Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

A 3-Month, Randomised, Open-Label, Parallel-Group, Descriptive Study To Explore And Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00459706

Enrollment

640

Registered

2007-04-12

Start date

2007-09-30

Completion date

2009-09-30

Last updated

2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Brief summary

The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

Detailed description

This study describes 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, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews. 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, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).

Interventions

DEVICEEnbrel 50 mg Prefilled Syringe

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Prefilled Syringe

DEVICEEnbrel 50 mg Autoinjector

Enbrel 50 mg subcutaneously once weekly for 12 Weeks using Autoinjector

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion: * Diagnosis of RA according to the ACR-Criteria. * Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines. * Willing and able to self-inject etanercept. Exclusion: * Prior experience of biologics and anti-TNF treatment for their RA including etanercept. * Sepsis or risk of sepsis. * Current or recent infections, including chronic or localized.

Design outcomes

Primary

Measure	Time frame	Description
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population	Day 84	Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population	Day 84	Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.

Secondary

Measure	Time frame	Description
Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Results are reported by age categories: \<=46 years, \>46-55 years, \>55-65 years, \>65 years.
Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism.
Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Participants were categorized into those having only reading/writing capacity, those at the high-school/baccalaureate level, and those at the university level.
Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, odd-numbered questions related to anxiety. Responses scored on a 4-point scale; each question was graded in a different way. Anxiety subscale scores ranged from 0 to 21. Lower HAD Anxiety subscale scores indicated better health. Categories are anxiety subscale scores.
Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, even-numbered questions related to depression. Responses scored on a 4-point scale; each question was graded in a different way. Depression subscale scores ranged from 0 to 21. Lower HAD Depression subscale scores indicated better health. Categories are depression subscale scores.
Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. 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. Results reported by PAM score: \<=49.9, \>49.9-56.4, \>56.4-66, \>66.
Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior self-injection experience. Higher scores indicated greater satisfaction in the delivery mechanism.
Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Results are reported by duration of RA: \<=3 years, \>3-6 years, \>6-13 years, \>13 years.
Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2\<score≤5.1, or high when score \>5.1, remission when score \<2.6. Results are reported by categories of DAS28 score: \<=4.7, \>4.7-5.4, \>5.4-6.2, \>6.2.
Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants' global assessment of disease activity was measured on a visual analog scale (VAS) ranging from 0 (inactive) to 100 millimeter (mm) (extremely active). Results are reported by VAS scores observed for the participant's global assessment of RA activity: \<=50 mm, \>50-67 mm, \>67-79 mm, \>79 mm.
Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Physicians' global assessment of disease activity was measured on a VAS ranging from 0 (inactive) to 100 mm (extremely active). Results are reported by VAS scores observed for physician's global assessment of RA activity: \<=47 mm, \>47-61 mm, \>61-72 mm, \>72 mm.
Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The 20-item HAQ-DI assessed the extent of participants' functional ability. Calculation yielded a single disability score from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health. Results are reported by categories of HAQ-DI scores observed: \<=0.9, \>0.9-1.4, \>1.4-1.9, \>1.9.
Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants were categorized into those who received only 1 DMARD, only 2 DMARDs, only 3 DMARDs, and at least 3 DMARDs.
Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept	Day 84	Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior injection experience. Higher scores indicated greater satisfaction with the delivery mechanism.
Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score	Day 84	The SF-STAI consisted of 6 questions, each scored from 1 to 4. Total score ranged from 6=less anxiety to 24=more anxiety. Higher score indicated that the participant was more anxious.
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?	Day 84	Score indicated satisfaction in response to the question Thinking about your own life and personal circumstances, how satisfied are you with your life as a whole? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction.
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?	Day 84	Score indicated satisfaction in response to the question How satisfied are you with your health? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction.
Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?	Day 84	Score indicated satisfaction in response to the question How satisfied are you with all the treatments you are currently receiving for your rheumatoid arthritis? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q1: Overall, How Easy Was It to Perform an Injection with this Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q2: How Easy Was It to Learn to Use the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q3: How Easy Is It to Dispose Of the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q4: How Easy Is It to Know When the Injection Is Completed? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q5: How Easy Is It to Hold the Device Whilst Injecting? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q6: Did You Feel any Hand Discomfort Whilst Using the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q7: How Long Does It Take to Perform the Injection, Including any Preparation and Disposal? Participants specified their responses on a 5-point Likert scale: 0=\<5 minutes to 4=\>30 minutes.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q8: How Much Do You Think Injecting Etanercept Will Interfere with Your Ability to Enjoy Social or Leisure Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q9: Do You Think Injecting Etanercept Will Interfere with Your Usual Daily Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q10: How Much Do You Think Injecting Etanercept Will Interfere with Travelling on Holiday/ Business/Visiting? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q11: Overall, How Confident Are You in Your Management of Your Weekly Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q12: How Confident Are You That You Inject the Right Amount of Medicine Every Time? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q13: How Confident Are You That You Can Inject Yourself Properly with the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q14: Are You Confident That You Have Good Control over the Injection Process? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q15: How Confident Are You That You Injected Yourself Successfully? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q16: Overall, How Nervous Do You Feel about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q17: Overall, How Nervous Do You Feel about Inserting the Needle into Your Skin? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q18: Do You Dislike Injecting Yourself with this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q19: Overall, Are You Emotionally Distressed or Anxious about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q20: How Much Do You Like the Look of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q21: How Much Do You Like the Feel of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q22: How Much Does the Device Look Like Something You Would Feel Comfortable to Use? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: Side Effects from Using the Device - Q23: Do You Experience Pain During or Immediately After the Injection? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q24: To What Extent Would You Consider Alternative Devices If You Were to Continue on Etanercept? Participants specified their responses on a 5-point Likert scale: 0=very little to 4=very much.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q25: Would You Recommend this Device to Someone Else Who Needed to Self Inject? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=yes definitely.
Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	Day 84	Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q26: If Your Doctor Advised You to, How Likely Would You to Be Continue Injecting Regularly With this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very likely.
Age Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean age was determined for each cluster of participants.
Percentage of Male Participants Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants who were male was determined for each cluster of participants.
Percentage of Female Participants Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants who were female was determined for each cluster of participants.
Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants with only reading/writing capacity was determined for each cluster of participants.
Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at high school/baccalaureate level was determined for each cluster of participants.
Percentage of Participants at University Level Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at the university level was determined for each cluster of participants.
HAD Anxiety Subscale Score Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Anxiety Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.
HAD Depression Subscale Score Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Depression Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.
PAM Score Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean PAM Score was determined for each cluster of participants. Calibrated PAM scale score ranged from 0 to 100.Higher scores indicated more confidence in managing participants' condition and lifestyle.
Percentage of Participants With Prior Injection Experience Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants with prior injection experience was determined for each cluster of participants.
Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The percentage of participants with prior self-injection experience was determined for each cluster of participants.
RA Duration Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean RA Duration was determined for each cluster of participants.
DAS28 Score Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean DAS28 Score was determined for each cluster of participants. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2\<score≤5.1, or high when score \>5.1, remission when score \<2.6.
Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept	Day 28	Percentage of participants answering Yes to the question Are you satisfied with your injection device?
Physician's Global Assessment of RA Activity Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean Physician's Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).
HAQ-DI Score Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAQ-DI Score, assessing the extent of functional ability, was determined for each cluster of participants. Disability score ranged from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health.
Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 1 DMARD was determined for each cluster of participants.
Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 2 DMARDs was determined for each cluster of participants.
Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 3 DMARDs was determined for each cluster of participants.
Participant Satisfaction at Endpoint Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean participant satisfaction was determined for each cluster of participants. Satisfaction was scored on a 10-point scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction.
Participant's Global Assessment of RA Activity Associated With Participant Perception	Day 84	Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participants' mean Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).
Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept	Day 84	Percentage of participants answering Yes to the question Are you satisfied with your injection device?

