Psoriasis
Conditions
Brief summary
Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.
Detailed description
For the measures of patient's satisfaction with and perceptions of, their device, standard Likert scales are used. This allows the magnitude of individual's perceptions and satisfaction to be measured on a multipoint scale anchored at each end. In addition, the study will describe patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, injection site pain, injection anxiety, injection confidence) will be captured using a questionnaire. The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, demographics, social and educational status psychological status, willingness to self-manage, injection experience) and Psoriasis characteristics (e.g. disease severity, disease duration, co morbidities, prior treatment, quality of life). The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices.
Interventions
DEVICEEnbrel (etanercept)
Arm 1 = Enbrel 50 mg Prefilled Syringe twice weekly
DEVICEEtanercept
Arm 2 = Enbrel 50 mg Autoinjector twice weekly
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA * Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines. * Aged 18 years or more * Willing and able to self-inject etanercept. * Able to store test drug at 2-8oC. * Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study. * Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.
Exclusion criteria
* Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept. * Sepsis or risk of sepsis. * Current or recent infections, including chronic or localized. * Latex sensitivity. * Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population | Week 12 | Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied. |
| Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population | Week 12 | Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of Gender on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female. |
| Influence of Socio-educational Status on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level. |
| Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =\< 4, \> 4 to 7, \> 7 to 10, \> 10 for HAD-A and =\< 3, \> 3 to 5, \> 5 to 8, \> 8 for HAD-D. |
| Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =\< 47.4, \> 47.4 to 56.4, \> 56.4 to 68.5, \> 68.5. |
| Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no. |
| Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =\< 11 years, \> 11 years to 19 years, \> 19 years to 28 years, \> 28 years. |
| Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =\< 3, \> 3 to 4, \> 4. |
| Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =\< 11.2, \> 11.2 to 16.2, \> 16.2 to 21.9, \> 21.9. |
| Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =\< 48, \> 48 to 67.25, \> 67.25 to 84, \> 84. |
| Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =\< 63, \> 63 to 76, \> 76 to 88, \> 88. |
| Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =\< 8, \> 8 to 13, \> 13 to 18, \> 18. |
| Influence of Co-morbidities on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage. |
| Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no. |
| Influence of Prior Injection Experience on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no. |
| Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline, Week 4 and Week 12 | Ease of use of injection device was assessed by participant's response to question, How easy was it to perform an injection with this device? scored on a 5-point Likert scale (0= very easy to 4= very difficult). |
| Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline, Week 4 and Week 12 | Ease of use of injection device was assessed by participant's response to question, How easy was it to use the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult). |
| Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline, Week 4 and Week 12 | Ease of use of injection device was assessed by participant's response to question, How easy was it to dispose of the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult). |
| Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline, Week 4 and Week 12 | Ease of use of injection device was assessed by participant's response to question, How easy is it to know when the injection is completed? scored on a 5-point Likert scale (0= very easy to 4= very difficult). |
| Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline, Week 4 and Week 12 | Ease of use of injection device was assessed by participant's response to question, How easy is it to hold the device whilst injecting? scored on a 5-point Likert scale (0= very easy to 4= very difficult) |
| Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline, Week 4 and Week 12 | Ease of use of injection device was assessed by participant's response to question, Did you feel any hand discomfort whilst using the device? scored on a 5-point Likert scale (0= none to 4= extreme). |
| Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline, Week 4 and Week 12 | Ease of Use of Injection Device was assessed by participant's response to question, How long does it take to perform the injection, including any preparation and disposal? where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'. |
| Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline, Week 4 and Week 12 | Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline, Week 4 and Week 12 | Convenience of injection device was assessed by participant's response to question, Do you think injecting etanercept will interfere with your usual daily activities? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline, Week 4 and Week 12 | Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline, Week 4 and Week 12 | Confidence in injection device was assessed by participant's response to question, How confident are you in your management of your injections? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline, Week 4 and Week 12 | Confidence in injection device was assessed by participant's response to question, How confident are you that you inject the right amount of medicine every time? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline, Week 4 and Week 12 | Confidence in injection device was assessed by participant's response to question, How confident are you that you can inject yourself properly with the device? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline, Week 4 and Week 12 | Confidence in injection device was assessed by participant's response to question, Are you confident that you have good control over the injection process? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline, Week 4 and Week 12 | Confidence in injection device was assessed by participant's response to question, How confident are you that you injected yourself successfully? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline, Week 4 and Week 12 | Fear of Device was assessed by participant's response to question, How nervous do you feel about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline, Week 4 and Week 12 | Fear of Device was assessed by participant's response to question, How nervous do you feel about inserting the needle into your skin? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline, Week 4 and Week 12 | Fear of Device was assessed by participant's response to question, Do you dislike injecting yourself with this device? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline, Week 4 and Week 12 | Fear of Device was assessed by participant's response to question, Are you emotionally distressed or anxious about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Device Characteristics Based on Response to Question Concerning Look of Device | Baseline, Week 4 and Week 12 | Device characteristics were assessed by participant's response to question, How much do you like the look of the device? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline, Week 4 and Week 12 | Device characteristics were assessed by participant's response to question, How much do you like the feel of the device? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline, Week 4 and Week 12 | Device characteristics were assessed by participant's response to question, How much does the device look like something you would feel comfortable to use? scored on a 5-point Likert scale (0= not at all to 4= very much). |
| Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline, Week 4 and Week 12 | Side effects related to administration were assessed by participant's response to question, Do you experience pain during or immediately after the injection? scored on a 5-point Likert scale (0= none to 4= severe). |
| Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Baseline, Week 4 and Week 12 | SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety. |
| Influence of Age on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants. |
| Influence of Gender on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants. |
| Influence of Socio-educational Status on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants. |
| Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Baseline | Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants. |
| Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Baseline | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants. |
| Influence of Prior Injection Experience on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants. |
| Influence of Prior Self-injection Experience on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants. |
| Influence of Duration of Psoriasis on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants. |
| Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants. |
| Percentage of Participants Satisfied With Injection Device | Baseline, Week 4 and Week 12 | Participant satisfaction was assessed by asking the question Are you satisfied with your injection device? and using a dichotomous response: Yes or No. |
| Influence of Participant's Assessment of General Health on Participant Perception | Baseline | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants. |
| Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Baseline | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants. |
| Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Baseline | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants. |
| Influence of Co-morbidities on Participant Perception | Baseline | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants. |
| Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Baseline | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants. |
| Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Baseline | Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants. |
| Influence of Age on Participant Satisfaction With Injection Device | Week 12 | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=\<) 36 years, greater than (\>) 36 years to 45 years, \> 45 years to 55 years, \> 55 years. |
Countries
Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Spain, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept 50 mg Auto-injector Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | 206 |
| Etanercept 50 mg Prefilled Syringe Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. | 211 |
| Total | 417 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 14 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Unspecified reason | 0 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | Etanercept 50 mg Auto-injector | Etanercept 50 mg Prefilled Syringe | Total |
|---|---|---|---|
| Age Continuous | 46.1 years STANDARD_DEVIATION 13.2 | 46.1 years STANDARD_DEVIATION 13.4 | 46.1 years STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 71 Participants | 65 Participants | 136 Participants |
| Sex: Female, Male Male | 135 Participants | 146 Participants | 281 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 94 / 207 | 96 / 211 |
| serious Total, serious adverse events | 6 / 207 | 5 / 211 |
Outcome results
Primary
Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population
Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Time frame: Week 12
Population: Per-protocol (PP) analysis population included participants from mITT population who completed the study with no major protocol violations. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population | 9.0 units on a scale | Standard Deviation 1.9 |
| Etanercept 50 mg Prefilled Syringe | Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population | 7.5 units on a scale | Standard Deviation 2.6 |
Comparison: ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.p-value: <0.00195% CI: [0.95, 1.87]ANOVA
Primary
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Time frame: Week 12
Population: Modified intent-to-treat (mITT) analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population | 8.9 units on a scale | Standard Deviation 1.9 |
| Etanercept 50 mg Prefilled Syringe | Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population | 7.6 units on a scale | Standard Deviation 2.6 |
Comparison: Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.p-value: <0.00195% CI: [0.87, 1.77]ANOVA
Secondary
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Fear of Device was assessed by participant's response to question, Do you dislike injecting yourself with this device? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 0 | 129 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 1 | 43 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 2 | 22 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 3 | 10 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 4 | 2 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 0 | 135 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 1 | 42 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 2 | 15 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 3 | 0 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 4 | 2 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 0 | 143 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 1 | 39 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 2 | 13 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 3 | 1 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 4 | 3 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 0 | 150 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 1 | 39 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 2 | 13 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 3 | 1 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 4 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 2 | 30 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 0 | 103 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 0 | 112 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 1 | 40 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 0 | 119 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 2 | 29 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 1 | 39 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 3 | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 4 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Baseline- After the training: 4 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 2 | 28 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 0 | 96 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 1 | 43 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 1 | 52 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 3 | 11 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 2 | 33 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Last observation: 3 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 3 | 11 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 12: 4 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Week 4: 4 | 9 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.32, 2.83]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.78, 3.87]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.42, 3.19]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.52, 3.39]Regression, Logistic
Secondary
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Fear of Device was assessed by participant's response to question, Are you emotionally distressed or anxious about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 0 | 124 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 1 | 45 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 2 | 28 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 3 | 7 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 4 | 2 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 0 | 124 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 1 | 57 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 2 | 11 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 3 | 2 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 4 | 1 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 0 | 143 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 1 | 41 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 2 | 12 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 3 | 1 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 4 | 1 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 0 | 149 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 1 | 42 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 2 | 13 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 3 | 1 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 4 | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 2 | 25 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 0 | 105 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 0 | 125 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 1 | 57 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 0 | 134 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 2 | 26 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 1 | 42 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 3 | 11 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 4 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Baseline- After the training: 4 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 2 | 24 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 0 | 119 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 1 | 45 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 1 | 50 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 3 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 2 | 21 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Last observation: 3 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 3 | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 12: 4 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Week 4: 4 | 2 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.05795% CI: [0.99, 2.11]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.15195% CI: [0.9, 1.96]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.02495% CI: [1.06, 2.44]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.02595% CI: [1.06, 2.39]Regression, Logistic
Secondary
