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The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01001208
First received: October 15, 2009
Last updated: July 10, 2013
Last verified: July 2013
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Methotrexate
Drug: Etanercept
Drug: Placebo

  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
Participants were enrolled from 09 November 2009 through 25 June 2010

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
Etanercept + Methotrexate Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Etanercept + Placebo Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.

Participant Flow:   Overall Study
    Etanercept + Methotrexate   Etanercept + Placebo
STARTED   239   239 
COMPLETED   211   206 
NOT COMPLETED   28   33 
Adverse Event                10                5 
Lost to Follow-up                5                9 
Physician Decision                1                0 
Withdrawal by Subject                4                5 
Ineligibility Determined                4                2 
Noncompliance                4                7 
Disease Progression                0                3 
Other                0                2 



  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
Etanercept + Methotrexate Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Etanercept + Placebo Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Total Total of all reporting groups

Baseline Measures
   Etanercept + Methotrexate   Etanercept + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 239   239   478 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.99  (13.06)   45.23  (12.79)   44.11  (12.96) 
Gender 
[Units: Participants]
     
Female   86   72   158 
Male   153   167   320 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   10   9   19 
Native Hawaiian or Other Pacific Islander   2   1   3 
Black or African American   4   10   14 
White   179   177   356 
Hispanic or Latino   42   39   81 
Japanese   0   0   0 
Other   1   3   4 
Aborigine   0   0   0 
Psoriasis Area and Severity Index (PASI) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.24  (8.15)   18.34  (6.62)   18.29  (7.42) 
[1] Psoriasis Area and Severity Index (PASI) Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by physicians using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Percent of Body Surface Area (BSA) Involved in Psoriasis 
[Units: Percentage of BSA]
Mean (Standard Deviation)
 24.43  (15.94)   24.23  (13.64)   24.33  (14.82) 
Body Mass Index Group 
[Units: Participants]
     
<=35 kg/m^2   172   173   345 
>35 kg/m^2   67   66   133 
Prior Anti-tumor Necrosis Factor (TNF) Exposure 
[Units: Participants]
     
Yes   42   48   90 
No   197   191   388 


  Outcome Measures
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1.  Primary:   PASI 75 Response at Week 24   [ Time Frame: Baseline and 24 Weeks ]

2.  Secondary:   PASI 50 Response at Week 24   [ Time Frame: Baseline and 24 Weeks ]

3.  Secondary:   Static Physician Global Assessment (sPGA) Response at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   PASI 50 Response at Week 12   [ Time Frame: Baseline and 12 Weeks ]

5.  Secondary:   PASI 75 Response at Week 12   [ Time Frame: Baseline and 12 Weeks ]

6.  Secondary:   Static Physician Global Assessment (sPGA) Response at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   PASI 90 Response at Week 12   [ Time Frame: Baseline and 12 Weeks ]

8.  Secondary:   PASI 90 Response at Week 24   [ Time Frame: Baseline and 24 Weeks ]

9.  Secondary:   Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12   [ Time Frame: Baseline and 12 Weeks ]

10.  Secondary:   Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24   [ Time Frame: Baseline and 24 Weeks ]


  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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436



Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01001208     History of Changes
Other Study ID Numbers: 20070559
Study First Received: October 15, 2009
Results First Received: December 21, 2011
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Western Institutional Review Board
Canada: Health Canada