Countries

Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Sweden, United Kingdom

Participant flow

Participants by arm

Arm	Count
Enbrel 50 mg Autoinjector Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector	325
Enbrel 50 mg Prefilled Syringe Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe	315
Total	640

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	19	13
Overall Study	Discontinuation of Study by Sponsor	1	0
Overall Study	Failed to Return	1	0
Overall Study	Other	0	1
Overall Study	Physician Decision	2	0
Overall Study	Protocol Violation	2	1
Overall Study	Withdrawal by Subject	1	6

Baseline characteristics

Characteristic	Enbrel 50 mg Autoinjector	Enbrel 50 mg Prefilled Syringe	Total
Age Continuous	54.7 years STANDARD_DEVIATION 12.9	54.8 years STANDARD_DEVIATION 12.9	54.7 years STANDARD_DEVIATION 12.9
Sex/Gender, Customized Female	240 participants	237 participants	477 participants
Sex/Gender, Customized Male	85 participants	78 participants	163 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	203 / 325	201 / 313
serious Total, serious adverse events	18 / 325	9 / 313

Outcome results

Primary

Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population

Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.

Time frame: Day 84

Population: Modified Intent-to-Treat (mITT): All randomized participants who received at least 1 injection of test article and had at least 1 available evaluation after the first administration of test article. Number of participants analyzed (N) = participants with evaluable data.

Arm	Measure	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population	8.3 units on a scale	Standard Deviation 2.4
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population	7.2 units on a scale	Standard Deviation 2.6

Comparison: Non-inferiority of autoinjector (AI) over prefilled syringe (PFS) was assessed on the primary endpoint. Hypothesis tested was H0: AI minus PFS less than or equal to (≤) -1. The alternate hypothesis was H1: AI minus PFS greater than (\>) -1.p-value: <0.00195% CI: [0.71, 1.5]ANOVA

Primary

Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population

Time frame: Day 84

Population: Per-protocol (PP): mITT participants who completed the study with no major protocol violation. N=participants with evaluable data.

Arm	Measure	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population	8.4 units on a scale	Standard Deviation 2.2
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population	7.2 units on a scale	Standard Deviation 2.6

Comparison: Non-inferiority of AI over PFS was assessed on the primary endpoint. The hypotheses tested was as follows:~H0: AI - PFS ≤ -1 H1: AI - PFS \> -1p-value: <0.00195% CI: [0.85, 1.64]ANOVA

Secondary

Age Associated With Participant Perception

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 age clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Age Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	54.3 years	Standard Deviation 12.3
Enbrel 50 mg Autoinjector	Age Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	55.1 years	Standard Deviation 11.9
Enbrel 50 mg Autoinjector	Age Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	54.0 years	Standard Deviation 14.6
Enbrel 50 mg Prefilled Syringe	Age Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	56.0 years	Standard Deviation 13
Enbrel 50 mg Prefilled Syringe	Age Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	54.1 years	Standard Deviation 12.5
Enbrel 50 mg Prefilled Syringe	Age Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	52.7 years	Standard Deviation 13.2

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.896ANOVA

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.166ANOVA

Secondary

DAS28 Score Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean DAS28 Score was determined for each cluster of participants. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2\<score≤5.1, or high when score \>5.1, remission when score \<2.6.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	DAS28 Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=197, 128)	5.3 units on a scale	Standard Deviation 1.1
Enbrel 50 mg Autoinjector	DAS28 Score Associated With Participant Perception	Cluster 2, Satisfied (n=50, 70)	5.4 units on a scale	Standard Deviation 1.3
Enbrel 50 mg Autoinjector	DAS28 Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=45, 89)	5.5 units on a scale	Standard Deviation 1.1
Enbrel 50 mg Prefilled Syringe	DAS28 Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=197, 128)	5.5 units on a scale	Standard Deviation 1.1
Enbrel 50 mg Prefilled Syringe	DAS28 Score Associated With Participant Perception	Cluster 2, Satisfied (n=50, 70)	5.0 units on a scale	Standard Deviation 1.3
Enbrel 50 mg Prefilled Syringe	DAS28 Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=45, 89)	5.5 units on a scale	Standard Deviation 1.2

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.466Kruskal-Wallis

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.035Kruskal-Wallis

Secondary

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?

Score indicated satisfaction in response to the question How satisfied are you with all the treatments you are currently receiving for your rheumatoid arthritis? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction.

Time frame: Day 84

Population: mITT. N=number of evaluable participants.

Arm	Measure	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?	7.4 units on a scale	Standard Deviation 2.4
Enbrel 50 mg Prefilled Syringe	Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?	7.3 units on a scale	Standard Deviation 2.4

p-value: 0.51995% CI: [-0.25, 0.5]ANOVA

Secondary

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?