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Fear of Device was assessed by participant's response to question, How nervous do you feel about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 0 | 125 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 1 | 59 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 1 | 53 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 4 | 10 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 2 | 17 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 0 | 92 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 3 | 4 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 0 | 110 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 4 | 0 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 2 | 29 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 0 | 131 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 1 | 54 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 1 | 53 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 3 | 7 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 2 | 18 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 2 | 22 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 3 | 4 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 4 | 3 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 4 | 0 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 3 | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 4 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 3 | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 0 | 80 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 1 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 2 | 39 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 3 | 24 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Baseline- After the training: 4 | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 0 | 103 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 1 | 51 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 4 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 0 | 111 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 1 | 46 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 2 | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 3 | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 12: 4 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 0 | 119 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 1 | 48 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 2 | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Last observation: 3 | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Week 4: 2 | 27 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.0995% CI: [0.95, 1.95]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.15495% CI: [0.9, 1.91]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.03795% CI: [1.02, 2.22]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.02895% CI: [1.05, 2.24]Regression, Logistic
Secondary
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Fear of Device was assessed by participant's response to question, How nervous do you feel about inserting the needle into your skin? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 0 | 102 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 1 | 44 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 2 | 32 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 3 | 17 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 4 | 10 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 0 | 110 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 1 | 61 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 2 | 13 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 3 | 10 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 4 | 1 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 0 | 115 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 1 | 59 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 2 | 19 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 3 | 6 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 4 | 0 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 0 | 121 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 1 | 59 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 2 | 20 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 3 | 6 participants |
| Etanercept 50 mg Auto-injector | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 4 | 0 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 2 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 0 | 82 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 0 | 105 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 1 | 49 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 0 | 112 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 2 | 38 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 1 | 47 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 3 | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 4 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Baseline- After the training: 4 | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 2 | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 0 | 93 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 1 | 52 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 1 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 3 | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 2 | 29 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Last observation: 3 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 3 | 18 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 12: 4 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Week 4: 4 | 7 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.02295% CI: [1.06, 2.21]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.00595% CI: [1.17, 2.41]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.07695% CI: [0.97, 2.03]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.04995% CI: [1, 2.11]Regression, Logistic
Secondary
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Confidence in injection device was assessed by participant's response to question, Are you confident that you have good control over the injection process? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 2 | 8 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 3 | 49 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 4 | 131 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 0 | 6 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 2 | 6 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 3 | 43 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 4 | 141 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 0 | 6 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 2 | 8 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 3 | 45 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 4 | 144 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 0 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 1 | 2 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 2 | 11 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 3 | 72 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 4 | 113 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 0 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 3 | 56 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 1 | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 1 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 2 | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 1 | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 3 | 62 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 2 | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 4 | 122 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 4: 0 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 3 | 59 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 1 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 2 | 21 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 2 | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 4 | 135 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 3 | 52 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 4 | 117 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Week 12: 4 | 127 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Baseline- After the training: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Last observation: 0 | 2 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.62895% CI: [0.62, 1.33]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.20395% CI: [0.51, 1.15]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.22295% CI: [0.51, 1.17]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.26395% CI: [0.53, 1.19]Regression, Logistic
Secondary
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Confidence in injection device was assessed by participant's response to question, How confident are you that you injected yourself successfully? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 0 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 0 | 5 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 3 | 69 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 2 | 1 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 3 | 55 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 2 | 16 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 4 | 135 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 2 | 5 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 0 | 5 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 4 | 115 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 3 | 60 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 2 | 2 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 1 | 2 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 3 | 58 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 4 | 124 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 4 | 138 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 0 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 4 | 140 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 0 | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 1 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 2 | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 3 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Baseline- After the training: 4 | 122 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 1 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 2 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 3 | 52 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 4: 4 | 132 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 1 | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 2 | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 3 | 49 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Week 12: 4 | 132 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 1 | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 2 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Last observation: 3 | 53 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.91495% CI: [0.7, 1.5]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.82795% CI: [0.7, 1.57]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.71295% CI: [0.61, 1.4]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.73395% CI: [0.62, 1.39]Regression, Logistic
Secondary
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Confidence in injection device was assessed by participant's response to question, How confident are you that you can inject yourself properly with the device? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 0 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 2 | 12 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 3 | 70 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 4 | 117 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 0 | 6 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 1 | 0 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 2 | 7 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 3 | 47 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 4 | 135 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 0 | 9 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 1 | 1 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 2 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 3 | 43 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 4 | 142 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 0 | 9 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 1 | 1 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 2 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 3 | 47 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 4 | 145 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 2 | 13 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 0 | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 1 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 2 | 27 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 1 | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 3 | 53 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 4 | 130 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Baseline- After the training: 4 | 116 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 2 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 0 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 1 | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 1 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 3 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 2 | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Last observation: 3 | 60 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 3 | 65 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 12: 4 | 123 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Week 4: 4 | 118 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.49495% CI: [0.6, 1.28]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.03695% CI: [0.44, 0.97]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.07995% CI: [0.45, 1.04]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.06395% CI: [0.46, 1.02]Regression, Logistic
Secondary
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Confidence in injection device was assessed by participant's response to question, How confident are you that you inject the right amount of medicine every time? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 2 | 19 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 0 | 7 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 0 | 5 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 1 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 1 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 2 | 7 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 1 | 3 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 3 | 48 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 3 | 67 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 2 | 8 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 0 | 7 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 0 | 5 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 1 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 3 | 53 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 2 | 8 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 4 | 111 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 3 | 52 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 4 | 126 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 4 | 135 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 4 | 132 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 4 | 148 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 1 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 2 | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 3 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Baseline- After the training: 4 | 129 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 0 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 1 | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 2 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 3 | 50 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 4: 4 | 139 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 1 | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 2 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 3 | 43 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Week 12: 4 | 139 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 0 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 1 | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 2 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Last observation: 3 | 47 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.09895% CI: [0.94, 2.03]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.31195% CI: [0.82, 1.87]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.37695% CI: [0.79, 1.85]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.29995% CI: [0.83, 1.86]Regression, Logistic
Secondary
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Confidence in injection device was assessed by participant's response to question, How confident are you in your management of your injections? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 0 | 6 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 1 | 13 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 2 | 30 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 3 | 76 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 4 | 81 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 0 | 4 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 1 | 9 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 2 | 6 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 3 | 56 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 4 | 121 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 0 | 9 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 1 | 5 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 2 | 7 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 3 | 47 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 4 | 131 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 0 | 9 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 1 | 5 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 2 | 7 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 3 | 49 participants |
| Etanercept 50 mg Auto-injector | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 4 | 136 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 2 | 13 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 0 | 11 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 0 | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 1 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 0 | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 2 | 31 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 1 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 3 | 78 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 4 | 122 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Baseline- After the training: 4 | 67 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 2 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 0 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 1 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 1 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 3 | 60 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 2 | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Last observation: 3 | 67 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 3 | 75 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 12: 4 | 117 participants |
| Etanercept 50 mg Prefilled Syringe | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Week 4: 4 | 105 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.06595% CI: [0.5, 1.02]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.195% CI: [0.5, 1.06]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.29895% CI: [0.54, 1.21]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.14895% CI: [0.51, 1.11]Regression, Logistic
