Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00422227
First received: January 11, 2007
Last updated: July 28, 2010
Last verified: July 2010
Results First Received: March 31, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Etanercept , Methotrexate
Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

  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
Subjects were recruited in the Asia-Pacific Region from June 2007 to October 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening of subjects occurred up to 2 weeks before randomization followed by a treatment phase of 16 weeks and a 2-week safety follow up.

Reporting Groups
  Description
ETN/MTX Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
DMARD/MTX Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.

Participant Flow:   Overall Study
    ETN/MTX     DMARD/MTX  
STARTED     197     103  
COMPLETED     193     88  
NOT COMPLETED     4     15  
Adverse Event                 3                 8  
Lost to Follow-up                 1                 3  
Withdrawal by Subject                 0                 4  



  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
ETN/MTX Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
DMARD/MTX Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
Total Total of all reporting groups

Baseline Measures
    ETN/MTX     DMARD/MTX     Total  
Number of Participants  
[units: participants]
  197     103     300  
Age  
[units: years]
Mean ± Standard Deviation
  48.38  ± 11.98     48.52  ± 11.25     48.43  ± 11.72  
Gender  
[units: participants]
     
Female     180     91     271  
Male     17     12     29  



  Outcome Measures
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1.  Primary:   Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks   [ Time Frame: 16 weeks ]

2.  Secondary:   Percentage of Participants Achieving ACR 20, 50, and 70 Responses   [ Time Frame: Week 16 ]

3.  Secondary:   Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)   [ Time Frame: Week 16 ]
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Measure Type Secondary
Measure Title Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)
Measure Description Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).
Time Frame Week 16  
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.
The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.

Reporting Groups
  Description
ETN/MTX Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
DMARD/MTX Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.

Measured Values
    ETN/MTX     DMARD/MTX  
Number of Participants Analyzed  
[units: participants]
  197     103  
Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)  
[units: Percentage¬†of¬†Participants]
   
Low Disease (DAS28 <3.2)     39.09     18.45  
Remission (DAS28 <2.6)     15.74     7.77  


Statistical Analysis 1 for Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Low Disease (DAS28 <3.2)
[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:
  No text entered.

Statistical Analysis 2 for Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.069
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Remission (DAS28 <2.6)
[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:
  No text entered.



4.  Secondary:   Percent Change From Baseline in DAS28 at Week 16   [ Time Frame: Week 16 ]

5.  Secondary:   Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response   [ Time Frame: Week 16 ]

6.  Secondary:   Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2   [ Time Frame: Week 16 ]

7.  Secondary:   Percent Change From Baseline in Painful and Swollen Joint Counts   [ Time Frame: Week 2, 4, 8, 12, 16 ]

8.  Secondary:   Percent Change From Baseline in Physician And Subject Global Assessments   [ Time Frame: Week 2, 4, 8, 12, 16 ]

9.  Secondary:   Percent Change From Baseline in Duration (Minutes) of Morning Stiffness   [ Time Frame: Week 2, 4, 8, 12, 16 ]

10.  Secondary:   Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales   [ Time Frame: Week 2, 4, 8, 12, 16 ]


  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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