Score indicated satisfaction in response to the question How satisfied are you with your health? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction.

Time frame: Day 84

Population: mITT. N=number of evaluable participants.

Arm	Measure	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?	6.1 units on a scale	Standard Deviation 2.5
Enbrel 50 mg Prefilled Syringe	Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?	6.1 units on a scale	Standard Deviation 2.4

p-value: 0.96595% CI: [-0.39, 0.37]ANOVA

Secondary

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?

Score indicated satisfaction in response to the question Thinking about your own life and personal circumstances, how satisfied are you with your life as a whole? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction.

Time frame: Day 84

Population: mITT. N=number of evaluable participants.

Arm	Measure	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?	7.3 units on a scale	Standard Deviation 2.2
Enbrel 50 mg Prefilled Syringe	Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?	7.1 units on a scale	Standard Deviation 2.1

p-value: 0.21295% CI: [-0.12, 0.56]ANOVA

Secondary

HAD Anxiety Subscale Score Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Anxiety Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.

Time frame: Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	HAD Anxiety Subscale Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	6.8 units on a scale	Standard Deviation 4.2
Enbrel 50 mg Autoinjector	HAD Anxiety Subscale Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	7.9 units on a scale	Standard Deviation 3.8
Enbrel 50 mg Autoinjector	HAD Anxiety Subscale Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	8.3 units on a scale	Standard Deviation 3.7
Enbrel 50 mg Prefilled Syringe	HAD Anxiety Subscale Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	6.4 units on a scale	Standard Deviation 4.5
Enbrel 50 mg Prefilled Syringe	HAD Anxiety Subscale Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	7.4 units on a scale	Standard Deviation 4
Enbrel 50 mg Prefilled Syringe	HAD Anxiety Subscale Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	8.7 units on a scale	Standard Deviation 3.8

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.023Kruskal-Wallis

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: <0.001Kruskal-Wallis

Secondary

HAD Depression Subscale Score Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Depression Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.

Time frame: Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	HAD Depression Subscale Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 133)	5.8 units on a scale	Standard Deviation 3.8
Enbrel 50 mg Autoinjector	HAD Depression Subscale Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	6.6 units on a scale	Standard Deviation 3.9
Enbrel 50 mg Autoinjector	HAD Depression Subscale Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	7.3 units on a scale	Standard Deviation 4.1
Enbrel 50 mg Prefilled Syringe	HAD Depression Subscale Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	6.7 units on a scale	Standard Deviation 3.6
Enbrel 50 mg Prefilled Syringe	HAD Depression Subscale Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 133)	5.0 units on a scale	Standard Deviation 3.9
Enbrel 50 mg Prefilled Syringe	HAD Depression Subscale Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	5.2 units on a scale	Standard Deviation 3.5

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.038Kruskal-Wallis

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: <0.001Kruskal-Wallis

Secondary

HAQ-DI Score Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAQ-DI Score, assessing the extent of functional ability, was determined for each cluster of participants. Disability score ranged from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health.

Time frame: Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	HAQ-DI Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	1.4 units on a scale	Standard Deviation 0.7
Enbrel 50 mg Autoinjector	HAQ-DI Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	1.5 units on a scale	Standard Deviation 0.6
Enbrel 50 mg Autoinjector	HAQ-DI Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=45, 92)	1.5 units on a scale	Standard Deviation 0.6
Enbrel 50 mg Prefilled Syringe	HAQ-DI Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	1.3 units on a scale	Standard Deviation 0.7
Enbrel 50 mg Prefilled Syringe	HAQ-DI Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	1.3 units on a scale	Standard Deviation 0.6
Enbrel 50 mg Prefilled Syringe	HAQ-DI Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=45, 92)	1.6 units on a scale	Standard Deviation 0.6

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.15Kruskal-Wallis

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.002Kruskal-Wallis

Secondary

PAM Score Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean PAM Score was determined for each cluster of participants. Calibrated PAM scale score ranged from 0 to 100.Higher scores indicated more confidence in managing participants' condition and lifestyle.

