AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Germany

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

Other trials in Italy

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

Other trials in France

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

Other trials in Belgium

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

Other trials in Spain

Finland4 sites
  • Study site

    Helsinki, 00029 HUS

  • Study site

    Helsinki, 00250

  • Study site

    Joensuu, 802 10

  • Study site

    Tampere, FIN-33521

Other trials in Finland

Greece4 sites
  • Study site

    Athens, 54644

  • Study site

    Athens

  • Study site

    Ioannina, 45332

  • Study site

    Thessaloniki, 54644

Other trials in Greece

Sweden4 sites
  • Study site

    Danderyd, 182 88

  • Study site

    Gothenburg, 41459

  • Study site

    Linköping, SE-581 85

  • Study site

    Malmö, SE-205 02

Other trials in Sweden

Denmark3 sites
  • Study site

    Hellerup, 02900

  • Study site

    Hørsholm, 02970

  • Study site

    Roskilde, 04000

Other trials in Denmark

Netherlands3 sites
  • Study site

    Breda, 4818 CK

  • Study site

    Flushing, 4382 EE

  • Study site

    Nijmegen, 06525

Other trials in Netherlands

Norway3 sites
  • Study site

    Bergen, 05021

  • Study site

    Stavanger, 04068

  • Study site

    Tromsø, N-9038

Other trials in Norway

Hungary1 site
  • Study site

    Szeged, 06720

Other trials in Hungary

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 groups in NCT00482170
Study groupRoleWhat they receive
1ExperimentalArm 1: Enbrel 50 mg Prefilled Syringe
Receives: Device: Enbrel (etanercept)
2Active comparatorArm 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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.

  1. First posted4 Jun 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionApr 2009
  4. Study completionSep 2009

Resources

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)
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

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.

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