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Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00482170
First received: June 1, 2007
Last updated: March 1, 2012
Last verified: March 2012
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Device: Enbrel (etanercept)
Device: Etanercept

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Etanercept 50 mg Auto-injector Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
Etanercept 50 mg Prefilled Syringe Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.

Participant Flow:   Overall Study
    Etanercept 50 mg Auto-injector     Etanercept 50 mg Prefilled Syringe  
STARTED     207     214  
Treated     207     211  
COMPLETED     192     194  
NOT COMPLETED     15     20  
Adverse Event                 5                 14  
Withdrawal by Subject                 6                 1  
Protocol Violation                 2                 3  
Lost to Follow-up                 2                 0  
Unspecified reason                 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.
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Reporting Groups
  Description
Etanercept 50 mg Auto-injector Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
Etanercept 50 mg Prefilled Syringe Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Etanercept 50 mg Auto-injector     Etanercept 50 mg Prefilled Syringe     Total  
Number of Participants  
[units: participants]
  206     211     417  
Age [1]
[units: years]
Mean ± Standard Deviation
  46.1  ± 13.2     46.1  ± 13.4     46.1  ± 13.3  
Gender [2]
[units: participants]
     
Female     71     65     136  
Male     135     146     281  
[1] Out of a total of 421 participants, data for baseline measure (age) was available for 417 participants who were treated and had at least 1 efficacy evaluation.
[2] Out of a total of 421 participants, data for baseline measure (gender) was available for 417 participants who were treated and had at least 1 efficacy evaluation.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population   [ Time Frame: Week 12 ]

2.  Primary:   Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population   [ Time Frame: Week 12 ]

3.  Secondary:   Percentage of Participants Satisfied With Injection Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

4.  Secondary:   Influence of Age on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

5.  Secondary:   Influence of Gender on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

6.  Secondary:   Influence of Socio-educational Status on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

7.  Secondary:   Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

8.  Secondary:   Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

9.  Secondary:   Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

10.  Secondary:   Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

11.  Secondary:   Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

12.  Secondary:   Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

13.  Secondary:   Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

14.  Secondary:   Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

15.  Secondary:   Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

16.  Secondary:   Influence of Co-morbidities on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

17.  Secondary:   Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

18.  Secondary:   Influence of Prior Injection Experience on Participant Satisfaction With Injection Device   [ Time Frame: Week 12 ]

19.  Secondary:   Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

20.  Secondary:   Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

21.  Secondary:   Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

22.  Secondary:   Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete   [ Time Frame: Baseline, Week 4 and Week 12 ]

23.  Secondary:   Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting   [ Time Frame: Baseline, Week 4 and Week 12 ]

24.  Secondary:   Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting   [ Time Frame: Baseline, Week 4 and Week 12 ]

25.  Secondary:   Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)   [ Time Frame: Baseline, Week 4 and Week 12 ]

26.  Secondary:   Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity   [ Time Frame: Baseline, Week 4 and Week 12 ]

27.  Secondary:   Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity   [ Time Frame: Baseline, Week 4 and Week 12 ]

28.  Secondary:   Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling   [ Time Frame: Baseline, Week 4 and Week 12 ]

29.  Secondary:   Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections   [ Time Frame: Baseline, Week 4 and Week 12 ]

30.  Secondary:   Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time   [ Time Frame: Baseline, Week 4 and Week 12 ]

31.  Secondary:   Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

32.  Secondary:   Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process   [ Time Frame: Baseline, Week 4 and Week 12 ]

33.  Secondary:   Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection   [ Time Frame: Baseline, Week 4 and Week 12 ]

34.  Secondary:   Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections   [ Time Frame: Baseline, Week 4 and Week 12 ]

35.  Secondary:   Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin   [ Time Frame: Baseline, Week 4 and Week 12 ]

36.  Secondary:   Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

37.  Secondary:   Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection   [ Time Frame: Baseline, Week 4 and Week 12 ]

38.  Secondary:   Device Characteristics Based on Response to Question Concerning Look of Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

39.  Secondary:   Device Characteristics Based on Response to Question Concerning Feel of Device   [ Time Frame: Baseline, Week 4 and Week 12 ]

40.  Secondary:   Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks   [ Time Frame: Baseline, Week 4 and Week 12 ]

41.  Secondary:   Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection   [ Time Frame: Baseline, Week 4 and Week 12 ]

42.  Secondary:   Short Form State-Trait Anxiety Inventory (SF STAI) Global Score   [ Time Frame: Baseline, Week 4 and Week 12 ]

43.  Secondary:   Influence of Age on Participant Perception   [ Time Frame: Baseline ]

44.  Secondary:   Influence of Gender on Participant Perception   [ Time Frame: Baseline ]

45.  Secondary:   Influence of Socio-educational Status on Participant Perception   [ Time Frame: Baseline ]

46.  Secondary:   Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception   [ Time Frame: Baseline ]

47.  Secondary:   Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception   [ Time Frame: Baseline ]

48.  Secondary:   Influence of Prior Injection Experience on Participant Perception   [ Time Frame: Baseline ]

49.  Secondary:   Influence of Prior Self-injection Experience on Participant Perception   [ Time Frame: Baseline ]

50.  Secondary:   Influence of Duration of Psoriasis on Participant Perception   [ Time Frame: Baseline ]

51.  Secondary:   Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception   [ Time Frame: Baseline ]

52.  Secondary:   Influence of Psoriasis Area Severity Index (PASI) on Participant Perception   [ Time Frame: Baseline ]

53.  Secondary:   Influence of Participant's Assessment of General Health on Participant Perception   [ Time Frame: Baseline ]

54.  Secondary:   Influence of Participant's Global Assessment of Psoriasis on Participant Perception   [ Time Frame: Baseline ]

55.  Secondary:   Influence of Dermatology Life Quality Index (DLQI) on Participant Perception   [ Time Frame: Baseline ]

56.  Secondary:   Influence of Co-morbidities on Participant Perception   [ Time Frame: Baseline ]

57.  Secondary:   Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception   [ Time Frame: Baseline ]


  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
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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.


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: NCT00482170     History of Changes
Other Study ID Numbers: 0881A6-3326
Study First Received: June 1, 2007
Results First Received: March 1, 2012
Last Updated: March 1, 2012
Health Authority: European Union: European Medicines Agency