Time frame: Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	PAM Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=198, 131)	61.6 units on a scale	Standard Deviation 13.1
Enbrel 50 mg Autoinjector	PAM Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	56.6 units on a scale	Standard Deviation 11.5
Enbrel 50 mg Autoinjector	PAM Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 91)	57.4 units on a scale	Standard Deviation 13.8
Enbrel 50 mg Prefilled Syringe	PAM Score Associated With Participant Perception	Cluster 1, Very Satisfied (n=198, 131)	60.1 units on a scale	Standard Deviation 14
Enbrel 50 mg Prefilled Syringe	PAM Score Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	56.5 units on a scale	Standard Deviation 11.7
Enbrel 50 mg Prefilled Syringe	PAM Score Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 91)	55.3 units on a scale	Standard Deviation 11.9

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.018ANOVA

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.019ANOVA

Secondary

Participant Satisfaction at Endpoint Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean participant satisfaction was determined for each cluster of participants. Satisfaction was scored on a 10-point scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction.

Time frame: Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction at Endpoint Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	9.0 units on a scale	Standard Deviation 1.9
Enbrel 50 mg Autoinjector	Participant Satisfaction at Endpoint Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	8.1 units on a scale	Standard Deviation 1.7
Enbrel 50 mg Autoinjector	Participant Satisfaction at Endpoint Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	5.5 units on a scale	Standard Deviation 2.8
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction at Endpoint Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	8.0 units on a scale	Standard Deviation 2.5
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction at Endpoint Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	8.2 units on a scale	Standard Deviation 1.6
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction at Endpoint Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	5.3 units on a scale	Standard Deviation 2.4

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: <0.001Kruskal-Wallis

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: <0.001Kruskal-Wallis

Secondary

Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2\<score≤5.1, or high when score \>5.1, remission when score \<2.6. Results are reported by categories of DAS28 score: \<=4.7, \>4.7-5.4, \>5.4-6.2, \>6.2.

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score <=4.7	8.24 units on a scale	Standard Deviation 2.5
Enbrel 50 mg Autoinjector	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score >4.7 - 5.4	8.11 units on a scale	Standard Deviation 2.59
Enbrel 50 mg Autoinjector	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score >5.4 - 6.2	8.45 units on a scale	Standard Deviation 2.19
Enbrel 50 mg Autoinjector	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score >6.2	8.31 units on a scale	Standard Deviation 2.23
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score >6.2	6.90 units on a scale	Standard Deviation 2.85
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score <=4.7	7.01 units on a scale	Standard Deviation 2.5
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score >5.4 - 6.2	7.58 units on a scale	Standard Deviation 2.55
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept	DAS28 score >4.7 - 5.4	7.36 units on a scale	Standard Deviation 2.64

Comparison: All categoriesp-value: 0.74995% CI: [-0.15, 0.21]Regression, Linear

Secondary

Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept

Time frame: Day 84

Population: mITT; last observation carried forward (LOCF).

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	<=46 years	8.18 units on a scale	Standard Deviation 2.52
Enbrel 50 mg Autoinjector	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	>55 - 65 years	8.31 units on a scale	Standard Deviation 2.44
Enbrel 50 mg Autoinjector	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	>65 years	7.74 units on a scale	Standard Deviation 2.54
Enbrel 50 mg Autoinjector	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	>46 - 55 years	8.81 units on a scale	Standard Deviation 1.84
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	>65 years	7.63 units on a scale	Standard Deviation 2.28
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	<=46 years	6.58 units on a scale	Standard Deviation 2.73
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	>46 - 55 years	7.01 units on a scale	Standard Deviation 2.7
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept	>55 - 65 years	7.56 units on a scale	Standard Deviation 2.57

Comparison: All categoriesp-value: 0.1695% CI: [-0.04, 0.27]Regression, Linear

Secondary

Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration <=3 years	7.99 units on a scale	Standard Deviation 2.56
Enbrel 50 mg Autoinjector	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration >3 - 6 years	8.39 units on a scale	Standard Deviation 2.34
Enbrel 50 mg Autoinjector	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration >6 - 13 years	8.52 units on a scale	Standard Deviation 2.37
Enbrel 50 mg Autoinjector	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration >13 years	8.29 units on a scale	Standard Deviation 2.14
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration >13 years	7.40 units on a scale	Standard Deviation 2.47
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration <=3 years	7.32 units on a scale	Standard Deviation 2.59
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration >6 - 13 years	7.24 units on a scale	Standard Deviation 2.67
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept	RA duration >3 - 6 years	6.68 units on a scale	Standard Deviation 2.83

Comparison: All categoriesp-value: 0.27895% CI: [-0.05, 0.18]Regression, Linear

Secondary

Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism.