Secondary
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 0 | 116 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 1 | 34 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 2 | 30 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 3 | 11 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 4 | 12 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 0 | 145 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 1 | 32 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 2 | 6 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 3 | 8 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 4 | 5 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 0 | 133 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 1 | 44 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 2 | 8 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 3 | 4 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 4 | 6 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 0 | 139 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 1 | 46 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 2 | 8 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 3 | 5 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 4 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 2 | 17 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 0 | 134 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 0 | 131 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 1 | 37 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 0 | 144 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 2 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 1 | 33 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 3 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 4 | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Baseline- After the training: 4 | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 2 | 17 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 0 | 138 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 1 | 34 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 1 | 34 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 3 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 2 | 14 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Last observation: 3 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 3 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 12: 4 | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Week 4: 4 | 7 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.07295% CI: [0.48, 1.03]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.20595% CI: [0.86, 2.03]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.43495% CI: [0.78, 1.78]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.85795% CI: [0.69, 1.55]Regression, Logistic
Secondary
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 0 | 105 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 1 | 48 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 2 | 34 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 3 | 13 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 4 | 3 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 0 | 101 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 1 | 46 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 2 | 34 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 3 | 9 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 4 | 3 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 0 | 109 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 1 | 44 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 2 | 33 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 3 | 5 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 4 | 4 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 0 | 115 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 1 | 46 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 2 | 34 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 3 | 7 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 4 | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 2 | 37 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 0 | 98 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 0 | 101 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 1 | 55 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 0 | 111 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 2 | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 1 | 40 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 3 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 4 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Baseline- After the training: 4 | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 2 | 36 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 0 | 107 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 1 | 43 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 1 | 37 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 3 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 2 | 33 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Last observation: 3 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 3 | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 12: 4 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Week 4: 4 | 10 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.35695% CI: [0.83, 1.69]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.73795% CI: [0.73, 1.56]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.15695% CI: [0.9, 1.91]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.2995% CI: [0.85, 1.76]Regression, Logistic
Secondary
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Convenience of injection device was assessed by participant's response to question, Do you think injecting etanercept will interfere with your usual daily activities? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 2 | 14 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 4 | 2 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 4 | 3 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 0 | 147 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 1 | 45 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 0 | 150 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 3 | 0 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 1 | 35 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 4 | 2 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 1 | 40 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 0 | 155 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 2 | 4 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 1 | 42 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 2 | 6 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 2 | 7 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 3 | 6 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 3 | 0 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 3 | 3 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 4 | 2 participants |
| Etanercept 50 mg Auto-injector | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 0 | 134 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 4 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 0 | 145 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 0 | 137 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 1 | 45 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 1 | 39 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 2 | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 3 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Baseline- After the training: 4 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 1 | 37 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 2 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 3 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 4: 4 | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 0 | 137 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 2 | 13 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 3 | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Week 12: 4 | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 0 | 148 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 1 | 40 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 2 | 13 participants |
| Etanercept 50 mg Prefilled Syringe | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Last observation: 3 | 4 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.83795% CI: [0.7, 1.56]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.17295% CI: [0.87, 2.15]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.09695% CI: [0.94, 2.24]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.16495% CI: [0.88, 2.08]Regression, Logistic
Secondary
Device Characteristics Based on Response to Question Concerning Feel of Device
Device characteristics were assessed by participant's response to question, How much do you like the feel of the device? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 1 | 9 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 0 | 1 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 1 | 9 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 2 | 69 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 3 | 78 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 4 | 49 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 0 | 2 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 1 | 7 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 2 | 58 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 3 | 71 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 4 | 55 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 0 | 4 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 2 | 46 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 3 | 76 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 4 | 64 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 0 | 4 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 1 | 9 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 2 | 49 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 3 | 77 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 4 | 67 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 4 | 31 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 0 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 4 | 30 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 0 | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 2 | 94 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 1 | 24 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 0 | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 2 | 92 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 1 | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 3 | 60 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 4 | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Baseline- After the training: 4 | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 2 | 87 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 0 | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 1 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 1 | 21 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 12: 3 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 2 | 90 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Last observation: 3 | 58 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Feel of Device | Week 4: 3 | 45 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.27, 0.54]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.21, 0.46]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.24, 0.5]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.24, 0.5]Regression, Logistic
Secondary
Device Characteristics Based on Response to Question Concerning Look of Device
Device characteristics were assessed by participant's response to question, How much do you like the look of the device? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 0 | 4 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 1 | 10 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 2 | 62 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 3 | 81 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 4 | 49 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 0 | 3 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 1 | 2 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 2 | 51 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 3 | 79 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 4 | 58 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 0 | 1 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 1 | 11 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 2 | 43 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 3 | 78 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 4 | 66 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 0 | 1 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 1 | 11 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 2 | 46 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 3 | 79 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 4 | 69 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 2 | 82 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 0 | 18 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 0 | 13 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 1 | 21 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 0 | 14 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 2 | 90 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 1 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 3 | 56 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 4 | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Baseline- After the training: 4 | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 2 | 77 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 0 | 14 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 1 | 21 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 1 | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 3 | 59 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 2 | 92 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Last observation: 3 | 62 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 3 | 46 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 12: 4 | 29 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Concerning Look of Device | Week 4: 4 | 27 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.24, 0.49]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.18, 0.37]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.21, 0.45]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.23, 0.47]Regression, Logistic
Secondary
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Device characteristics were assessed by participant's response to question, How much does the device look like something you would feel comfortable to use? scored on a 5-point Likert scale (0= not at all to 4= very much).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 0 | 7 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 1 | 11 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 2 | 68 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 3 | 67 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 4 | 53 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 0 | 6 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 1 | 8 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 2 | 51 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 3 | 69 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 4 | 59 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 0 | 7 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 1 | 15 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 2 | 47 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 3 | 65 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 4 | 65 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 0 | 7 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 1 | 16 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 2 | 47 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 3 | 67 participants |
| Etanercept 50 mg Auto-injector | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 4 | 69 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 2 | 68 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 0 | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 0 | 27 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 1 | 26 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 0 | 27 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 2 | 76 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 1 | 21 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 3 | 55 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 4 | 36 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Baseline- After the training: 4 | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 2 | 62 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 0 | 28 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 1 | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 1 | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 3 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 2 | 74 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Last observation: 3 | 58 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 3 | 45 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 12: 4 | 34 participants |
| Etanercept 50 mg Prefilled Syringe | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Week 4: 4 | 32 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.24, 0.46]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.22, 0.46]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.26, 0.56]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [0.28, 0.58]Regression, Logistic
Secondary
