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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00459706
Date of registration:	11/04/2007
Prospective Registration:	Yes
Primary sponsor:	Pfizer
Public title:	Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Scientific 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
Date of first enrolment:	September 2007
Target sample size:	640
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00459706
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Denmark	Finland	France	Germany	Italy	Netherlands	Norway	Sweden
United Kingdom

Contacts

Name:	Medical Monitor
Address:
Telephone:
Email:
Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Device: Enbrel 50 mg Autoinjector

Device: Enbrel 50 mg Prefilled Syringe

Primary Outcome(s)

Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population [Time Frame: Day 84]

Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population [Time Frame: Day 84]

Secondary Outcome(s)

HAQ-DI Score Associated With Participant Perception [Time Frame: Day 84]

Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Participant's Global Assessment of RA Activity Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept [Time Frame: Day 84]

HAD Anxiety Subscale Score Associated With Participant Perception [Time Frame: Day 84]

Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84 [Time Frame: Day 84]

Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84 [Time Frame: Day 84]

Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept [Time Frame: Day 28]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84 [Time Frame: Day 84]

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA? [Time Frame: Day 84]

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole? [Time Frame: Day 84]

Age Associated With Participant Perception [Time Frame: Day 84]

Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

DAS28 Score Associated With Participant Perception [Time Frame: Day 84]

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health? [Time Frame: Day 84]

Participant Satisfaction at Endpoint Associated With Participant Perception [Time Frame: Day 84]

Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84 [Time Frame: Day 84]

PAM Score Associated With Participant Perception [Time Frame: Day 84]

Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84 [Time Frame: Day 84]

Percentage of Male Participants Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants at University Level Associated With Participant Perception [Time Frame: Day 84]

Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84 [Time Frame: Day 84]

Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84 [Time Frame: Day 84]

HAD Depression Subscale Score Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84 [Time Frame: Day 84]

Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84 [Time Frame: Day 84]

Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants With Prior Injection Experience Associated With Participant Perception [Time Frame: Day 84]

Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score [Time Frame: Day 84]

Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception [Time Frame: Day 84]

Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception [Time Frame: Day 84]

Physician's Global Assessment of RA Activity Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84 [Time Frame: Day 84]

Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84 [Time Frame: Day 84]

RA Duration Associated With Participant Perception [Time Frame: Day 84]

Percentage of Female Participants Associated With Participant Perception [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84 [Time Frame: Day 84]

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84 [Time Frame: Day 84]

Secondary ID(s)

B1801017

0881K1-6000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	28/03/2013
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00459706

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