Time frame: Day 84

Population: mITT; LOCF. N=total evaluable participants. n=participants evaluable in that category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept	Male (n=85, 77)	8.45 units on a scale	Standard Deviation 2.31
Enbrel 50 mg Autoinjector	Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept	Female (n=239, 236)	8.21 units on a scale	Standard Deviation 2.4
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept	Male (n=85, 77)	8.13 units on a scale	Standard Deviation 2.07
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept	Female (n=239, 236)	6.89 units on a scale	Standard Deviation 2.72

Comparison: Female versus male (reference).p-value: 0.00195% CI: [-1.2, -0.29]Regression, Linear

Secondary

Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The 20-item HAQ-DI assessed the extent of participants' functional ability. Calculation yielded a single disability score from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health. Results are reported by categories of HAQ-DI scores observed: \<=0.9, \>0.9-1.4, \>1.4-1.9, \>1.9.

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score <=0.9	8.61 units on a scale	Standard Deviation 2.07
Enbrel 50 mg Autoinjector	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score >0.9 - 1.4	8.27 units on a scale	Standard Deviation 2.37
Enbrel 50 mg Autoinjector	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score >1.4 - 1.9	8.33 units on a scale	Standard Deviation 2.37
Enbrel 50 mg Autoinjector	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score >1.9	7.96 units on a scale	Standard Deviation 2.58
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score >1.9	6.57 units on a scale	Standard Deviation 2.95
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score <=0.9	7.67 units on a scale	Standard Deviation 2.24
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score >1.4 - 1.9	7.03 units on a scale	Standard Deviation 2.84
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept	HAQ-DI scale score >0.9 - 1.4	7.40 units on a scale	Standard Deviation 2.39

Comparison: All categories, by 1-unit increments.p-value: 0.01295% CI: [-0.69, -0.09]Regression, Linear

Secondary

Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept

Time frame: Day 84

Population: mITT; LOCF. N=total evaluable participants. n=total evaluable participants for that category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	1 DMARD (n=177, 162)	8.29 units on a scale	Standard Deviation 2.41
Enbrel 50 mg Autoinjector	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	2 DMARDs (n=123, 123)	8.18 units on a scale	Standard Deviation 2.42
Enbrel 50 mg Autoinjector	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	3 DMARDs (n=16, 26)	8.94 units on a scale	Standard Deviation 1.84
Enbrel 50 mg Autoinjector	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	At Least 4 DMARDs (n=4, 0)	9.50 units on a scale	Standard Deviation 1
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	At Least 4 DMARDs (n=4, 0)	NA units on a scale	—
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	1 DMARD (n=177, 162)	7.23 units on a scale	Standard Deviation 2.66
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	3 DMARDs (n=16, 26)	6.85 units on a scale	Standard Deviation 3.04
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept	2 DMARDs (n=123, 123)	7.19 units on a scale	Standard Deviation 2.53

Comparison: 2 DMARDs versus 1 DMARD (reference).p-value: 0.54195% CI: [-0.52, 0.32]Regression, Linear

Comparison: 3 DMARDs versus 1 DMARD (reference).p-value: 0.54195% CI: [-0.97, 0.68]Regression, Linear

Comparison: At least 4 DMARDs versus 1 DMARD (reference).p-value: 0.54195% CI: [-0.82, 4.25]Regression, Linear

Secondary

Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants' global assessment of disease activity was measured on a visual analog scale (VAS) ranging from 0 (inactive) to 100 millimeter (mm) (extremely active). Results are reported by VAS scores observed for the participant's global assessment of RA activity: \<=50 mm, \>50-67 mm, \>67-79 mm, \>79 mm.

