Clinical trial NCT00482170: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
timeFrame: Week 12
measure: Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Satisfied With Injection Device
timeFrame: Baseline, Week 4 and Week 12
measure: Influence of Age on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Gender on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Socio-educational Status on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Co-morbidities on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Influence of Prior Injection Experience on Participant Satisfaction With Injection Device
timeFrame: Week 12
measure: Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
timeFrame: Baseline, Week 4 and Week 12
measure: Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
timeFrame: Baseline, Week 4 and Week 12
measure: Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
timeFrame: Baseline, Week 4 and Week 12
measure: Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
timeFrame: Baseline, Week 4 and Week 12
measure: Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
timeFrame: Baseline, Week 4 and Week 12
measure: Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
timeFrame: Baseline, Week 4 and Week 12
measure: Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
timeFrame: Baseline, Week 4 and Week 12
measure: Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
timeFrame: Baseline, Week 4 and Week 12
measure: Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
timeFrame: Baseline, Week 4 and Week 12
measure: Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
timeFrame: Baseline, Week 4 and Week 12
measure: Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
timeFrame: Baseline, Week 4 and Week 12
measure: Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
timeFrame: Baseline, Week 4 and Week 12
measure: Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
timeFrame: Baseline, Week 4 and Week 12
measure: Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
timeFrame: Baseline, Week 4 and Week 12
measure: Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
timeFrame: Baseline, Week 4 and Week 12
measure: Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
timeFrame: Baseline, Week 4 and Week 12
measure: Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
timeFrame: Baseline, Week 4 and Week 12
measure: Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
timeFrame: Baseline, Week 4 and Week 12
measure: Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
timeFrame: Baseline, Week 4 and Week 12
measure: Device Characteristics Based on Response to Question Concerning Look of Device
timeFrame: Baseline, Week 4 and Week 12
measure: Device Characteristics Based on Response to Question Concerning Feel of Device
timeFrame: Baseline, Week 4 and Week 12
measure: Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
timeFrame: Baseline, Week 4 and Week 12
measure: Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
timeFrame: Baseline, Week 4 and Week 12
measure: Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
timeFrame: Baseline, Week 4 and Week 12
measure: Influence of Age on Participant Perception
timeFrame: Baseline
measure: Influence of Gender on Participant Perception
timeFrame: Baseline
measure: Influence of Socio-educational Status on Participant Perception
timeFrame: Baseline
measure: Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
timeFrame: Baseline
measure: Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception
timeFrame: Baseline
measure: Influence of Prior Injection Experience on Participant Perception
timeFrame: Baseline
measure: Influence of Prior Self-injection Experience on Participant Perception
timeFrame: Baseline
measure: Influence of Duration of Psoriasis on Participant Perception
timeFrame: Baseline
measure: Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception
timeFrame: Baseline
measure: Influence of Psoriasis Area Severity Index (PASI) on Participant Perception
timeFrame: Baseline
measure: Influence of Participant's Assessment of General Health on Participant Perception
timeFrame: Baseline
measure: Influence of Participant's Global Assessment of Psoriasis on Participant Perception
timeFrame: Baseline
measure: Influence of Dermatology Life Quality Index (DLQI) on Participant Perception
timeFrame: Baseline
measure: Influence of Co-morbidities on Participant Perception
timeFrame: Baseline
measure: Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
timeFrame: Baseline
Other outcomes:
Locations:
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: Kapellen
country: Belgium
city: Liège 1
country: Belgium
city: Hellerup
country: Denmark
city: Hørsholm
country: Denmark
city: Roskilde
country: Denmark
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Joensuu
country: Finland
city: Tampere
country: Finland
city: Le Mans
country: France
state: Cedex
city: Limoges
country: France
city: Montpellier
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Paris
country: France
city: Pessac
country: France
city: Pierre Bénite
country: France
city: Reims
country: France
city: Toulouse
country: France
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Duelmen
country: Germany
city: Erlangen
country: Germany
city: Freiburg
country: Germany
city: Goettingen
country: Germany
city: Greifswald
country: Germany
city: Hamburg
country: Germany
city: Koeln
country: Germany
city: Luebeck
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
city: Tübingen
country: Germany
city: Wiesbaden
country: Germany
city: Wuerzburg
country: Germany
city: Wuerzburg
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Thessaloniki
country: Greece
city: Szeged
country: Hungary
city: S. Giovanni Rotondo
country: Italy
state: Foggia
city: Terracina
country: Italy
state: Latina
city: Gallarate
country: Italy
state: Varese
city: Capranica
country: Italy
state: Viterbo
city: Bologna
country: Italy
city: Como
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Pisa
country: Italy
city: Breda
country: Netherlands
city: Nijmegen
country: Netherlands
city: Vlissingen
country: Netherlands
city: Bergen
country: Norway
city: Stavanger
country: Norway
city: Tromso
country: Norway
city: Elche
country: Spain
state: Alicante
city: Santander
country: Spain
state: Cantabria
city: Córdoba
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Danderyd
country: Sweden
city: Göteborg
country: Sweden
city: Linköping
country: Sweden
city: Malmö
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: