Plaque Psoriasis, Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGEtanercept 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.
DRUGEtanercept via Autoinjector B
Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B | Week 8 | 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
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use | At the end of each treatment period; Week 4 and Week 8 | 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 | At the end of each treatment period; Week 4 and Week 8 | 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 | At the end of each treatment period; Week 4 and Week 8 | 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. |
| Change From Baseline in Needle Apprehension at Week 4 | Baseline and 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). |
| Satisfaction | At the end of each treatment period; Week 4 and Week 8 | 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 | At the end of each treatment period; Week 4 and Week 8 | 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 | Week 8 | 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). |
| Discomfort | At the end of each treatment period; Week 4 and Week 8 | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Adults (≥ 18 years) with moderate to severe rheumatoid arthritis (RA) or plaque psoriasis (PsO) and candidates for treatment with etanercept (Enbrel) in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept. First patient enrolled on 05 June 2013; last patient enrolled 03 January 2014.
Pre-assignment details
Randomization was stratified by disease state (RA and PsO). Each participant served as his or her own control in this crossover study.
Participants by arm
| Arm | Count |
|---|---|
| Autoinjector A / Autoinjector B Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment. | 108 |
| Autoinjector B / Autoinjector A Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment. | 109 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Sponsor Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Autoinjector A / Autoinjector B | Autoinjector B / Autoinjector A | Total |
|---|---|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 13.8 | 53.2 years STANDARD_DEVIATION 13.6 | 54.6 years STANDARD_DEVIATION 13.7 |
| Disease State Plaque Psoriasis | 29 participants | 31 participants | 60 participants |
| Disease State Rheumatoid Arthritis | 79 participants | 78 participants | 157 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Black or African American | 5 participants | 3 participants | 8 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 participants | 10 participants | 19 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 99 participants | 99 participants | 198 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized White | 100 participants | 102 participants | 202 participants |
| Sex: Female, Male Female | 74 Participants | 74 Participants | 148 Participants |
| Sex: Female, Male Male | 34 Participants | 35 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 211 | 6 / 210 |
| serious Total, serious adverse events | 9 / 211 | 2 / 210 |
Outcome results
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?
Time frame: Week 8
Population: The primary analysis set consisted of all randomized participants who received at least 1 injection of Eetanercept with each autoinjector and indicated a preference for an autoinjector in the Subject Preference Questionnaire. N = number of participants with RA and PsO respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set | Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B | Overall | 41.7 percentage of participants |
| Primary Analysis Set | Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B | Rheumatoid Arthritis (N=147) | 43.5 percentage of participants |
| Primary Analysis Set | Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B | Plaque Psoriasis (N=57) | 36.8 percentage of participants |
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.
Time frame: At the end of each treatment period; Week 4 and Week 8
Population: Full analysis set with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Analysis Set | Certainty of Completing the Injection With the Autoinjector | 94.2 percentage of participants |
| Autoinjector B | Certainty of Completing the Injection With the Autoinjector | 87.9 percentage of participants |
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).
Time frame: Baseline and Week 4
Population: Full analysis set, which included all randomized participants. n indicates the number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Analysis Set | Change From Baseline in Needle Apprehension at Week 4 | Baseline (n=108, 109) | 3.94 units on a scale | Standard Deviation 0.96 |
| Primary Analysis Set | Change From Baseline in Needle Apprehension at Week 4 | Change from Baseline (n= 102, 106) | 0.31 units on a scale | Standard Deviation 1.01 |
| Autoinjector B | Change From Baseline in Needle Apprehension at Week 4 | Baseline (n=108, 109) | 4.00 units on a scale | Standard Deviation 1.02 |
| Autoinjector B | Change From Baseline in Needle Apprehension at Week 4 | Change from Baseline (n= 102, 106) | 0.39 units on a scale | Standard Deviation 0.91 |
p-value: 0.501Van Elteren test
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.
Time frame: At the end of each treatment period; Week 4 and Week 8
Population: Full analysis set with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Analysis Set | Convenience | 76.9 percentage of participants |
| Autoinjector B | Convenience | 86.5 percentage of participants |
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.
Time frame: At the end of each treatment period; Week 4 and Week 8
Population: Full analysis set with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Analysis Set | Discomfort | 56.3 percentage of participants |
| Autoinjector B | Discomfort | 72.5 percentage of participants |
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.
Time frame: At the end of each treatment period; Week 4 and Week 8
Population: Full analysis set with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set | Ease of Use | Ease of pressing button to start the autoinjector | 95.7 percentage of participants |
| Primary Analysis Set | Ease of Use | Ease of holding the autoinjector | 89.4 percentage of participants |
| Primary Analysis Set | Ease of Use | Ease of self-injecting | 88.0 percentage of participants |
| Primary Analysis Set | Ease of Use | Ease of learning how to use the autoinjector | 92.3 percentage of participants |
| Primary Analysis Set | Ease of Use | Ease of following progress | 94.2 percentage of participants |
| Primary Analysis Set | Ease of Use | Ease of using the autoinjector | 91.3 percentage of participants |
| Autoinjector B | Ease of Use | Ease of following progress | 87.4 percentage of participants |
| Autoinjector B | Ease of Use | Ease of learning how to use the autoinjector | 96.1 percentage of participants |
| Autoinjector B | Ease of Use | Ease of pressing button to start the autoinjector | 90.8 percentage of participants |
| Autoinjector B | Ease of Use | Ease of using the autoinjector | 88.9 percentage of participants |
| Autoinjector B | Ease of Use | Ease of self-injecting | 87.0 percentage of participants |
| Autoinjector B | Ease of Use | Ease of holding the autoinjector | 88.4 percentage of participants |
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.
Time frame: At the end of each treatment period; Week 4 and Week 8
Population: Full analysis set with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Analysis Set | Pain Associated With Use of the Autoinjector | 51.4 percentage of participants |
| Autoinjector B | Pain Associated With Use of the Autoinjector | 65.2 percentage of participants |
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.
Time frame: At the end of each treatment period; Week 4 and Week 8
Population: Full analysis set with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set | Satisfaction | How dependable did you feel | 79.8 percentage of participants |
| Primary Analysis Set | Satisfaction | Likeliness of recommending autoinjector | 66.8 percentage of participants |
| Autoinjector B | Satisfaction | How dependable did you feel | 86.0 percentage of participants |
| Autoinjector B | Satisfaction | Likeliness of recommending autoinjector | 84.5 percentage of participants |
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).
Time frame: Week 8
Population: Primary Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Set | Strength of Preference for Autoinjector A and Autoinjector B | Very Strongly | 45.9 percentage of participants |
| Primary Analysis Set | Strength of Preference for Autoinjector A and Autoinjector B | Strongly | 43.5 percentage of participants |
| Primary Analysis Set | Strength of Preference for Autoinjector A and Autoinjector B | Somewhat | 5.9 percentage of participants |
| Primary Analysis Set | Strength of Preference for Autoinjector A and Autoinjector B | Slightly | 4.7 percentage of participants |
| Autoinjector B | Strength of Preference for Autoinjector A and Autoinjector B | Slightly | 5.9 percentage of participants |
| Autoinjector B | Strength of Preference for Autoinjector A and Autoinjector B | Very Strongly | 36.1 percentage of participants |
| Autoinjector B | Strength of Preference for Autoinjector A and Autoinjector B | Somewhat | 16.8 percentage of participants |
| Autoinjector B | Strength of Preference for Autoinjector A and Autoinjector B | Strongly | 41.2 percentage of participants |