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Ease of use of injection device was assessed by participant's response to question, How easy was it to dispose of the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 2 (n=173, 189) | 5 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 0 (n=198, 205) | 158 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 1 (n=198, 205) | 25 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 2 (n=198, 205) | 12 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 3 (n=198, 205) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 4 (n=198, 205) | 0 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 0 (n=173, 189) | 131 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 1 (n=173, 189) | 29 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 3 (n=173, 189) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 4 (n=173, 189) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 0 (n=187, 195) | 150 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 1 (n=187, 195) | 21 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 2 (n=187, 195) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 3 (n=187, 195) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 4 (n=187, 195) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 0 (n=202, 210) | 161 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 1 (n=202, 210) | 23 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 2 (n=202, 210) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 3 (n=202, 210) | 5 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 4 (n=202, 210) | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 2 (n=202, 210) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 0 (n=187, 195) | 148 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 0 (n=198, 205) | 141 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 0 (n=202, 210) | 161 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 1 (n=198, 205) | 47 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 1 (n=187, 195) | 34 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 2 (n=198, 205) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 4 (n=202, 210) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 3 (n=198, 205) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 2 (n=187, 195) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Baseline- After the training: 4 (n=198, 205) | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 1 (n=202, 210) | 36 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 0 (n=173, 189) | 142 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 3 (n=187, 195) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 1 (n=173, 189) | 34 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 2 (n=173, 189) | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Last observation: 3 (n=202, 210) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 3 (n=173, 189) | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 12: 4 (n=187, 195) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Week 4: 4 (n=173, 189) | 3 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.02595% CI: [1.07, 2.64]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.93695% CI: [0.63, 1.64]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.4295% CI: [0.75, 1.99]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.62595% CI: [0.71, 1.79]Regression, Logistic
Secondary
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Ease of use of injection device was assessed by participant's response to question, How easy is it to hold the device whilst injecting? scored on a 5-point Likert scale (0= very easy to 4= very difficult)
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 0 (n=199, 206) | 134 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 1 (n=199, 206) | 48 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 2 (n=199, 206) | 15 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 3 (n=199, 206) | 2 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 4 (n=199, 206) | 0 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 0 (n=179, 190) | 114 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 1 (n=179, 190) | 45 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 2 (n=179, 190) | 14 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 3 (n=179, 190) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 4 (n=179, 190) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 0 (n=193, 196) | 133 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 1 (n=193, 196) | 51 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 2 (n=193, 196) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 3 (n=193, 196) | 1 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 4 (n=193, 196) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 0 (n=203, 209) | 140 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 1 (n=203, 209) | 52 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 2 (n=203, 209) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 3 (n=203, 209) | 1 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 4 (n=203, 209) | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 2 (n=203, 209) | 29 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 0 (n=199, 206) | 100 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 0 (n=193, 196) | 101 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 1 (n=199, 206) | 72 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 0 (n=203, 209) | 105 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 2 (n=199, 206) | 24 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 1 (n=193, 196) | 55 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 3 (n=199, 206) | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 4 (n=203, 209) | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Baseline- After the training: 4 (n=199, 206) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 2 (n=193, 196) | 27 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 0 (n=179, 190) | 83 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 1 (n=203, 209) | 61 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 1 (n=179, 190) | 59 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 3 (n=193, 196) | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 2 (n=179, 190) | 33 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Last observation: 3 (n=203, 209) | 11 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 3 (n=179, 190) | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 12: 4 (n=193, 196) | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Week 4: 4 (n=179, 190) | 3 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.48, 3.21]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.62, 3.62]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.58, 3.51]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.64, 3.59]Regression, Logistic
Secondary
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Ease of use of injection device was assessed by participant's response to question, How easy is it to know when the injection is completed? scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 0 (n=201, 207) | 140 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 1 (n=201, 207) | 44 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 2 (n=201, 207) | 13 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 3 (n=201, 207) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 4 (n=201, 207) | 1 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 0 (n=175, 189) | 124 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 1 (n=175, 189) | 40 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 2 (n=175, 189) | 5 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 3 (n=175, 189) | 2 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 4 (n=175, 189) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 0 (n=194, 192) | 147 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 1 (n=194, 192) | 40 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 2 (n=194, 192) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 3 (n=194, 192) | 0 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 4 (n=194, 192) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 0 (n=204, 210) | 155 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 1 (n=204, 210) | 42 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 2 (n=204, 210) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 3 (n=204, 210) | 0 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 4 (n=204, 210) | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 2 (n=204, 210) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 0 (n=201, 207) | 129 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 0 (n=194, 192) | 137 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 1 (n=201, 207) | 62 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 0 (n=204, 210) | 151 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 2 (n=201, 207) | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 1 (n=194, 192) | 38 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 3 (n=201, 207) | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 4 (n=204, 210) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Baseline- After the training: 4 (n=201, 207) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 2 (n=194, 192) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 0 (n=175, 189) | 123 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 1 (n=204, 210) | 42 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 1 (n=175, 189) | 50 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 3 (n=194, 192) | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 2 (n=175, 189) | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Last Observation: 3 (n=204, 210) | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 3 (n=175, 189) | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 12: 4 (n=194, 192) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Week 4: 4 (n=175, 189) | 3 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.2195% CI: [0.86, 1.94]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.22795% CI: [0.85, 2.03]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.2295% CI: [0.84, 2.08]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.24995% CI: [0.84, 2]Regression, Logistic
Secondary
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Ease of use of injection device was assessed by participant's response to question, How easy was it to use the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 0 (n=201, 208) | 154 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 1 (n=201, 208) | 39 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 2 (n=201, 208) | 7 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 3 (n=201, 208) | 1 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 4 (n=201, 208) | 0 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 0 (n=179, 189) | 137 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 1 (n=179, 189) | 32 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 2 (n=179, 189) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 3 (n=179, 189) | 1 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 4 (n=179, 189) | 5 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 0 (n=189, 195) | 154 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 1 (n=189, 195) | 26 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 2 (n=189, 195) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 3 (n=189, 195) | 2 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 4 (n=189, 195) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 0 (n=201, 207) | 161 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 1 (n=201, 207) | 26 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 2 (n=201, 207) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 3 (n=201, 207) | 5 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 4 (n=201, 207) | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 2 (n=201, 207) | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 0 (n=201, 208) | 132 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 0 (n=189, 195) | 126 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 1 (n=201, 208) | 57 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 0 (n=201, 207) | 134 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 2 (n=201, 208) | 13 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 1 (n=189, 195) | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 3 (n=201, 208) | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 4 (n=201, 207) | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Baseline- After the training: 4 (n=201, 208) | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 2 (n=189, 195) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 0 (n=179, 189) | 122 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 1 (n=201, 207) | 57 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 1 (n=179, 189) | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 3 (n=189, 195) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 2 (n=179, 189) | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Last observation: 3 (n=201, 207) | 2 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 3 (n=179, 189) | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 12: 4 (n=189, 195) | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Week 4: 4 (n=179, 189) | 3 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.00495% CI: [1.22, 2.89]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.01795% CI: [1.1, 2.72]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.47, 3.73]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.00195% CI: [1.32, 3.21]Regression, Logistic
Secondary
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Ease of use of injection device was assessed by participant's response to question, Did you feel any hand discomfort whilst using the device? scored on a 5-point Likert scale (0= none to 4= extreme).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 0 (n=197, 208) | 158 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 1 (n=197, 208) | 26 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 2 (n=197, 208) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 3 (n=197, 208) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 4 (n=197, 208) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 0 (n=176, 188) | 144 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 1 (n=176, 188) | 18 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 2 (n=176, 188) | 7 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 3 (n=176, 188) | 7 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 4 (n=176, 188) | 0 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 0 (n=193, 195) | 159 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 1 (n=193, 195) | 24 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 2 (n=193, 195) | 7 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 3 (n=193, 195) | 2 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 4 (n=193, 195) | 1 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 0 (n=204, 210) | 168 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 1 (n=204, 210) | 25 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 2 (n=204, 210) | 8 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 3 (n=204, 210) | 2 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 4 (n=204, 210) | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 2 (n=204, 210) | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 0 (n=197, 208) | 131 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 0 (n=193, 195) | 125 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 1 (n=197, 208) | 44 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 0 (n=204, 210) | 138 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 2 (n=197, 208) | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 1 (n=193, 195) | 45 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 3 (n=197, 208) | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 4 (n=204, 210) | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Baseline- After the training: 4 (n=197, 208) | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 2 (n=193, 195) | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 0 (n=176, 188) | 114 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 1 (n=204, 210) | 46 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 1 (n=176, 188) | 37 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 3 (n=193, 195) | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 2 (n=176, 188) | 26 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Last observation: 3 (n=204, 210) | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 3 (n=176, 188) | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 12: 4 (n=193, 195) | 3 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Week 4: 4 (n=176, 188) | 3 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.5, 3.65]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.83, 4.77]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.62, 4.12]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.55, 3.86]Regression, Logistic
Secondary
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Ease of use of injection device was assessed by participant's response to question, How easy was it to perform an injection with this device? scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 0 (n=202, 208) | 134 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 1 (n=202, 208) | 50 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 2 (n=202, 208) | 15 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 3 (n=202, 208) | 3 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 4 (n=202, 208) | 0 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 0 (n=180, 190) | 126 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 1 (n=180, 190) | 42 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 2 (n=180, 190) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 3 (n=180, 190) | 2 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 4 (n=180, 190) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 0 (n=194, 195) | 149 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 1 (n=194, 195) | 35 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 2 (n=194, 195) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 3 (n=194, 195) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 4 (n=194, 195) | 2 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 0 (n=202, 207) | 153 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 1 (n=202, 207) | 36 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 2 (n=202, 207) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 3 (n=202, 207) | 5 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 4 (n=202, 207) | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 2 (n=202, 207) | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 0 (n=202, 208) | 92 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 0 (n=194, 195) | 109 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 1 (n=202, 208) | 72 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 0 (n=202, 207) | 115 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 2 (n=202, 208) | 33 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 1 (n=194, 195) | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 3 (n=202, 208) | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 4 (n=202, 207) | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Baseline- After the training: 4 (n=202, 208) | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 2 (n=194, 195) | 18 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 0 (n=180, 190) | 94 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 1 (n=202, 207) | 58 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 1 (n=180, 190) | 62 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 3 (n=194, 195) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 2 (n=180, 190) | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Last observation: 3 (n=202, 207) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 3 (n=180, 190) | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 12: 4 (n=194, 195) | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Week 4: 4 (n=180, 190) | 2 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.63, 3.49]Generalized Estimating Equations
Comparison: Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.61, 3.67]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.78, 4.21]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: <0.00195% CI: [1.66, 3.8]Regression, Logistic
Secondary
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Ease of Use of Injection Device was assessed by participant's response to question, How long does it take to perform the injection, including any preparation and disposal? where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'.
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: less than 5 (n=200, 206) | 132 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: 5 to10 (n=200, 206) | 43 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: 11 to 20 (n=200, 206) | 12 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: 21 to 30 (n=200, 206) | 9 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training:more than 30 (n=200, 206) | 4 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: less than 5 (n=180, 189) | 117 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: 5 to 10 (n=180, 189) | 36 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: 11 to 20 (n=180, 189) | 14 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: 21 to 30 (n=180, 189) | 8 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: more than 30 (n=180, 189) | 5 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: less than 5 (n=192, 196) | 124 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: 5 to 10 (n=192, 196) | 44 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: 11 to 20 (n=192, 196) | 12 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: 21 to 30 (n=192, 196) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: more than 30 (n=192, 196) | 6 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: less than 5 (n=204, 210) | 131 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: 5 to 10 (n=204, 210) | 48 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: 11 to 20 (n=204, 210) | 12 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: 21 to 30 (n=204, 210) | 7 participants |
| Etanercept 50 mg Auto-injector | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: more than 30 (n=204, 210) | 6 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: 11 to 20 (n=204, 210) | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: less than 5 (n=200, 206) | 129 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: less than 5 (n=192, 196) | 132 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: 5 to10 (n=200, 206) | 56 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: less than 5 (n=204, 210) | 143 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: 11 to 20 (n=200, 206) | 14 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: 5 to 10 (n=192, 196) | 40 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training: 21 to 30 (n=200, 206) | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: more than 30 (n=204, 210) | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Baseline- After training:more than 30 (n=200, 206) | 0 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: 11 to 20 (n=192, 196) | 12 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: less than 5 (n=180, 189) | 121 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: 5 to 10 (n=204, 210) | 43 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: 5 to 10 (n=180, 189) | 41 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: 21 to 30 (n=192, 196) | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: 11 to 20 (n=180, 189) | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Last observation: 21 to 30 (n=204, 210) | 7 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: 21 to 30 (n=180, 189) | 10 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 12: more than 30 (n=192, 196) | 5 participants |
| Etanercept 50 mg Prefilled Syringe | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Week 4: more than 30 (n=180, 189) | 1 participants |
Comparison: Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.68195% CI: [0.73, 1.62]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.94795% CI: [0.67, 1.54]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.60495% CI: [0.59, 1.36]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.4395% CI: [0.57, 1.27]Regression, Logistic
Secondary
Influence of Age on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Age on Participant Perception | Very satisfied (n=119, 92) | 47.9 years | Standard Deviation 12.6 |
| Etanercept 50 mg Auto-injector | Influence of Age on Participant Perception | Satisfied (n= 56, 65) | 42.8 years | Standard Deviation 12.9 |
| Etanercept 50 mg Auto-injector | Influence of Age on Participant Perception | Less satisfied (n= 20, 41) | 42.7 years | Standard Deviation 15.4 |
| Etanercept 50 mg Prefilled Syringe | Influence of Age on Participant Perception | Very satisfied (n=119, 92) | 49.1 years | Standard Deviation 12.7 |
| Etanercept 50 mg Prefilled Syringe | Influence of Age on Participant Perception | Satisfied (n= 56, 65) | 43.9 years | Standard Deviation 13.3 |
| Etanercept 50 mg Prefilled Syringe | Influence of Age on Participant Perception | Less satisfied (n= 20, 41) | 42.5 years | Standard Deviation 14.4 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.p-value: 0.03ANOVA
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.p-value: 0.01ANOVA
Secondary
Influence of Age on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=\<) 36 years, greater than (\>) 36 years to 45 years, \> 45 years to 55 years, \> 55 years.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Last observation carried forward (LOCF) method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Age on Participant Satisfaction With Injection Device | =< 36 years | 8.94 units on a scale | Standard Deviation 1.95 |
| Etanercept 50 mg Auto-injector | Influence of Age on Participant Satisfaction With Injection Device | > 36 years to 45 years | 8.91 units on a scale | Standard Deviation 1.52 |
| Etanercept 50 mg Auto-injector | Influence of Age on Participant Satisfaction With Injection Device | > 45 years to 55 years | 9.06 units on a scale | Standard Deviation 1.89 |
| Etanercept 50 mg Auto-injector | Influence of Age on Participant Satisfaction With Injection Device | > 55 years | 8.82 units on a scale | Standard Deviation 2.12 |
| Etanercept 50 mg Prefilled Syringe | Influence of Age on Participant Satisfaction With Injection Device | > 55 years | 8.07 units on a scale | Standard Deviation 2.49 |
| Etanercept 50 mg Prefilled Syringe | Influence of Age on Participant Satisfaction With Injection Device | =< 36 years | 7.18 units on a scale | Standard Deviation 2.62 |
| Etanercept 50 mg Prefilled Syringe | Influence of Age on Participant Satisfaction With Injection Device | > 45 years to 55 years | 7.93 units on a scale | Standard Deviation 2.9 |
| Etanercept 50 mg Prefilled Syringe | Influence of Age on Participant Satisfaction With Injection Device | > 36 years to 45 years | 7.41 units on a scale | Standard Deviation 2.39 |
Comparison: Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.04595% CI: [0, 0.34]Regression, Linear
Secondary
Influence of Co-morbidities on Participant Perception
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Very satisfied: Tobacco usage- No (n=119, 92) | 70 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Satisfied: Alcohol usage- Yes (n= 56, 65) | 20 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Very satisfied: Alcohol usage- No (n=119, 92) | 60 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Satisfied: Alcohol usage- No (n= 56, 65) | 36 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Very satisfied: Tobacco usage- Yes (n=119, 92) | 49 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Less satisfied: Tobacco usage- Yes (n= 20, 41) | 8 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Satisfied: Tobacco usage- Yes (n= 56, 65) | 20 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Less satisfied: Tobacco usage- No (n= 20, 41) | 12 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Very satisfied: Alcohol usage- Yes (n=119, 92) | 59 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Less satisfied: Alcohol usage- Yes (n= 20, 41) | 6 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Satisfied: Tobacco usage- No (n= 56, 65) | 36 participants |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Perception | Less satisfied: Alcohol usage- No (n= 20, 41) | 14 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Satisfied: Tobacco usage- No (n= 56, 65) | 40 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Very satisfied: Tobacco usage- Yes (n=119, 92) | 31 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Very satisfied: Tobacco usage- No (n=119, 92) | 61 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Very satisfied: Alcohol usage- Yes (n=119, 92) | 38 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Very satisfied: Alcohol usage- No (n=119, 92) | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Satisfied: Tobacco usage- Yes (n= 56, 65) | 25 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Less satisfied: Alcohol usage- No (n= 20, 41) | 30 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Satisfied: Alcohol usage- Yes (n= 56, 65) | 29 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Satisfied: Alcohol usage- No (n= 56, 65) | 36 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Less satisfied: Tobacco usage- Yes (n= 20, 41) | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Less satisfied: Tobacco usage- No (n= 20, 41) | 22 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Perception | Less satisfied: Alcohol usage- Yes (n= 20, 41) | 11 participants |
Comparison: p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.p-value: 0.787Chi-squared
Comparison: p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.379Chi-squared
Comparison: p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.p-value: 0.098Chi-squared
Comparison: p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.166Chi-squared
Secondary
Influence of Co-morbidities on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current tobacco usage: Yes | 8.94 units on a scale | Standard Deviation 2.11 |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current tobacco usage: No | 8.95 units on a scale | Standard Deviation 1.7 |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current alcohol usage: Yes | 8.96 units on a scale | Standard Deviation 1.93 |
| Etanercept 50 mg Auto-injector | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current alcohol usage: No | 8.94 units on a scale | Standard Deviation 1.84 |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current alcohol usage: No | 7.33 units on a scale | Standard Deviation 2.86 |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current tobacco usage: Yes | 7.40 units on a scale | Standard Deviation 2.6 |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current alcohol usage: Yes | 8.06 units on a scale | Standard Deviation 2.06 |
| Etanercept 50 mg Prefilled Syringe | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Current tobacco usage: No | 7.76 units on a scale | Standard Deviation 2.58 |
Comparison: Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).p-value: 0.53195% CI: [-0.61, 0.32]Regression, Linear
Comparison: Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).p-value: 0.06195% CI: [-0.02, 0.9]Regression, Linear
Secondary
Influence of Dermatology Life Quality Index (DLQI) on Participant Perception
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Very satisfied (n=116, 90) | 13.4 units on a scale | Standard Deviation 6.8 |
| Etanercept 50 mg Auto-injector | Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Satisfied (n= 54, 63) | 12.4 units on a scale | Standard Deviation 6.4 |
| Etanercept 50 mg Auto-injector | Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Less satisfied (n= 18, 41) | 14.6 units on a scale | Standard Deviation 6.9 |
| Etanercept 50 mg Prefilled Syringe | Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Very satisfied (n=116, 90) | 13.1 units on a scale | Standard Deviation 7.1 |
| Etanercept 50 mg Prefilled Syringe | Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Satisfied (n= 54, 63) | 12.8 units on a scale | Standard Deviation 6 |
| Etanercept 50 mg Prefilled Syringe | Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Less satisfied (n= 18, 41) | 13.1 units on a scale | Standard Deviation 6.7 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.444ANOVA
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.947ANOVA
Secondary
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =\< 8, \> 8 to 13, \> 13 to 18, \> 18.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | =< 8 | 8.82 units on a scale | Standard Deviation 2.18 |
| Etanercept 50 mg Auto-injector | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | > 8 to 13 | 8.94 units on a scale | Standard Deviation 1.7 |
| Etanercept 50 mg Auto-injector | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | > 13 to 18 | 8.81 units on a scale | Standard Deviation 2.04 |
| Etanercept 50 mg Auto-injector | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | > 18 | 9.14 units on a scale | Standard Deviation 1.67 |
| Etanercept 50 mg Prefilled Syringe | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | > 18 | 7.55 units on a scale | Standard Deviation 2.87 |
| Etanercept 50 mg Prefilled Syringe | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | =< 8 | 7.82 units on a scale | Standard Deviation 2.23 |
| Etanercept 50 mg Prefilled Syringe | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | > 13 to 18 | 7.37 units on a scale | Standard Deviation 2.72 |
| Etanercept 50 mg Prefilled Syringe | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | > 8 to 13 | 7.71 units on a scale | Standard Deviation 2.53 |
Comparison: Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.96895% CI: [-0.17, 0.17]Regression, Linear
Secondary
Influence of Duration of Psoriasis on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Duration of Psoriasis on Participant Perception | Very satisfied (n=119, 92) | 23.3 years | Standard Deviation 13.3 |
| Etanercept 50 mg Auto-injector | Influence of Duration of Psoriasis on Participant Perception | Satisfied (n= 56, 65) | 17.8 years | Standard Deviation 10 |
| Etanercept 50 mg Auto-injector | Influence of Duration of Psoriasis on Participant Perception | Less satisfied (n= 20, 41) | 16.1 years | Standard Deviation 7.4 |
| Etanercept 50 mg Prefilled Syringe | Influence of Duration of Psoriasis on Participant Perception | Very satisfied (n=119, 92) | 22.9 years | Standard Deviation 12.1 |
| Etanercept 50 mg Prefilled Syringe | Influence of Duration of Psoriasis on Participant Perception | Satisfied (n= 56, 65) | 20.6 years | Standard Deviation 10.8 |
| Etanercept 50 mg Prefilled Syringe | Influence of Duration of Psoriasis on Participant Perception | Less satisfied (n= 20, 41) | 17.1 years | Standard Deviation 9.8 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.004ANOVA
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.024ANOVA
Secondary
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =\< 11 years, \> 11 years to 19 years, \> 19 years to 28 years, \> 28 years.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | =< 11 years | 9.09 units on a scale | Standard Deviation 1.56 |
| Etanercept 50 mg Auto-injector | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | > 11 years to 19 years | 8.74 units on a scale | Standard Deviation 1.99 |
| Etanercept 50 mg Auto-injector | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | > 19 years to 28 years | 9.12 units on a scale | Standard Deviation 1.65 |
| Etanercept 50 mg Auto-injector | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | > 28 years | 8.82 units on a scale | Standard Deviation 2.29 |
| Etanercept 50 mg Prefilled Syringe | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | > 28 years | 7.76 units on a scale | Standard Deviation 2.66 |
| Etanercept 50 mg Prefilled Syringe | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | =< 11 years | 7.90 units on a scale | Standard Deviation 2.22 |
| Etanercept 50 mg Prefilled Syringe | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | > 19 years to 28 years | 7.72 units on a scale | Standard Deviation 2.76 |
| Etanercept 50 mg Prefilled Syringe | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | > 11 years to 19 years | 7.17 units on a scale | Standard Deviation 2.67 |
Comparison: Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.69395% CI: [-0.08, 0.12]Regression, Linear
Secondary
Influence of Gender on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Perception | Very satisfied: Female (n=119, 92) | 42 participants |
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Perception | Satisfied: Female (n= 56, 65) | 19 participants |
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Perception | Very satisfied: Male (n=119, 92) | 77 participants |
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Perception | Less satisfied: Male (n= 20, 41) | 13 participants |
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Perception | Less satisfied: Female (n= 20, 41) | 7 participants |
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Perception | Satisfied: Male (n= 56, 65) | 37 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Perception | Less satisfied: Female (n= 20, 41) | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Perception | Very satisfied: Male (n=119, 92) | 67 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Perception | Very satisfied: Female (n=119, 92) | 25 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Perception | Satisfied: Male (n= 56, 65) | 45 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Perception | Satisfied: Female (n= 56, 65) | 20 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Perception | Less satisfied: Male (n= 20, 41) | 26 participants |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.984Chi-squared
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.549Chi-squared
Secondary
Influence of Gender on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Satisfaction With Injection Device | Male | 9.07 units on a scale | Standard Deviation 1.59 |
| Etanercept 50 mg Auto-injector | Influence of Gender on Participant Satisfaction With Injection Device | Female | 8.70 units on a scale | Standard Deviation 2.31 |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Satisfaction With Injection Device | Male | 7.60 units on a scale | Standard Deviation 2.57 |
| Etanercept 50 mg Prefilled Syringe | Influence of Gender on Participant Satisfaction With Injection Device | Female | 7.68 units on a scale | Standard Deviation 2.66 |
Comparison: Statistical analysis was carried out between categories, female and male (reference).p-value: 0.70795% CI: [-0.58, 0.39]Regression, Linear
Secondary
Influence of Participant's Assessment of General Health on Participant Perception
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Participant's Assessment of General Health on Participant Perception | Very satisfied (n=117, 90) | 64.9 mm | Standard Deviation 23.7 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Assessment of General Health on Participant Perception | Satisfied (n= 55, 65) | 59.3 mm | Standard Deviation 25.3 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Assessment of General Health on Participant Perception | Less satisfied (n= 20, 40) | 48.8 mm | Standard Deviation 31.2 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Assessment of General Health on Participant Perception | Very satisfied (n=117, 90) | 63.8 mm | Standard Deviation 27.9 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Assessment of General Health on Participant Perception | Satisfied (n= 55, 65) | 70.7 mm | Standard Deviation 21.5 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Assessment of General Health on Participant Perception | Less satisfied (n= 20, 40) | 60.5 mm | Standard Deviation 22.7 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.023ANOVA
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.089ANOVA
Secondary
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =\< 48, \> 48 to 67.25, \> 67.25 to 84, \> 84.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | =< 48 | 8.54 units on a scale | Standard Deviation 2.36 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | > 48 to 67.25 | 9.15 units on a scale | Standard Deviation 1.24 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | > 67.25 to 84 | 8.70 units on a scale | Standard Deviation 2.22 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | > 84 | 9.42 units on a scale | Standard Deviation 1.2 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | > 84 | 7.85 units on a scale | Standard Deviation 2.44 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | =< 48 | 7.06 units on a scale | Standard Deviation 3.26 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | > 67.25 to 84 | 7.72 units on a scale | Standard Deviation 2.06 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | > 48 to 67.25 | 7.79 units on a scale | Standard Deviation 2.61 |
Comparison: Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.04595% CI: [0, 0.18]Regression, Linear
Secondary
Influence of Participant's Global Assessment of Psoriasis on Participant Perception
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Very satisfied (n=116, 90) | 73.5 mm | Standard Deviation 17.7 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Satisfied (n= 55, 65) | 69.9 mm | Standard Deviation 19.1 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Less satisfied (n= 20, 39) | 72.6 mm | Standard Deviation 21.2 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Very satisfied (n=116, 90) | 73.4 mm | Standard Deviation 18 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Satisfied (n= 55, 65) | 73.3 mm | Standard Deviation 19.8 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Less satisfied (n= 20, 39) | 70.8 mm | Standard Deviation 26.7 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.494ANOVA
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.782ANOVA
Secondary
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =\< 63, \> 63 to 76, \> 76 to 88, \> 88.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | =< 63 | 8.79 units on a scale | Standard Deviation 1.54 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | > 63 to 76 | 9.02 units on a scale | Standard Deviation 1.91 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | > 76 to 88 | 8.71 units on a scale | Standard Deviation 2.19 |
| Etanercept 50 mg Auto-injector | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | > 88 | 9.20 units on a scale | Standard Deviation 1.9 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | > 88 | 7.33 units on a scale | Standard Deviation 2.78 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | =< 63 | 7.96 units on a scale | Standard Deviation 2.18 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | > 76 to 88 | 7.70 units on a scale | Standard Deviation 2.55 |
| Etanercept 50 mg Prefilled Syringe | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | > 63 to 76 | 7.51 units on a scale | Standard Deviation 2.8 |
Comparison: Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.91395% CI: [-0.12, 0.11]Regression, Linear
Secondary
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Very satisfied (n=119, 92) | 3.0 units on a scale | Full Range 0.8 |
| Etanercept 50 mg Auto-injector | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Satisfied (n= 56, 65) | 3.0 units on a scale | Full Range 0.7 |
| Etanercept 50 mg Auto-injector | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Less satisfied (n= 20, 40) | 3.0 units on a scale | Full Range 0.7 |
| Etanercept 50 mg Prefilled Syringe | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Very satisfied (n=119, 92) | 3.0 units on a scale | Full Range 0.6 |
| Etanercept 50 mg Prefilled Syringe | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Satisfied (n= 56, 65) | 3.0 units on a scale | Full Range 0.8 |
| Etanercept 50 mg Prefilled Syringe | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Less satisfied (n= 20, 40) | 3.0 units on a scale | Full Range 0.8 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.652Kruskal-Wallis
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.024Kruskal-Wallis
Secondary
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =\< 3, \> 3 to 4, \> 4.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | =< 3 | 8.87 units on a scale | Standard Deviation 1.91 |
| Etanercept 50 mg Auto-injector | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | > 3 to 4 | 8.96 units on a scale | Standard Deviation 1.97 |
| Etanercept 50 mg Auto-injector | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | > 4 | 9.62 units on a scale | Standard Deviation 0.51 |
| Etanercept 50 mg Prefilled Syringe | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | =< 3 | 7.51 units on a scale | Standard Deviation 2.48 |
| Etanercept 50 mg Prefilled Syringe | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | > 3 to 4 | 7.79 units on a scale | Standard Deviation 2.79 |
| Etanercept 50 mg Prefilled Syringe | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | > 4 | 7.83 units on a scale | Standard Deviation 3.06 |
Comparison: Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.1795% CI: [-0.09, 0.53]Regression, Linear
Secondary
Influence of Prior Injection Experience on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Perception | Very satisfied: with experience (n=119, 92) | 47 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Perception | Very satisfied: without experience (n=119, 92) | 72 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Perception | Satisfied: with experience (n= 56, 65) | 20 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Perception | Satisfied: without experience (n= 56, 65) | 36 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Perception | Less satisfied: with experience (n= 20, 41) | 9 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Perception | Less satisfied: without experience (n= 20, 41) | 11 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Perception | Less satisfied: with experience (n= 20, 41) | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Perception | Very satisfied: with experience (n=119, 92) | 43 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Perception | Satisfied: without experience (n= 56, 65) | 37 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Perception | Very satisfied: without experience (n=119, 92) | 49 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Perception | Less satisfied: without experience (n= 20, 41) | 25 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Perception | Satisfied: with experience (n= 56, 65) | 28 participants |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.752Chi-squared
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.7Chi-squared
Secondary
Influence of Prior Injection Experience on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Satisfaction With Injection Device | Yes | 9.05 units on a scale | Standard Deviation 1.66 |
| Etanercept 50 mg Auto-injector | Influence of Prior Injection Experience on Participant Satisfaction With Injection Device | No | 8.88 units on a scale | Standard Deviation 2.01 |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Satisfaction With Injection Device | Yes | 7.70 units on a scale | Standard Deviation 2.58 |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Injection Experience on Participant Satisfaction With Injection Device | No | 7.56 units on a scale | Standard Deviation 2.61 |
Comparison: Statistical analysis was carried out between categories, yes and no (reference).p-value: 0.71395% CI: [-0.37, 0.55]Regression, Linear
Secondary
