ± 18.73     -15.45  ± 18.54     -19.78  ± 20.32  
Change at Week 20     -10.56  ± 20.45     -15.68  ± 19.15     -19.40  ± 20.18  
Change at Week 24     -9.88  ± 20.15     -16.52  ± 20.09     -20.01  ± 20.86  
Change at Week 32     -9.92  ± 20.51     -16.06  ± 21.14     -20.16  ± 21.54  
Change at Week 40     -9.33  ± 20.50     -15.93  ± 21.47     -18.28  ± 21.81  
Change at Week 48     -10.70  ± 20.93     -15.61  ± 23.07     -19.25  ± 21.77  
Change at Week 52     -10.22  ± 21.69     -14.79  ± 23.06     -18.85  ± 21.67  


Statistical Analysis 1 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 2
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior Methotrexate use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 2
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0274
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 2
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.

Statistical Analysis 4 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 4
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 5 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 4
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 6 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0344
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 4
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 7 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 8
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 8 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 8
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 9 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0293
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 8
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 10 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 12
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 11 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 12
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 12 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0452
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 12
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 13 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 16
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 14 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 16
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 15 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0313
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 16
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 16 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 20
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 17 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] 0.0019
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 20
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 18 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0781
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 20
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 19 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 24
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 20 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 24
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 21 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.1279
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 24
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 22 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 32
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 23 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] 0.0004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 32
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 24 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0807
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 32
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 25 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 40
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 26 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] 0.0002
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 40
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 27 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.4180
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 40
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 28 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 29 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] 0.0061
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 30 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.1615
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 31 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 32 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Methotrexate vs. Etanercept 10 mg
Method [2] ANCOVA
P Value [3] 0.0130
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 33 for Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Groups [1] Etanercept 10 mg vs. Etanercept 25 mg
Method [2] ANCOVA
P Value [3] 0.0948
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Week 52
[2] Other relevant method information, such as adjustments or degrees of freedom:
  p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



21.  Other Pre-specified:   Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses   [ Time Frame: Weeks 12, 24, 52 ]


  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
Total Sharp Score and modified total Sharp Score were used interchangeably in the protocol and meant the same thing. In the statistical analysis plan and study results, mTSS was used consistently.


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