Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01875991
Recruitment Status : Completed
First Posted : June 12, 2013
Results First Posted : May 20, 2015
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Rheumatoid Arthritis
Plaque Psoriasis
Interventions Drug: Etanercept via Autoinjector A
Drug: Etanercept via Autoinjector B
Enrollment 217
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.
Arm/Group Title Autoinjector A / Autoinjector B Autoinjector B / Autoinjector A
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 108 109
Received Etanercept in Period 1 108 108
Received Etanercept in Period 2 102 103
Completed 101 103
Not Completed 7 6
Reason Not Completed
Withdrawal by Subject             6             6
Sponsor Decision             1             0
Arm/Group Title Autoinjector A / Autoinjector B Autoinjector B / Autoinjector A Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 108 109 217
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 109 participants 217 participants
55.9  (13.8) 53.2  (13.6) 54.6  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
Female
74
  68.5%
74
  67.9%
148
  68.2%
Male
34
  31.5%
35
  32.1%
69
  31.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
American Indian or Alaska Native 1 0 1
Asian 1 2 3
Black or African American 5 3 8
White 100 102 202
Other 1 2 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
Hispanic or Latino 9 10 19
Not Hispanic or Latino 99 99 198
Disease State  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
Rheumatoid Arthritis 79 78 157
Plaque Psoriasis 29 31 60
1.Primary Outcome
Title Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Primary Analysis Set
Hide Arm/Group Description:
Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
Overall Number of Participants Analyzed 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Overall
41.7
(34.9 to 48.4)
Rheumatoid Arthritis (N=147)
43.5
(35.5 to 51.6)
Plaque Psoriasis (N=57)
36.8
(24.3 to 49.4)
2.Secondary Outcome
Title Change From Baseline in Needle Apprehension at Week 4
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, which included all randomized participants. "n" indicates the number of participants with available data.
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
Overall Number of Participants Analyzed 108 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=108, 109) 3.94  (0.96) 4.00  (1.02)
Change from Baseline (n= 102, 106) 0.31  (1.01) 0.39  (0.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autoinjector A, Autoinjector B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments [Not Specified]
Method Van Elteren test
Comments P-value for 'All subjects' from Van Elteren test adjusting for strata (RA or PsO)
3.Secondary Outcome
Title Ease of Use
Hide 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 At the end of each treatment period; Week 4 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 207
Measure Type: Number
Unit of Measure: percentage of participants
Ease of learning how to use the autoinjector 92.3 96.1
Ease of pressing button to start the autoinjector 95.7 90.8
Ease of using the autoinjector 91.3 88.9
Ease of holding the autoinjector 89.4 88.4
Ease of self-injecting 88.0 87.0
Ease of following progress 94.2 87.4
4.Secondary Outcome
Title Certainty of Completing the Injection With the Autoinjector
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 206
Measure Type: Number
Unit of Measure: percentage of participants
94.2 87.9
5.Secondary Outcome
Title Convenience
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 207
Measure Type: Number
Unit of Measure: percentage of participants
76.9 86.5
6.Secondary Outcome
Title Discomfort
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 207
Measure Type: Number
Unit of Measure: percentage of participants
56.3 72.5
7.Secondary Outcome
Title Satisfaction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 207
Measure Type: Number
Unit of Measure: percentage of participants
How dependable did you feel 79.8 86.0
Likeliness of recommending autoinjector 66.8 84.5
8.Secondary Outcome
Title Pain Associated With Use of the Autoinjector
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 207
Measure Type: Number
Unit of Measure: percentage of participants
51.4 65.2
9.Secondary Outcome
Title Strength of Preference for Autoinjector A and Autoinjector B
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Analysis Set
Arm/Group Title Autoinjector A Preference Autoinjector B Preference
Hide Arm/Group Description:
Participants who preferred Autoinjector A overall
Participants who preferred Autoinjector B overall
Overall Number of Participants Analyzed 85 119
Measure Type: Number
Unit of Measure: percentage of participants
Very Strongly 45.9 36.1
Strongly 43.5 41.2
Somewhat 5.9 16.8
Slightly 4.7 5.9
Time Frame 12 weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Autoinjector A Autoinjector B
Hide Arm/Group 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.
All-Cause Mortality
Autoinjector A Autoinjector B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Autoinjector A Autoinjector B
Affected / at Risk (%) Affected / at Risk (%)
Total   9/211 (4.27%)   2/210 (0.95%) 
Cardiac disorders     
Atrial flutter  1  1/211 (0.47%)  0/210 (0.00%) 
Gastrointestinal disorders     
Impaired gastric emptying  1  1/211 (0.47%)  0/210 (0.00%) 
Infections and infestations     
Gastroenteritis  1  0/211 (0.00%)  1/210 (0.48%) 
Pneumonia  1  1/211 (0.47%)  0/210 (0.00%) 
Pyelonephritis  1  1/211 (0.47%)  0/210 (0.00%) 
Injury, poisoning and procedural complications     
Gun shot wound  1  1/211 (0.47%)  0/210 (0.00%) 
Vascular pseudoaneurysm  1  1/211 (0.47%)  0/210 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/211 (0.47%)  0/210 (0.00%) 
Leiomyosarcoma  1  1/211 (0.47%)  0/210 (0.00%) 
Psychiatric disorders     
Conversion disorder  1  1/211 (0.47%)  0/210 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/211 (0.47%)  0/210 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/211 (0.47%)  0/210 (0.00%) 
Haematoma  1  1/211 (0.47%)  0/210 (0.00%) 
Hypotension  1  0/211 (0.00%)  1/210 (0.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Autoinjector A Autoinjector B
Affected / at Risk (%) Affected / at Risk (%)
Total   12/211 (5.69%)   6/210 (2.86%) 
General disorders     
Injection site erythema  1  12/211 (5.69%)  6/210 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01875991    
Other Study ID Numbers: 20090176
First Submitted: June 10, 2013
First Posted: June 12, 2013
Results First Submitted: March 3, 2015
Results First Posted: May 20, 2015
Last Update Posted: September 4, 2018