Back to resultsCompare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Enbrel (etanercept)
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Arm 1: Enbrel 50 mg Prefilled Syringe
Arm 2 Enbrel 50 mg Autoinjector
Outcomes
Primary Outcome Measures
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00482170
Brief Title
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
421 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1: Enbrel 50 mg Prefilled Syringe
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2 Enbrel 50 mg Autoinjector
Intervention Type
Device
Intervention Name(s)
Enbrel (etanercept)
Intervention Description
Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
Intervention Type
Device
Intervention Name(s)
Etanercept
Intervention Description
Arm 2 = Enbrel 50 mg Autoinjector twice weekly
Primary Outcome Measure Information:
Title
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
Description
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.
Time Frame
Week 12
Title
Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Satisfied With Injection Device
Description
Participant satisfaction was assessed by asking the question "Are you satisfied with your injection device? and using a dichotomous response: Yes or No.
Time Frame
Baseline, Week 4 and Week 12
Title
Influence of Age on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Gender on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Socio-educational Status on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Co-morbidities on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Influence of Prior Injection Experience on Participant Satisfaction With Injection Device
Description
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.
Time Frame
Week 12
Title
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Description
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)
Time Frame
Baseline, Week 4 and Week 12
Title
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Description
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'.
Time Frame
Baseline, Week 4 and Week 12
Title
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Device Characteristics Based on Response to Question Concerning Look of Device
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Device Characteristics Based on Response to Question Concerning Feel of Device
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Description
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).
Time Frame
Baseline, Week 4 and Week 12
Title
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
Description
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.
Time Frame
Baseline, Week 4 and Week 12
Title
Influence of Age on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Gender on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Socio-educational Status on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Prior Injection Experience on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Prior Self-injection Experience on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Duration of Psoriasis on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Psoriasis Area Severity Index (PASI) on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Participant's Assessment of General Health on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Participant's Global Assessment of Psoriasis on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Dermatology Life Quality Index (DLQI) on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Co-morbidities on Participant Perception
Description
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.
Time Frame
Baseline
Title
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Brugge
ZIP/Postal Code
08000
Country
Belgium
City
Bruxelles
ZIP/Postal Code
01070
Country
Belgium
City
Bruxelles
ZIP/Postal Code
01200
Country
Belgium
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
City
Gent
ZIP/Postal Code
09000
Country
Belgium
City
Hasselt
ZIP/Postal Code
03500
Country
Belgium
City
Kapellen
ZIP/Postal Code
02950
Country
Belgium
City
Liège 1
ZIP/Postal Code
B-4000
Country
Belgium
City
Hellerup
ZIP/Postal Code
02900
Country
Denmark
City
Hørsholm
ZIP/Postal Code
02970
Country
Denmark
City
Roskilde
ZIP/Postal Code
04000
Country
Denmark
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
City
Joensuu
ZIP/Postal Code
802 10
Country
Finland
City
Tampere
ZIP/Postal Code
FIN-33521
Country
Finland
City
Le Mans
State/Province
Cedex
ZIP/Postal Code
72037
Country
France
City
Limoges
ZIP/Postal Code
87042
Country
France
City
Montpellier
ZIP/Postal Code
34000
Country
France
City
Nancy
ZIP/Postal Code
54000
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Pessac
ZIP/Postal Code
33600
Country
France
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
City
Berlin
ZIP/Postal Code
10435
Country
Germany
City
Berlin
ZIP/Postal Code
10827
Country
Germany
City
Bonn
ZIP/Postal Code
53105
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Duelmen
ZIP/Postal Code
48249
Country
Germany
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Goettingen
ZIP/Postal Code
37099
Country
Germany
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Koeln
ZIP/Postal Code
50931
Country
Germany
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
City
Mainz
ZIP/Postal Code
55101
Country
Germany
City
Mannheim
ZIP/Postal Code
68135
Country
Germany
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
City
Muenster
ZIP/Postal Code
48149
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
City
Athens
ZIP/Postal Code
54644
Country
Greece
City
Athens
Country
Greece
City
Ioannina
ZIP/Postal Code
45332
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54644
Country
Greece
City
Szeged
ZIP/Postal Code
06720
Country
Hungary
City
S. Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
City
Terracina
State/Province
Latina
ZIP/Postal Code
ITALY 04019
Country
Italy
City
Gallarate
State/Province
Varese
ZIP/Postal Code
21013
Country
Italy
City
Capranica
State/Province
Viterbo
ZIP/Postal Code
01012
Country
Italy
City
Bologna
ZIP/Postal Code
40128
Country
Italy
City
Como
ZIP/Postal Code
22100
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Napoli
ZIP/Postal Code
80132
Country
Italy
City
Padova
Country
Italy
City
Pisa
ZIP/Postal Code
56126
Country
Italy
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
06525
Country
Netherlands
City
Vlissingen
ZIP/Postal Code
4382 EE
Country
Netherlands
City
Bergen
ZIP/Postal Code
05021
Country
Norway
City
Stavanger
ZIP/Postal Code
04068
Country
Norway
City
Tromso
ZIP/Postal Code
N-9038
Country
Norway
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Granada
ZIP/Postal Code
18012
Country
Spain
City
Madrid
ZIP/Postal Code
SPAIN 28046
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Danderyd
ZIP/Postal Code
182 88
Country
Sweden
City
Göteborg
ZIP/Postal Code
41459
Country
Sweden
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
We'll reach out to this number within 24 hrs