Trial Outcomes & Findings for Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept (NCT NCT01875991)
NCT ID: NCT01875991
Last Updated: 2018-09-04
Results Overview
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?"
COMPLETED
PHASE4
217 participants
Week 8
2018-09-04
Participant Flow
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.
Randomization was stratified by disease state (RA and PsO). Each participant served as his or her own control in this crossover study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
109
|
|
Overall Study
Received Etanercept in Period 1
|
108
|
108
|
|
Overall Study
Received Etanercept in Period 2
|
102
|
103
|
|
Overall Study
COMPLETED
|
101
|
103
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
Baseline Characteristics
Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept
Baseline characteristics by cohort
| Measure |
Autoinjector A / Autoinjector B
n=108 Participants
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.
|
Autoinjector B / Autoinjector A
n=109 Participants
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.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 13.8 • n=39 Participants
|
53.2 years
STANDARD_DEVIATION 13.6 • n=41 Participants
|
54.6 years
STANDARD_DEVIATION 13.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
148 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=39 Participants
|
2 participants
n=41 Participants
|
3 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=39 Participants
|
3 participants
n=41 Participants
|
8 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
100 participants
n=39 Participants
|
102 participants
n=41 Participants
|
202 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=39 Participants
|
2 participants
n=41 Participants
|
3 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 participants
n=39 Participants
|
10 participants
n=41 Participants
|
19 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
99 participants
n=39 Participants
|
99 participants
n=41 Participants
|
198 participants
n=35 Participants
|
|
Disease State
Rheumatoid Arthritis
|
79 participants
n=39 Participants
|
78 participants
n=41 Participants
|
157 participants
n=35 Participants
|
|
Disease State
Plaque Psoriasis
|
29 participants
n=39 Participants
|
31 participants
n=41 Participants
|
60 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: 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.
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?"
Outcome measures
| Measure |
Primary Analysis Set
n=204 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
Overall
|
41.7 percentage of participants
Interval 34.9 to 48.4
|
—
|
|
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
Rheumatoid Arthritis (N=147)
|
43.5 percentage of participants
Interval 35.5 to 51.6
|
—
|
|
Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
Plaque Psoriasis (N=57)
|
36.8 percentage of participants
Interval 24.3 to 49.4
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Full analysis set, which included all randomized participants. "n" indicates the number of participants with available data.
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).
Outcome measures
| Measure |
Primary Analysis Set
n=108 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=109 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Needle Apprehension at Week 4
Baseline (n=108, 109)
|
3.94 units on a scale
Standard Deviation 0.96
|
4.00 units on a scale
Standard Deviation 1.02
|
|
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
|
0.39 units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: At the end of each treatment period; Week 4 and Week 8Population: Full analysis set with available data
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.
Outcome measures
| Measure |
Primary Analysis Set
n=208 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=207 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Ease of Use
Ease of learning how to use the autoinjector
|
92.3 percentage of participants
|
96.1 percentage of participants
|
|
Ease of Use
Ease of pressing button to start the autoinjector
|
95.7 percentage of participants
|
90.8 percentage of participants
|
|
Ease of Use
Ease of using the autoinjector
|
91.3 percentage of participants
|
88.9 percentage of participants
|
|
Ease of Use
Ease of holding the autoinjector
|
89.4 percentage of participants
|
88.4 percentage of participants
|
|
Ease of Use
Ease of self-injecting
|
88.0 percentage of participants
|
87.0 percentage of participants
|
|
Ease of Use
Ease of following progress
|
94.2 percentage of participants
|
87.4 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of each treatment period; Week 4 and Week 8Population: Full analysis set with available data
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.
Outcome measures
| Measure |
Primary Analysis Set
n=208 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=206 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Certainty of Completing the Injection With the Autoinjector
|
94.2 percentage of participants
|
87.9 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of each treatment period; Week 4 and Week 8Population: Full analysis set with available data
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.
Outcome measures
| Measure |
Primary Analysis Set
n=208 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=207 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Convenience
|
76.9 percentage of participants
|
86.5 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of each treatment period; Week 4 and Week 8Population: Full analysis set with available data
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.
Outcome measures
| Measure |
Primary Analysis Set
n=208 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=207 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Discomfort
|
56.3 percentage of participants
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of each treatment period; Week 4 and Week 8Population: Full analysis set with available data
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.
Outcome measures
| Measure |
Primary Analysis Set
n=208 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=207 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Satisfaction
How dependable did you feel
|
79.8 percentage of participants
|
86.0 percentage of participants
|
|
Satisfaction
Likeliness of recommending autoinjector
|
66.8 percentage of participants
|
84.5 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of each treatment period; Week 4 and Week 8Population: Full analysis set with available data
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.
Outcome measures
| Measure |
Primary Analysis Set
n=208 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=207 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Pain Associated With Use of the Autoinjector
|
51.4 percentage of participants
|
65.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Primary Analysis Set
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).
Outcome measures
| Measure |
Primary Analysis Set
n=85 Participants
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
|
Autoinjector B
n=119 Participants
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Strength of Preference for Autoinjector A and Autoinjector B
Very Strongly
|
45.9 percentage of participants
Interval 34.9 to 48.4
|
36.1 percentage of participants
|
|
Strength of Preference for Autoinjector A and Autoinjector B
Strongly
|
43.5 percentage of participants
Interval 35.5 to 51.6
|
41.2 percentage of participants
|
|
Strength of Preference for Autoinjector A and Autoinjector B
Somewhat
|
5.9 percentage of participants
Interval 24.3 to 49.4
|
16.8 percentage of participants
|
|
Strength of Preference for Autoinjector A and Autoinjector B
Slightly
|
4.7 percentage of participants
|
5.9 percentage of participants
|
Adverse Events
Autoinjector A
Autoinjector B
Serious adverse events
| Measure |
Autoinjector A
n=211 participants at risk
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
|
Autoinjector B
n=210 participants at risk
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.48%
1/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Conversion disorder
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haematoma
|
0.47%
1/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.00%
0/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.48%
1/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Autoinjector A
n=211 participants at risk
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
|
Autoinjector B
n=210 participants at risk
Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
|
|---|---|---|
|
General disorders
Injection site erythema
|
5.7%
12/211 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
6/210 • 12 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER