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

Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept (ReSPONSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00992394
First received: October 8, 2009
Last updated: December 4, 2015
Last verified: December 2015
Results First Received: April 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psoriasis
Intervention: Drug: etanercept

  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
This multicenter open label, randomized study screened 209 participants in 44 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Psoriasis participants who had responded to initial treatment with ETN were enrolled in this study. Participants were randomized to 2 groups: Stop arm, stopped etanercept (ETN) treatment on study entry and could be retreated with ETN 50 mg once weekly. Maintenance arm, continued ETN treatment at 25 mg once weekly, but could increase dose to 50 mg.

Reporting Groups
  Description
Stop Arm Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
Maintenance Arm Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator

Participant Flow:   Overall Study
    Stop Arm     Maintenance Arm  
STARTED     88     86  
Safety Population     87     84  
mITT Population     86     84  
COMPLETED     64     72  
NOT COMPLETED     24     14  
Lack of Efficacy                 6                 3  
Adverse Event                 4                 5  
Withdrawal by Subject                 8                 2  
Physician Decision                 1                 0  
Protocol Violation                 2                 4  
Lost to Follow-up                 2                 0  
Other event                 1                 0  



  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.
A total of 174 subjects were randomized.Three subjects were randomized but did not take at least 1 dose of investigational product, and were therefore excluded from the safety population. One subject was excluded from the mITT population. The reason for exclusion was lack of at least one post-baseline PGA.

Reporting Groups
  Description
Stop Arm Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
Maintenance Arm Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
Total Total of all reporting groups

Baseline Measures
    Stop Arm     Maintenance Arm     Total  
Number of Participants  
[units: participants]
  87     84     171  
Age  
[units: Years]
Mean (Standard Deviation)
  50.39  (14.10)     47.71  (13.77)     49.08  (13.96)  
Gender  
[units: Participants]
     
Female     29     31     60  
Male     58     53     111  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52   [ Time Frame: Week 52 ]

2.  Secondary:   Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

4.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

5.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

6.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

7.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

8.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

9.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

10.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

11.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

12.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

13.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

14.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

15.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

16.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

17.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

18.  Secondary:   Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment   [ Time Frame: Baseline to Week 52 ]

19.  Secondary:   Physician Global Assessment (PGA) of Disease Activity at Week 52   [ Time Frame: Week 52 ]


  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
Enrollment in this study was slower than expected. Thus, recruitment was terminated early and only 58 percent of planned participants were randomized. As a result, no hypothesis testing was conducted and only descriptive statistics are reported.


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00992394     History of Changes
Other Study ID Numbers: 0881X1-4535
B1801021 ( Other Identifier: Alias Study Number )
2008-004439-39 ( EudraCT Number )
Study First Received: October 8, 2009
Results First Received: April 3, 2014
Last Updated: December 4, 2015
Health Authority: European Union: European Medicines Agency