PsoriasisPhase 3NCT00482170
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
A Phase 3 study testing Enbrel (etanercept) and Etanercept in people with Psoriasis, run by Pfizer at 78 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Enbrel (etanercept) and Etanercept
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 78 sitesin 12 countries
- Study dates
- Sep 2007to Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
78 sites in 12 countries.
78 sites in 12 countries
Germany21 sites
Study site
Augsburg, 86179
Study site
Berlin, 10435
Study site
Berlin, 10827
Study site
Bonn, 53105
Study site
Cologne, 50931
Study site
Dresden, 01307
Study site
Dülmen, 48249
Study site
Erlangen, 91052
Study site
Freiburg im Breisgau, 79106
Study site
Göttingen, 37099
Study site
Greifswald, 17475
Study site
Hamburg, 20246
Study site
Lübeck, 23538
Study site
Mainz, 55101
Study site
Mannheim, 68135
Study site
München, 80802
Study site
Münster, 48149
Study site
Tübingen, 72076
Study site
Wiesbaden, 65199
Study site
Würzburg, 97070
Study site
Würzburg, D-97080
Italy11 sites
Study site
Bologna, 40128
Study site
Capranica, Viterbo, 01012
Study site
Como, 22100
Study site
Gallarate, Varese, 21013
Study site
Milan, 20122
Study site
Naples, 80131
Study site
Naples, 80132
Study site
Padova
Study site
Pisa, 56126
Study site
S. Giovanni Rotondo, Foggia, 71013
Study site
Terracina, Latina, ITALY 04019
France10 sites
Study site
Le Mans, Cedex, 72037
Study site
Limoges, 87042
Study site
Montpellier, 34000
Study site
Nancy, 54000
Study site
Nantes, 44093
Study site
Paris, 75010
Study site
Pessac, 33600
Study site
Pierre-Bénite, 69495
Study site
Reims, 51092
Study site
Toulouse, 31059
Belgium8 sites
Study site
Bruges, 08000
Study site
Brussels, 01070
Study site
Brussels, 01200
Study site
Edegem, B-2650
Study site
Ghent, 09000
Study site
Hasselt, 03500
Study site
Kapellen, 02950
Study site
Liège, B-4000
Spain6 sites
Study site
Córdoba, 14004
Study site
Elche, Alicante, 03203
Study site
Granada, 18012
Study site
Madrid, SPAIN 28046
Study site
Santander, Cantabria, 39008
Study site
Valencia, 46015
Finland4 sites
Study site
Helsinki, 00029 HUS
Study site
Helsinki, 00250
Study site
Joensuu, 802 10
Study site
Tampere, FIN-33521
Greece4 sites
Study site
Athens, 54644
Study site
Athens
Study site
Ioannina, 45332
Study site
Thessaloniki, 54644
Sweden4 sites
Study site
Danderyd, 182 88
Study site
Gothenburg, 41459
Study site
Linköping, SE-581 85
Study site
Malmö, SE-205 02
Denmark3 sites
Study site
Hellerup, 02900
Study site
Hørsholm, 02970
Study site
Roskilde, 04000
Netherlands3 sites
Study site
Breda, 4818 CK
Study site
Flushing, 4382 EE
Study site
Nijmegen, 06525
Norway3 sites
Study site
Bergen, 05021
Study site
Stavanger, 04068
Study site
Tromsø, N-9038
About this study
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.
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Enbrel (etanercept), Etanercept
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enbrel (etanercept)Device
Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
EtanerceptDevice
Arm 2 = Enbrel 50 mg Autoinjector twice weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm 1: Enbrel 50 mg Prefilled Syringe Receives: Device: Enbrel (etanercept) |
| 2 | Active comparator | Arm 2 Enbrel 50 mg Autoinjector Receives: Device: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
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.
Measured: Week 12
Secondary outcomes (55)
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.
Measured: Baseline, Week 4 and Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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)
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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'.
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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).
Measured: Baseline, Week 4 and Week 12
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.
Measured: Baseline, Week 4 and Week 12
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482170
- Sponsor's protocol ID
- 0881A6-3326
- Status last verified
- Mar 2012
- First submitted
- 1 Jun 2007
- Last updated
- 30 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00482170
- Acronym / sponsor ID
- 0881A6-3326
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Posted 30 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Enbrel (etanercept)Arm 1: Enbrel 50 mg Prefilled Syringe |
| 2 | Active comparator | Device: EtanerceptArm 2 Enbrel 50 mg Autoinjector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enbrel (etanercept)Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly | Device | 1 |
| EtanerceptArm 2 = Enbrel 50 mg Autoinjector twice weekly | Device | 2 |
Primary outcome
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
Time frame: Week 12
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
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.
55 secondary outcomes
Percentage of Participants Satisfied With Injection Device
Time frame: Baseline, Week 4 and Week 12
Influence of Age on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Gender on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Socio-educational Status on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Co-morbidities on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device
Time frame: Week 12
Influence of Prior Injection Experience on Participant Satisfaction With Injection Device
Time frame: Week 12
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
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
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
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
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
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Time frame: Baseline, Week 4 and Week 12
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
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
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
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Time frame: Baseline, Week 4 and Week 12
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Time frame: Baseline, Week 4 and Week 12
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
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
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Time frame: Baseline, Week 4 and Week 12
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Time frame: Baseline, Week 4 and Week 12
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Time frame: Baseline, Week 4 and Week 12
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
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Time frame: Baseline, Week 4 and Week 12
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
Device Characteristics Based on Response to Question Concerning Look of Device
Time frame: Baseline, Week 4 and Week 12
Device Characteristics Based on Response to Question Concerning Feel of Device
Time frame: Baseline, Week 4 and Week 12
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Time frame: Baseline, Week 4 and Week 12
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
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
Time frame: Baseline, Week 4 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
78 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enbrel (etanercept) and Etanercept in people with Psoriasis, run by Pfizer at 78 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in Germany, Italy, France, Belgium, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012; AzTrials last refreshed its copy on 27 Oct 2026.