Clinical trial NCT00459706: Study Comparing 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 Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-12
Enrollment: 640
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: The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

Detailed description: This study describes 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, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews.

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, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).

Eligibility criteria: Inclusion:

* Diagnosis of RA according to the ACR-Criteria.
* Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
* Willing and able to self-inject etanercept.

Exclusion:

* Prior experience of biologics and anti-TNF treatment for their RA including etanercept.
* Sepsis or risk of sepsis.
* Current or recent infections, including chronic or localized.

Primary outcomes:
measure: Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population
timeFrame: Day 84
measure: Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population
timeFrame: Day 84
Secondary outcomes:
measure: Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept
timeFrame: Day 28
measure: Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept
timeFrame: Day 84
measure: Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score
timeFrame: Day 84
measure: Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?
timeFrame: Day 84
measure: Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?
timeFrame: Day 84
measure: Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84
timeFrame: Day 84
measure: Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84
timeFrame: Day 84
measure: Age Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Male Participants Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Female Participants Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants at University Level Associated With Participant Perception
timeFrame: Day 84
measure: HAD Anxiety Subscale Score Associated With Participant Perception
timeFrame: Day 84
measure: HAD Depression Subscale Score Associated With Participant Perception
timeFrame: Day 84
measure: PAM Score Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants With Prior Injection Experience Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception
timeFrame: Day 84
measure: RA Duration Associated With Participant Perception
timeFrame: Day 84
measure: DAS28 Score Associated With Participant Perception
timeFrame: Day 84
measure: Participant's Global Assessment of RA Activity Associated With Participant Perception
timeFrame: Day 84
measure: Physician's Global Assessment of RA Activity Associated With Participant Perception
timeFrame: Day 84
measure: HAQ-DI Score Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception
timeFrame: Day 84
measure: Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception
timeFrame: Day 84
measure: Participant Satisfaction at Endpoint Associated With Participant Perception
timeFrame: Day 84
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
city: Hjorring
country: Denmark
city: Holbaek
country: Denmark
city: Silkeborg
country: Denmark
city: Helsinki
country: Finland
city: Hyvinkaa
country: Finland
city: Joensuu
country: Finland
city: Lohja
country: Finland
city: Amiens
country: France
city: Aulnay-sous-Bois
country: France
city: Avignon
country: France
city: Boulogne Billancourt
country: France
city: Brest
country: France
city: Cahors
country: France
city: Corbeilles-Essonnes
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Niort
country: France
city: Orléans
country: France
city: Paris
country: France
city: Paris
country: France
city: Pierre-Bénite
country: France
city: Reims
country: France
city: Rouen
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-Nancy
country: France
city: Erlangen
country: Germany
state: Bay
city: Frankfurt
country: Germany
state: Hessen
city: Pirna
country: Germany
state: Sachsen
city: Bad Abbach
country: Germany
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Duesseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Goettingen
country: Germany
city: Hannover
country: Germany
city: Hannover
country: Germany
city: Hofheim/Taunus
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Muenchen
country: Germany
city: Nienburg
country: Germany
city: Oberammergau
country: Germany
city: Osnabrueck
country: Germany
city: Tübingen
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Wuerzburg
country: Germany
city: Zeven
country: Germany
city: Ariano Irpino
country: Italy
state: Avellino
city: S. Pietro Vernotico
country: Italy
state: Brescia
city: San Cesario di Lecce
country: Italy
state: Lecce
city: Alessandria
country: Italy
city: Bologna
country: Italy
city: Cagliari
country: Italy
city: Cinisello Balsamo
country: Italy
city: Como
country: Italy
city: Coppito
country: Italy
city: Fano
country: Italy
city: Ferrara
country: Italy
city: Foggia
country: Italy
city: Massa
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Parma
country: Italy
city: Reggio Calabria
country: Italy
city: Rieti
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: S. Dona di Piave
country: Italy
city: Terni
country: Italy
city: Torino
country: Italy
city: Torrette di Ancona
country: Italy
city: Verona
country: Italy
city: Vimercate
country: Italy
city: Arnhem
country: Netherlands
city: Eindhoven
country: Netherlands
city: Rotterdam
country: Netherlands
city: Gjettum
country: Norway
city: Harstad
country: Norway
city: Kristiansand
country: Norway
city: Lillehammer
country: Norway
city: Skien
country: Norway
city: Trondheim
country: Norway
city: Tønsberg
country: Norway
city: Danderyd
country: Sweden
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Uppsala
country: Sweden
city: Vasterås
country: Sweden
city: Västerås
country: Sweden
city: Ashford
country: United Kingdom
city: Basingstoke
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Chertsey
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Portsmouth
country: United Kingdom
city: Southampton
country: United Kingdom
city: Stoke on Trent
country: United Kingdom
city: Truro
country: United Kingdom
city: Westcliff on Sea
country: United Kingdom
city: Wigan
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: