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
  Purpose

Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.


Condition Intervention Phase
Psoriasis
Device: Enbrel (etanercept)
Device: Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.

  • Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.


Secondary Outcome Measures:
  • Percentage of Participants Satisfied With Injection Device [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was assessed by asking the question "Are you satisfied with your injection device? and using a dichotomous response: Yes or No.

  • Influence of Age on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years.

  • Influence of Gender on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.

  • Influence of Socio-educational Status on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.

  • Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D.

  • Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5.

  • Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.

  • Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years.

  • Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4.

  • Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9.

  • Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84.

  • Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88.

  • Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18.

  • Influence of Co-morbidities on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.

  • Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.

  • Influence of Prior Injection Experience on Participant Satisfaction With Injection Device [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.

  • 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 ] [ Designated as safety issue: No ]
    Ease of use of injection device was assessed by participant's response to question, "How easy was it to perform an injection with this device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).

  • 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 ] [ Designated as safety issue: No ]
    Ease of use of injection device was assessed by participant's response to question, "How easy was it to use the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).

  • 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 ] [ Designated as safety issue: No ]
    Ease of use of injection device was assessed by participant's response to question, "How easy was it to dispose of the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).

  • 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 ] [ Designated as safety issue: No ]
    Ease of use of injection device was assessed by participant's response to question, "How easy is it to know when the injection is completed?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).

  • 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 ] [ Designated as safety issue: No ]
    Ease of use of injection device was assessed by participant's response to question, "How easy is it to hold the device whilst injecting?" scored on a 5-point Likert scale (0= very easy to 4= very difficult)

  • Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Ease of use of injection device was assessed by participant's response to question, "Did you feel any hand discomfort whilst using the device?" scored on a 5-point Likert scale (0= none to 4= extreme).

  • 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 ] [ Designated as safety issue: No ]
    Ease of Use of Injection Device was assessed by participant's response to question, "How long does it take to perform the injection, including any preparation and disposal?" where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'.

  • 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 ] [ Designated as safety issue: No ]
    Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • 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 ] [ Designated as safety issue: No ]
    Convenience of injection device was assessed by participant's response to question, "Do you think injecting etanercept will interfere with your usual daily activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Confidence in injection device was assessed by participant's response to question, "How confident are you in your management of your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • 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 ] [ Designated as safety issue: No ]
    Confidence in injection device was assessed by participant's response to question, "How confident are you that you inject the right amount of medicine every time?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • 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 ] [ Designated as safety issue: No ]
    Confidence in injection device was assessed by participant's response to question, "How confident are you that you can inject yourself properly with the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Confidence in injection device was assessed by participant's response to question, "Are you confident that you have good control over the injection process?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Confidence in injection device was assessed by participant's response to question, "How confident are you that you injected yourself successfully?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Fear of Device was assessed by participant's response to question, "How nervous do you feel about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • 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 ] [ Designated as safety issue: No ]
    Fear of Device was assessed by participant's response to question, "How nervous do you feel about inserting the needle into your skin?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Fear of Device was assessed by participant's response to question, "Do you dislike injecting yourself with this device?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • 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 ] [ Designated as safety issue: No ]
    Fear of Device was assessed by participant's response to question, "Are you emotionally distressed or anxious about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Device Characteristics Based on Response to Question Concerning Look of Device [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Device characteristics were assessed by participant's response to question, "How much do you like the look of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Device Characteristics Based on Response to Question Concerning Feel of Device [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Device characteristics were assessed by participant's response to question, "How much do you like the feel of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Device characteristics were assessed by participant's response to question, "How much does the device look like something you would feel comfortable to use?" scored on a 5-point Likert scale (0= not at all to 4= very much).

  • 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 ] [ Designated as safety issue: No ]
    Side effects related to administration were assessed by participant's response to question, "Do you experience pain during or immediately after the injection?" scored on a 5-point Likert scale (0= none to 4= severe).

  • Short Form State-Trait Anxiety Inventory (SF STAI) Global Score [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.

  • Influence of Age on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.

  • Influence of Gender on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.

  • Influence of Socio-educational Status on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.

  • Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.

  • Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.

  • Influence of Prior Injection Experience on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.

  • Influence of Prior Self-injection Experience on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.

  • Influence of Duration of Psoriasis on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.

  • Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.

  • Influence of Psoriasis Area Severity Index (PASI) on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.

  • Influence of Participant's Assessment of General Health on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants.

  • Influence of Participant's Global Assessment of Psoriasis on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants.

  • Influence of Dermatology Life Quality Index (DLQI) on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.

  • Influence of Co-morbidities on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.

  • Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.


Enrollment: 421
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1: Enbrel 50 mg Prefilled Syringe
Device: Enbrel (etanercept)
Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
Active Comparator: 2
Arm 2 Enbrel 50 mg Autoinjector
Device: Etanercept
Arm 2 = Enbrel 50 mg Autoinjector twice weekly

Detailed Description:

For the measures of patient's satisfaction with and perceptions of, their device, standard Likert scales are used. This allows the magnitude of individual's perceptions and satisfaction to be measured on a multipoint scale anchored at each end. In addition, the study will describe patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, injection site pain, injection anxiety, injection confidence) will be captured using a questionnaire. The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, demographics, social and educational status psychological status, willingness to self-manage, injection experience) and Psoriasis characteristics (e.g. disease severity, disease duration, co morbidities, prior treatment, quality of life). The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
  • Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
  • Aged 18 years or more
  • Willing and able to self-inject etanercept.
  • Able to store test drug at 2-8oC.
  • Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.
  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.

Exclusion Criteria:

  • Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept.
  • Sepsis or risk of sepsis.
  • Current or recent infections, including chronic or localized.
  • Latex sensitivity.
  • Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482170

  Show 78 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014