Influence of Prior Self-injection Experience on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Perception | Very satisfied: with experience (n=119, 92) | 23 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Perception | Very satisfied: without experience (n=119, 92) | 96 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Perception | Satisfied: with experience (n= 56, 65) | 13 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Perception | Satisfied: without experience (n= 56, 65) | 43 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Perception | Less satisfied: with experience (n= 20, 41) | 5 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Perception | Less satisfied: without experience (n= 20, 41) | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Perception | Less satisfied: with experience (n= 20, 41) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Perception | Very satisfied: with experience (n=119, 92) | 33 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Perception | Satisfied: without experience (n= 56, 65) | 49 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Perception | Very satisfied: without experience (n=119, 92) | 59 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Perception | Less satisfied: without experience (n= 20, 41) | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Perception | Satisfied: with experience (n= 56, 65) | 16 participants |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.697Fisher Exact
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.159Chi-squared
Secondary
Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device | Yes | 8.89 units on a scale | Standard Deviation 1.92 |
| Etanercept 50 mg Auto-injector | Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device | No | 8.96 units on a scale | Standard Deviation 1.87 |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device | Yes | 7.53 units on a scale | Standard Deviation 2.74 |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device | No | 7.66 units on a scale | Standard Deviation 2.53 |
Comparison: Statistical analysis was carried out between categories, yes and no (reference).p-value: 0.35995% CI: [-0.76, 0.28]Regression, Linear
Secondary
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Very satisfied: Prior medication- Yes (n=119, 92) | 119 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Very satisfied: Prior medication- No (n=119, 92) | 0 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Satisfied: Prior medication- Yes (n= 56, 65) | 56 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Satisfied: Prior medication- No (n= 56, 65) | 0 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Less satisfied: Prior medication- Yes (n= 20, 41) | 20 participants |
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Less satisfied: Prior medication- No (n= 20, 41) | 0 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Less satisfied: Prior medication- Yes (n= 20, 41) | 41 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Very satisfied: Prior medication- Yes (n=119, 92) | 92 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Satisfied: Prior medication- No (n= 56, 65) | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Very satisfied: Prior medication- No (n=119, 92) | 0 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Less satisfied: Prior medication- No (n= 20, 41) | 0 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Satisfied: Prior medication- Yes (n= 56, 65) | 64 participants |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.535Fisher Exact
Secondary
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device | Yes | 8.95 units on a scale | Standard Deviation 1.87 |
| Etanercept 50 mg Auto-injector | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device | No | NA units on a scale | — |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device | Yes | 7.61 units on a scale | Standard Deviation 2.59 |
| Etanercept 50 mg Prefilled Syringe | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device | No | 9.00 units on a scale | — |
Comparison: Statistical analysis was carried out between categories, yes and no (reference).p-value: 0.75995% CI: [-5.37, 3.92]Regression, Linear
Secondary
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =\< 11.2, \> 11.2 to 16.2, \> 16.2 to 21.9, \> 21.9.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | =< 11.2 | 8.41 units on a scale | Standard Deviation 2.26 |
| Etanercept 50 mg Auto-injector | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | > 11.2 to 16.2 | 9.17 units on a scale | Standard Deviation 1.97 |
| Etanercept 50 mg Auto-injector | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | > 16.2 to 21.9 | 9.11 units on a scale | Standard Deviation 1.66 |
| Etanercept 50 mg Auto-injector | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | > 21.9 | 9.00 units on a scale | Standard Deviation 1.57 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | > 21.9 | 7.67 units on a scale | Standard Deviation 2.79 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | =< 11.2 | 7.45 units on a scale | Standard Deviation 2.33 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | > 16.2 to 21.9 | 7.67 units on a scale | Standard Deviation 2.49 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | > 11.2 to 16.2 | 7.81 units on a scale | Standard Deviation 2.78 |
Comparison: Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.21195% CI: [-0.01, 0.04]Regression, Linear
Secondary
Influence of Psoriasis Area Severity Index (PASI) on Participant Perception
Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Very satisfied (n=118, 92) | 17.2 units on a scale | Standard Deviation 7.5 |
| Etanercept 50 mg Auto-injector | Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Satisfied (n= 56, 65) | 18.6 units on a scale | Standard Deviation 9.8 |
| Etanercept 50 mg Auto-injector | Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Less satisfied (n= 20, 39) | 17.1 units on a scale | Standard Deviation 8 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Very satisfied (n=118, 92) | 17.9 units on a scale | Standard Deviation 8.5 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Satisfied (n= 56, 65) | 17.5 units on a scale | Standard Deviation 7.9 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Less satisfied (n= 20, 39) | 15.9 units on a scale | Standard Deviation 10.2 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.56ANOVA
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.474ANOVA
Secondary
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =\< 4, \> 4 to 7, \> 7 to 10, \> 10 for HAD-A and =\< 3, \> 3 to 5, \> 5 to 8, \> 8 for HAD-D.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: =< 4 | 8.98 units on a scale | Standard Deviation 1.77 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: > 4 to 7 | 9.17 units on a scale | Standard Deviation 1.48 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: > 7 to 10 | 8.89 units on a scale | Standard Deviation 2.27 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: > 10 | 8.73 units on a scale | Standard Deviation 1.92 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: =< 3 | 8.68 units on a scale | Standard Deviation 2.19 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: > 3 to 5 | 9.15 units on a scale | Standard Deviation 2.04 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: > 5 to 8 | 9.20 units on a scale | Standard Deviation 1.02 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: > 8 | 8.90 units on a scale | Standard Deviation 1.92 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: > 8 | 7.31 units on a scale | Standard Deviation 3.09 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: =< 4 | 7.83 units on a scale | Standard Deviation 2.42 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: =< 3 | 7.93 units on a scale | Standard Deviation 2.39 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: > 4 to 7 | 7.49 units on a scale | Standard Deviation 2.65 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: > 5 to 8 | 7.50 units on a scale | Standard Deviation 2.5 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: > 7 to 10 | 7.42 units on a scale | Standard Deviation 2.88 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-D: > 3 to 5 | 7.57 units on a scale | Standard Deviation 2.42 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | HAD-A: > 10 | 7.74 units on a scale | Standard Deviation 2.44 |
Comparison: Statistical analysis was carried out between categories, HAD-A: =\< 4, HAD-A: \> 4 to 7, HAD-A: \> 7 to 10 and HAD-A: \> 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.49395% CI: [-0.36, 0.17]Regression, Linear
Comparison: Statistical analysis was carried out between categories, HAD-D: =\< 3, HAD-D: \> 3 to 5, HAD-D: \> 5 to 8 and HAD-A: \> 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.28795% CI: [-0.46, 0.14]Regression, Linear
Secondary
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Very satisfied: HAD-A (n=119, 92) | 7.0 units on a scale | Full Range 3.8 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Very satisfied: HAD-D (n=119, 92) | 5.0 units on a scale | Full Range 3.7 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Satisfied: HAD-A (n= 56, 65) | 7.0 units on a scale | Full Range 4.3 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Satisfied: HAD-D (n= 56, 65) | 5.5 units on a scale | Full Range 4 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Less satisfied: HAD-A (n= 20, 41) | 9.2 units on a scale | Full Range 3.5 |
| Etanercept 50 mg Auto-injector | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Less satisfied: HAD-D (n= 20, 41) | 6.5 units on a scale | Full Range 4.2 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Less satisfied: HAD-A (n= 20, 41) | 10.0 units on a scale | Full Range 4.2 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Very satisfied: HAD-A (n=119, 92) | 6.0 units on a scale | Full Range 4.6 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Satisfied: HAD-D (n= 56, 65) | 5.0 units on a scale | Full Range 3.3 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Very satisfied: HAD-D (n=119, 92) | 4.0 units on a scale | Full Range 3.9 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Less satisfied: HAD-D (n= 20, 41) | 8.0 units on a scale | Full Range 4 |
| Etanercept 50 mg Prefilled Syringe | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Satisfied: HAD-A (n= 56, 65) | 7.0 units on a scale | Full Range 4.1 |
Comparison: p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.p-value: 0.029Kruskal-Wallis
Comparison: p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.005Kruskal-Wallis
Comparison: p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.p-value: 0.411Kruskal-Wallis
Comparison: p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.005Kruskal-Wallis
Secondary
Influence of Socio-educational Status on Participant Perception
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Very satisfied: High school level (n=119, 92) | 56 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Satisfied: University level (n= 56, 65) | 10 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Satisfied: Reading/Writing level (n= 56, 65) | 12 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Less satisfied: Reading/Writing level (n= 20, 41) | 10 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Very satisfied: University level (n=119, 92) | 22 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Less satisfied: High school level (n= 20, 41) | 7 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Satisfied: High school level (n= 56, 65) | 34 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Less satisfied: University level (n= 20, 41) | 3 participants |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Perception | Very satisfied: Reading/Writing level (n=119, 92) | 41 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Less satisfied: University level (n= 20, 41) | 9 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Very satisfied: Reading/Writing level (n=119, 92) | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Very satisfied: High school level (n=119, 92) | 43 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Very satisfied: University level (n=119, 92) | 17 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Satisfied: Reading/Writing level (n= 56, 65) | 19 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Satisfied: High school level (n= 56, 65) | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Satisfied: University level (n= 56, 65) | 14 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Less satisfied: Reading/Writing level (n= 20, 41) | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Perception | Less satisfied: High school level (n= 20, 41) | 16 participants |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.158Fisher Exact
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.808Chi-squared
Secondary
Influence of Socio-educational Status on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Satisfaction With Injection Device | Reading /Writing capacity | 9.22 units on a scale | Standard Deviation 1.62 |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Satisfaction With Injection Device | High school /Baccalaureate level | 8.80 units on a scale | Standard Deviation 1.97 |
| Etanercept 50 mg Auto-injector | Influence of Socio-educational Status on Participant Satisfaction With Injection Device | University level | 8.89 units on a scale | Standard Deviation 2.01 |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Satisfaction With Injection Device | Reading /Writing capacity | 7.96 units on a scale | Standard Deviation 2.49 |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Satisfaction With Injection Device | High school /Baccalaureate level | 7.55 units on a scale | Standard Deviation 2.73 |
| Etanercept 50 mg Prefilled Syringe | Influence of Socio-educational Status on Participant Satisfaction With Injection Device | University level | 7.24 units on a scale | Standard Deviation 2.39 |
Comparison: Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).p-value: 0.19595% CI: [-0.89, 0.14]Regression, Linear
Comparison: Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).p-value: 0.19595% CI: [-1.21, 0.11]Regression, Linear
Secondary
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =\< 47.4, \> 47.4 to 56.4, \> 56.4 to 68.5, \> 68.5.
