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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Etanercept via Autoinjector A

Etanercept via Autoinjector B

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Autoinjector A

Autoinjector B

Arm Description

Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.

Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

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).

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.

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.

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.

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.

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.

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.

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).

Full Information

NCT ID

NCT01875991

First Posted

June 10, 2013

Last Updated

August 1, 2018

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01875991

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

June 5, 2013 (Actual)

Primary Completion Date

March 4, 2014 (Actual)

Study Completion Date

March 4, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

217 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autoinjector A

Arm Type

Experimental

Arm Description

Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.

Arm Title

Autoinjector B

Arm Type

Experimental

Arm Description

Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Etanercept via Autoinjector A

Intervention Description

Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.

Intervention Type

Drug

Intervention Name(s)

Etanercept via Autoinjector B

Other Intervention Name(s)

Enbrel® SureClick®

Intervention Description

Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.

Primary Outcome Measure Information:

Title

Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B

Description

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?"

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Change From Baseline in Needle Apprehension at Week 4

Description

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).

Time Frame

Baseline and Week 4

Title

Ease of Use

Description

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.

Time Frame