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


  Outcome Measures
  Show All 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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00422227     History of Changes
Other Study ID Numbers: 0881A1-408
Study First Received: January 11, 2007
Results First Received: March 31, 2010
Last Updated: July 28, 2010
Health Authority: Malaysia: Ministry of Health