Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875991
• Other study ID #: 20090176
• Status: Completed
• Phase: Phase 4
• Start date: June 5, 2013
• Est. completion date: March 4, 2014

Study information

• Verified date: August 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.

Description:

Candidates for treatment are those who in the determination of the investigator's standard of care and the caring physician's intent are to initiate treatment with etanercept. Participants must be naïve to etanercept and naïve to other autoinjector pens or prefilled syringes and be able to self-inject. The study will consist of a 30 day screening period, and 2 treatment periods of 4 weeks duration each (one treatment period using Autoinjector A and the other using Autoinjector B). At the end of the study, participants may continue treatment with commercially available etanercept at the physician's discretion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 4, 2014
• Est. primary completion date: March 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Diagnosis of moderate to severe Rheumatoid Arthritis (RA) or moderate to severe Plaque Psoriasis (PsO) and a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. - Naive to etanercept. - Naive to other autoinjector pens or prefilled syringes for Tumor Necrosis Factor (TNF)-inhibitor therapy or other subcutaneous biologics for RA. - Willing to self-inject per investigator judgement at screening and capable of self-injection using the autoinjector A or B as documented at baseline by the investigator. - Able to read and write in English. -

Exclusion Criteria: Latex allergy. - Subject has an active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept. - Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening.

• Other criteria may apply.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Plaque Psoriasis
• Psoriasis
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept via Autoinjector A
Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.
• Etanercept via Autoinjector B
Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.

Locations

Country	Name	City	State
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Peterborough	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Victoria	British Columbia
United States	Research Site	Austin	Texas
United States	Research Site	Bismarck	North Dakota
United States	Research Site	Charleston	South Carolina
United States	Research Site	Clarksburg	West Virginia
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Dunedin	Florida
United States	Research Site	Frederick	Maryland
United States	Research Site	Glendale	Arizona
United States	Research Site	Hixson	Tennessee
United States	Research Site	Hot Springs	Arkansas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Lansing	Michigan
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Louisville	Kentucky
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orchard Park	New York
United States	Research Site	Overland Park	Kansas
United States	Research Site	San Diego	California
United States	Research Site	San Ramon	California
United States	Research Site	Santa Maria	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Tampa	Florida
United States	Research Site	Tuscaloosa	Alabama
United States	Research Site	Tustin	California
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B	Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question "Which autoinjector do you prefer overall?"	Week 8
Secondary	Change From Baseline in Needle Apprehension at Week 4	Participants' needle apprehension was assessed using the Subject's Perception of Self-Injecting Questionnaire. Participants answered the question "Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector" using a scale from 1 (extremely nervous) to 5 (not at all nervous).	Baseline and Week 4
Secondary	Ease of Use	Ease of use was assessed based on responses to questions 1 to 6 of the Subject's Experience with the Autoinjector Questionnaire: 1. How easy was it to learn how to use the autoinjector? 2. How easy was it for you to press the button to start the injection? 3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection? 5. How easy was it for you to inject yourself using the autoinjector? 6. How easy was it to follow the progress of the injection? Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy). The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.	At the end of each treatment period; Week 4 and Week 8
Secondary	Certainty of Completing the Injection With the Autoinjector	Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject's Experience with the Autoinjector Questionnaire: "How certain were you that you knew when the injection was finished?" Participants answered on a scale from 1 (Not at all) to 5 (Extremely). The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported.	At the end of each treatment period; Week 4 and Week 8
Secondary	Convenience	Convenience was assessed based on responses to Question 8 of the Subject's Experience with the Autoinjector Questionnaire: "How convenient was the autoinjector to use?" Participants answered on a scale from 1 (Not at all) to 5 (Very much). The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported.	At the end of each treatment period; Week 4 and Week 8
Secondary	Discomfort	Discomfort was assessed based on responses to Question 9 of the Subject's Experience with the Autoinjector Questionnaire: "How much discomfort did you experience when giving yourself the medicine using the autoinjector?" Participants answered on a scale from 1 (None) to 5 (Very much). The percentage of participants who scored a 1 (None) or 2 (A little) is reported.	At the end of each treatment period; Week 4 and Week 8
Secondary	Satisfaction	Satisfaction was assessed based on responses to questions 11 and 12 of the Subject's Experience with the Autoinjector Questionnaire. Question 11: "How dependable (durable, sturdy, reliable) did you feel the autoinjector device was?" answered on a scale from 1 (Not at all) to 5 (Very much). Question 12: "Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept?" answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend). The percentage of participants who scored either a 4 or 5 on each question is reported.	At the end of each treatment period; Week 4 and Week 8
Secondary	Pain Associated With Use of the Autoinjector	Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject's Experience with the Autoinjector Questionnaire: "Using this scale, select the circle that best describes how much it hurt when giving yourself an injection." Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst). The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported.	At the end of each treatment period; Week 4 and Week 8
Secondary	Strength of Preference for Autoinjector A and Autoinjector B	Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8. After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).	Week 8

External Links

•   AmgenTrials clinical trials website