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Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00936065
First received: July 7, 2009
Last updated: March 12, 2012
Last verified: March 2012
Results First Received: March 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Moderate to Severe Psoriasis
Interventions: Drug: Etanercept
Drug: Etanercept + Acitretin
Drug: Acitretin

  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
No text entered.

Reporting Groups
  Description
Etanercept Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin Acitretin 10 mg subcutaneous injection BID for 24 weeks

Participant Flow:   Overall Study
    Etanercept     Etanercept and Acitretin     Acitretin  
STARTED     21     20     19  
Received Treatment     21     20     18  
Study Assessments Performed     21     19     18  
COMPLETED     17     16     12  
NOT COMPLETED     4     4     7  
Adverse Event                 1                 0                 1  
Lack of Efficacy                 1                 0                 1  
Lost to Follow-up                 1                 0                 0  
Protocol Violation                 1                 2                 1  
Withdrawal by Subject                 0                 2                 4  



  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 Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept and Acitretin Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin Acitretin 10 mg subcutaneous injection BID for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Etanercept     Etanercept and Acitretin     Acitretin     Total  
Number of Participants  
[units: participants]
  21     19     18     58  
Age  
[units: years]
Mean ± Standard Deviation
  38.57  ± 9.53     35.5  ± 8.75     42.39  ± 11.95     38.78  ± 10.31  
Gender  
[units: participants]
       
Female     5     2     3     10  
Male     16     17     15     48  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score   [ Time Frame: Weeks 2, 4, 8, 12, 18, and 24 ]

3.  Secondary:   Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

4.  Secondary:   Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

5.  Secondary:   Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

6.  Secondary:   Time to Achieve a PASI 50 Score   [ Time Frame: Baseline up to Week 24 ]

7.  Secondary:   Time to Achieve a PASI 75 Score   [ Time Frame: Baseline up to Week 24 ]

8.  Secondary:   Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild   [ Time Frame: Baseline up to Week 24 ]

9.  Secondary:   Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear   [ Time Frame: Baseline up to Week 24 ]

10.  Secondary:   Change From Baseline in the PGA of Psoriasis   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18, and 24 ]

11.  Secondary:   Change From Baseline in the PASI Score   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

12.  Secondary:   Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

13.  Secondary:   Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

14.  Secondary:   Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24 ]

15.  Secondary:   Change From Baseline in SGA of Itching at Each Visit   [ Time Frame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24 ]

16.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

17.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

18.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

19.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

20.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

21.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

22.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

23.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

24.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

25.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

26.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

27.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

28.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

29.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

30.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

31.  Secondary:   Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

32.  Secondary:   Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]

33.  Secondary:   Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24   [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24 ]


  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
One of the protocol-defined endpoints was change from baseline in the participant's assessment of general health, however data was collected and analyzed for change from baseline in the participant's assessment of joint pain.


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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00936065     History of Changes
Other Study ID Numbers: 0881A6-4625, B1801065
Study First Received: July 7, 2009
Results First Received: March 12, 2012
Last Updated: March 12, 2012
Health Authority: Korea: Food and Drug Administration