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

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. Identifier: NCT00422227
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : August 30, 2010
Last Update Posted : August 30, 2010
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Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Etanercept , Methotrexate
Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

  Participant Flow

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
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
STARTED   197   103 
COMPLETED   193   88 
Adverse Event                3                8 
Lost to Follow-up                1                3 
Withdrawal by Subject                0                4 

  Baseline Characteristics

  Outcome Measures

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 ]

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

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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  More Information