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Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00706797
First received: June 25, 2008
Last updated: June 16, 2011
Last verified: June 2011
History of Changes
Results First Received: December 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: etanercept (EnbrelTM)
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
141 participants were randomized, 1 participant performed all the planned visits, and 140 participants were discontinued before completion of the study; 115 participants prematurely withdrew due to discontinuation of the study by the sponsor.

Reporting Groups
  Description
Usual Care Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
ETN + MTX Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).

Participant Flow:   Overall Study
    Usual Care     ETN + MTX  
STARTED     70     71  
Safety Population     63 [1]   71  
COMPLETED     1     0  
NOT COMPLETED     69     71  
Lack of Efficacy                 3                 0  
Adverse Event                 0                 3  
Withdrawal by Subject                 8                 1  
Death                 1                 0  
Discontinuation of study by sponsor                 52                 63  
Protocol Violation                 3                 2  
Lost to Follow-up                 1                 2  
Unspecified                 1                 0  
[1] Safety population=all randomly assigned subjects who had at least 1 dose of study treatment.



  Baseline Characteristics
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Reporting Groups
  Description
Usual Care Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
ETN + MTX Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
Total Total of all reporting groups

Baseline Measures
    Usual Care     ETN + MTX     Total  
Number of Participants  
[units: participants]
 		  63     71     134  
Age  
[units: years]
Mean ± Standard Deviation 		  57.3  ± 12.1     53.8  ± 13.1     55.5  ± 12.7  
Gender  
[units: participants]
 		     
Female     50     56     106  
Male     13     15     28  



  Outcome Measures
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1.  Primary:   Change From Baseline in Modified Total Sharp Score (TSS) at Week 52   [ Time Frame: Baseline, Week 52 ]
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2.  Secondary:   Change From Baseline in Erosions at Week 52   [ Time Frame: Baseline, Week 52 ]
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3.  Secondary:   Change From Baseline in Joint Space Narrowing at Week 52   [ Time Frame: Baseline, Week 52 ]
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4.  Secondary:   Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52   [ Time Frame: Baseline, Week 52, Last observation carried forward (LOCF) ]
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5.  Secondary:   Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)   [ Time Frame: Baseline, Week 12, Week 24, and Week 52 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Achieving Remission (DAS28 <2.60)   [ Time Frame: Week 12, Week 24, and Week 52 ]
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7.  Secondary:   Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)   [ Time Frame: Week 12, Week 24, and Week 52 ]
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8.  Secondary:   Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response   [ Time Frame: Week 12, Week 24, and Week 52 ]
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9.  Secondary:   Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria   [ Time Frame: Week 12, Week 24, Week 52 ]
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10.  Secondary:   Percentage of Participants With American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Week 12, Week 24, Week 52 ]
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11.  Secondary:   Percentage of Participants With American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Week 12, Week 24, Week 52 ]
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12.  Secondary:   Percentage of Participants With American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Week 12, Week 24, Week 52 ]
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13.  Secondary:   Percentage of Participants With American College of Rheumatology 90% (ACR90) Response   [ Time Frame: Week 12, Week 24, Week 52 ]
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14.  Secondary:   Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period   [ Time Frame: Week 4, Week 12, Week 24, Week 40, Week 52 ]
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15.  Secondary:   Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)   [ Time Frame: Week 12, Week 52 ]
  Hide Outcome Measure 15

Measure Type Secondary
Measure Title Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)
Measure Description Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.
Time Frame Week 12, Week 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; efficacy data not analyzed due to early termination of the study.

Reporting Groups
  Description
Usual Care Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
ETN + MTX Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).

Measured Values
    Usual Care     ETN + MTX  
Number of Participants Analyzed  
[units: participants]
 		  0     0  
Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)  
[units: percentage of participants]
 		       

No statistical analysis provided for Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)



16.  Secondary:   Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)   [ Time Frame: Week 4, Week 12, Week 24, Week 40, Week 52 ]
  Show Outcome Measure 16

17.  Secondary:   Health Related Quality of Life: EuroQol-5D Health Index   [ Time Frame: Baseline, Week 12, Week 24, and Week 52 ]
  Show Outcome Measure 17

18.  Secondary:   Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)   [ Time Frame: Baseline, Week 12, Week 24, and Week 52 ]
  Show Outcome Measure 18


  Serious Adverse Events
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  Other Adverse Events
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  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
Following early termination of the study, only disposition of randomized participants, description of demographic data on safety population, and safety analyses were performed.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


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

Publications automatically indexed to this study:


Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00706797     History of Changes
Other Study ID Numbers: 0881X1-4437
Study First Received: June 25, 2008
Results First Received: December 22, 2010
Last Updated: June 16, 2011
Health Authority: Australia: National Health and Medical Research Council