Time frame: Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | =< 47.4 | 8.73 units on a scale | Standard Deviation 1.9 |
| Etanercept 50 mg Auto-injector | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | > 47.4 to 56.4 | 9.41 units on a scale | Standard Deviation 1.14 |
| Etanercept 50 mg Auto-injector | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | > 56.4 to 68.5 | 8.28 units on a scale | Standard Deviation 2.68 |
| Etanercept 50 mg Auto-injector | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | > 68.5 | 9.11 units on a scale | Standard Deviation 1.73 |
| Etanercept 50 mg Prefilled Syringe | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | > 68.5 | 7.93 units on a scale | Standard Deviation 2.49 |
| Etanercept 50 mg Prefilled Syringe | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | =< 47.4 | 7.05 units on a scale | Standard Deviation 2.76 |
| Etanercept 50 mg Prefilled Syringe | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | > 56.4 to 68.5 | 7.94 units on a scale | Standard Deviation 2.7 |
| Etanercept 50 mg Prefilled Syringe | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | > 47.4 to 56.4 | 7.94 units on a scale | Standard Deviation 2.17 |
Comparison: Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.p-value: 0.12395% CI: [-0.04, 0.3]Regression, Linear
Secondary
Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.
Time frame: Baseline
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Very satisfied (n=116, 91) | 58.0 units on a scale | Standard Deviation 13.8 |
| Etanercept 50 mg Auto-injector | Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Satisfied (n= 56, 63) | 53.0 units on a scale | Standard Deviation 11.7 |
| Etanercept 50 mg Auto-injector | Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Less satisfied (n= 20, 40) | 60.0 units on a scale | Standard Deviation 13.9 |
| Etanercept 50 mg Prefilled Syringe | Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Very satisfied (n=116, 91) | 60.5 units on a scale | Standard Deviation 14 |
| Etanercept 50 mg Prefilled Syringe | Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Satisfied (n= 56, 63) | 57.5 units on a scale | Standard Deviation 11.8 |
| Etanercept 50 mg Prefilled Syringe | Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Less satisfied (n= 20, 40) | 52.4 units on a scale | Standard Deviation 12.6 |
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.p-value: 0.039ANOVA
Comparison: p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.p-value: 0.006ANOVA
Secondary
Percentage of Participants Satisfied With Injection Device
Participant satisfaction was assessed by asking the question Are you satisfied with your injection device? and using a dichotomous response: Yes or No.
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Percentage of Participants Satisfied With Injection Device | Baseline- After the training (n=198, 199) | 99.5 percentage of participants |
| Etanercept 50 mg Auto-injector | Percentage of Participants Satisfied With Injection Device | Week 4 (n=190, 190) | 98.9 percentage of participants |
| Etanercept 50 mg Auto-injector | Percentage of Participants Satisfied With Injection Device | Week 12 (n=188, 179) | 98.4 percentage of participants |
| Etanercept 50 mg Auto-injector | Percentage of Participants Satisfied With Injection Device | Last Observation (n=206, 210) | 98.5 percentage of participants |
| Etanercept 50 mg Prefilled Syringe | Percentage of Participants Satisfied With Injection Device | Last Observation (n=206, 210) | 88.6 percentage of participants |
| Etanercept 50 mg Prefilled Syringe | Percentage of Participants Satisfied With Injection Device | Baseline- After the training (n=198, 199) | 92.5 percentage of participants |
| Etanercept 50 mg Prefilled Syringe | Percentage of Participants Satisfied With Injection Device | Week 12 (n=188, 179) | 88.8 percentage of participants |
| Etanercept 50 mg Prefilled Syringe | Percentage of Participants Satisfied With Injection Device | Week 4 (n=190, 190) | 90.0 percentage of participants |
Comparison: Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.p-value: 0.00895% CI: [2.05, 126.9]Generalized estimating equations
Comparison: Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.p-value: 0.00295% CI: [2.44, 51.83]Generalized Estimating Equations
Comparison: Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.p-value: 0.00195% CI: [2.26, 27.44]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used for the analysis.p-value: <0.00195% CI: [2.59, 29.47]Regression, Logistic
Secondary
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg Auto-injector | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Week 12 | 10.1 units on a scale | Standard Deviation 3.2 |
| Etanercept 50 mg Auto-injector | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Week 4 | 9.9 units on a scale | Standard Deviation 3.3 |
| Etanercept 50 mg Auto-injector | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Last observation | 10.1 units on a scale | Standard Deviation 3.3 |
| Etanercept 50 mg Auto-injector | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Baseline- After the training | 11.0 units on a scale | Standard Deviation 3.5 |
| Etanercept 50 mg Prefilled Syringe | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Last observation | 10.1 units on a scale | Standard Deviation 3.3 |
| Etanercept 50 mg Prefilled Syringe | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Week 4 | 10.0 units on a scale | Standard Deviation 3.5 |
| Etanercept 50 mg Prefilled Syringe | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Week 12 | 10.1 units on a scale | Standard Deviation 3.3 |
| Etanercept 50 mg Prefilled Syringe | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | Baseline- After the training | 11.2 units on a scale | Standard Deviation 3.6 |
Comparison: Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.p-value: 0.51595% CI: [-0.91, 0.46]ANOVA
Comparison: Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.p-value: 0.84295% CI: [-0.74, 0.6]ANOVA
Comparison: Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.p-value: 0.92895% CI: [-0.67, 0.61]ANOVA
Comparison: Last observation: ANOVA method was used for the analysis.p-value: 0.97495% CI: [-0.62, 0.64]ANOVA
Secondary
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Side effects related to administration were assessed by participant's response to question, Do you experience pain during or immediately after the injection? scored on a 5-point Likert scale (0= none to 4= severe).
Time frame: Baseline, Week 4 and Week 12
Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 0 | 98 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 1 | 65 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 2 | 24 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 3 | 9 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 4 | 3 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 0 | 77 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 1 | 60 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 2 | 33 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 3 | 22 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 4 | 3 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 0 | 76 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 1 | 68 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 2 | 30 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 3 | 21 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 4 | 4 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 0 | 79 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 1 | 70 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 2 | 31 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 3 | 22 participants |
| Etanercept 50 mg Auto-injector | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 4 | 4 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 2 | 32 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 0 | 109 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 0 | 84 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 1 | 54 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 0 | 90 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 2 | 31 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 1 | 70 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 3 | 8 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 4 | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Baseline- After the first injection: 4 | 0 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 2 | 28 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 0 | 88 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 1 | 72 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 1 | 60 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 3 | 15 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 2 | 31 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Last observation: 3 | 16 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 3 | 21 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 12: 4 | 1 participants |
| Etanercept 50 mg Prefilled Syringe | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Week 4: 4 | 1 participants |
Comparison: Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.4795% CI: [0.6, 1.26]Generalized estimating equations
Comparison: Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.32595% CI: [0.57, 1.2]Generalized Estimating Equations
Comparison: Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.p-value: 0.19795% CI: [0.55, 1.13]Generalized Estimating Equations
Comparison: Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.p-value: 0.21295% CI: [0.56, 1.14]Regression, Logistic