Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis (REFINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01313221
First received: February 24, 2011
Last updated: February 19, 2016
Last verified: February 2016
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Biological: etanercept
Drug: Topical agents

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrollment :29 April 2011; last patient enrollment: 4 June 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 414 patients were screened,310 patients were enrolled and 287 randomized in this study; 144 in the etanercept monotherapy group (group A) and 143 in the etanercept plus an as-needed topical agent group (group B). 23 patients were not randomized because they did not complete the 12-week open-label treatment period before randomization.

Reporting Groups
  Description
Etanercept 50 mg BIW Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
Etanercept 50 mg QW + Topical Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Non-randomized Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.

Participant Flow:   Overall Study
    Etanercept 50 mg BIW   Etanercept 50 mg QW + Topical   Non-randomized
STARTED   144   143   23 
Randomized   144   143   0 
COMPLETED   132   135   0 
NOT COMPLETED   12   8   23 
Protocol Violation                0                1                1 
Non-compliance                3                0                2 
Withdrawal by Subject                2                3                5 
Requirement for alternative therapy                0                1                1 
Lost to Follow-up                6                3                1 
Other                1                0                0 
Adverse Event                0                0                7 
Disease progression                0                0                2 
Physician Decision                0                0                2 
Pregnancy                0                0                2 



  Baseline Characteristics
  Hide Baseline Characteristics

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 50 mg BIW Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
Etanercept 50 mg QW + Topical Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Non-randomized Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
Total Total of all reporting groups

Baseline Measures
   Etanercept 50 mg BIW   Etanercept 50 mg QW + Topical   Non-randomized   Total 
Overall Participants Analyzed 
[Units: Participants]
 144   143   23   310 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.7  (13.1)   46.3  (14.6)   36.6  (11.2)   45.3  (13.9) 
Gender 
[Units: Participants]
       
Female   46   49   14   109 
Male   98   94   9   201 
Race/Ethnicity, Customized 
[Units: Participants]
       
American Indian or Alaska Native   1   0   0   1 
Asian   14   5   0   19 
Mixed Race   1   0   0   1 
White   120   130   22   272 
Other   8   8   1   17 
Body Mass Index (BMI) 
[Units: Participants]
       
≤ 30   81   80   13   174 
> 30   63   63   10   136 
Prior anti-Tumor Necrosis Factor (TNF) Treatment [1] [2] [3] 
[Units: Participants]
       
Prior exposure   24   22   NA [2]   NA [3] 
Naive   116   120   NA [2]   NA [3] 
[1] Based on participants in the Efficacy Evaluable set, all randomized participants, who had taken at least 1 dose of study drug and had at least 1 postrandomization efficacy evaluation (140 and 142 particiapants in each randomized treatment group respectively).
[2] Not reported for non-randomized participants
[3] Total not calculated because data are not available (NA) in one or more arms.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24   [ Time Frame: Week 12 and Week 24 ]

2.  Secondary:   Percent Change in PASI From Week 12 to Weeks 16 and 20   [ Time Frame: Week 12, Week 16 and Week 20 ]

3.  Secondary:   Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24   [ Time Frame: Baseline and Weeks 12, 16, 20, and 24 ]

4.  Secondary:   Percentage of Participants With a PASI 50 Response   [ Time Frame: Baseline and Weeks 12, 16, 20 and 24 ]

5.  Secondary:   Percentage of Participants With a PASI 75 Response   [ Time Frame: Baseline and Weeks 12, 16, 20 and 24 ]

6.  Secondary:   Percentage of Participants With a PASI 90 Response   [ Time Frame: Baseline and Weeks 12, 16, 20 and 24 ]

7.  Secondary:   Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)   [ Time Frame: Weeks 12, 16, 20, and 24 ]

8.  Secondary:   Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24   [ Time Frame: Weeks 12, 16, 20, and 24 ]

9.  Secondary:   Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24   [ Time Frame: Baseline and Weeks 12, 16, 20, and 24 ]

10.  Secondary:   Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score   [ Time Frame: Week 12 and Week 24 ]

11.  Secondary:   Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score   [ Time Frame: Baseline and Week 12 and Week 24 ]

12.  Secondary:   Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24   [ Time Frame: Week 12 and Week 24 ]

13.  Secondary:   Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24   [ Time Frame: Baseline and Weeks 12 and 24 ]

14.  Secondary:   Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider   [ Time Frame: Baseline and 24 weeks ]

15.  Secondary:   Health Resource Utilization: Number of Participants With Home Healthcare Visits   [ Time Frame: Baseline and 24 weeks ]

16.  Secondary:   Health Resource Utilization: Number of Participants Requiring Paid Help With Chores   [ Time Frame: Baseline and 24 weeks ]

17.  Secondary:   Health Resource Utilization: Number of Participants Who Needed Friend or Family Care   [ Time Frame: Baseline and 24 weeks ]

18.  Secondary:   Health Resource Utilization: Out of Pocket Expenses   [ Time Frame: Baseline and 24 weeks ]

19.  Secondary:   Health Resource Utilization: Employment Status   [ Time Frame: Baseline and 24 weeks ]

20.  Secondary:   Health Resource Utilization: Productivity While Working   [ Time Frame: Baseline and 24 weeks ]

21.  Secondary:   Health Resource Utilization: Number of Participants With Missed Hours From Work   [ Time Frame: Baseline and 24 weeks ]

22.  Secondary:   Health Resource Utilization: Ability to Perform Daily Activities   [ Time Frame: Baseline and 24 weeks ]

23.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 32 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01313221     History of Changes
Other Study ID Numbers: 20090647
Study First Received: February 24, 2011
Results First Received: December 10, 2013
Last Updated: February 19, 2016
Health Authority: Canada: Health Canada