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment <=50 mm	8.45 units on a scale	Standard Deviation 2.14
Enbrel 50 mg Autoinjector	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment >50 - 67	8.41 units on a scale	Standard Deviation 2.15
Enbrel 50 mg Autoinjector	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment >67 - 79 mm	8.07 units on a scale	Standard Deviation 2.6
Enbrel 50 mg Autoinjector	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment >79 mm	8.17 units on a scale	Standard Deviation 2.59
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment >79 mm	6.88 units on a scale	Standard Deviation 2.83
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment <=50 mm	7.55 units on a scale	Standard Deviation 2.43
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment >67 - 79 mm	7.11 units on a scale	Standard Deviation 2.53
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for participant's assessment >50 - 67	7.31 units on a scale	Standard Deviation 2.61

Comparison: All categoriesp-value: 0.10595% CI: [-0.18, 0.02]Regression, Linear

Secondary

Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. 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. Results reported by PAM score: \<=49.9, \>49.9-56.4, \>56.4-66, \>66.

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score <=49.9	7.91 units on a scale	Standard Deviation 2.58
Enbrel 50 mg Autoinjector	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score >49.9 - 56.4	8.48 units on a scale	Standard Deviation 2.14
Enbrel 50 mg Autoinjector	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score >56.4 - 66	8.02 units on a scale	Standard Deviation 2.56
Enbrel 50 mg Autoinjector	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score >66	8.49 units on a scale	Standard Deviation 2.32
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score >66	7.38 units on a scale	Standard Deviation 2.63
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score <=49.9	7.06 units on a scale	Standard Deviation 2.72
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score >56.4 - 66	6.97 units on a scale	Standard Deviation 2.83
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept	PAM scale score >49.9 - 56.4	7.42 units on a scale	Standard Deviation 2.36

Comparison: All categoriesp-value: 0.0395% CI: [0.02, 0.32]Regression, Linear

Secondary

Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Physicians' global assessment of disease activity was measured on a VAS ranging from 0 (inactive) to 100 mm (extremely active). Results are reported by VAS scores observed for physician's global assessment of RA activity: \<=47 mm, \>47-61 mm, \>61-72 mm, \>72 mm.

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment <=47 mm	8.23 units on a scale	Standard Deviation 2.4
Enbrel 50 mg Autoinjector	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment >47 - 61 mm	8.36 units on a scale	Standard Deviation 2
Enbrel 50 mg Autoinjector	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment >61 - 72 mm	8.03 units on a scale	Standard Deviation 2.75
Enbrel 50 mg Autoinjector	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment >72 mm	8.47 units on a scale	Standard Deviation 2.34
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment >72 mm	7.32 units on a scale	Standard Deviation 2.59
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment <=47 mm	7.40 units on a scale	Standard Deviation 2.24
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment >61 - 72 mm	7.14 units on a scale	Standard Deviation 2.96
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept	VAS score for physician's assessment >47 - 61 mm	6.92 units on a scale	Standard Deviation 2.73

Comparison: All categoriesp-value: 0.81995% CI: [-0.1, 0.12]Regression, Linear

Secondary

Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior injection experience. Higher scores indicated greater satisfaction with the delivery mechanism.

Time frame: Day 84

Population: mITT; LOCF. n=evaluable participants in that category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept	Prior Injection Experience (n=177, 174)	8.29 units on a scale	Standard Deviation 2.35
Enbrel 50 mg Autoinjector	Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept	No Prior Injection Experience (n=147, 139)	8.24 units on a scale	Standard Deviation 2.42
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept	Prior Injection Experience (n=177, 174)	7.05 units on a scale	Standard Deviation 2.53
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept	No Prior Injection Experience (n=147, 139)	7.37 units on a scale	Standard Deviation 2.75

Comparison: Prior Injection Experience versus No Prior Injection Experience (reference)p-value: 0.46595% CI: [-0.55, 0.25]Regression, Linear

Secondary

Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior self-injection experience. Higher scores indicated greater satisfaction in the delivery mechanism.

Time frame: Day 84

Population: mITT; LOCF. N=total evaluable participants. n=evaluable participants for that category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept	Self-Injection Experience (n=97, 101)	8.10 units on a scale	Standard Deviation 2.51
Enbrel 50 mg Autoinjector	Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept	No Self-Injection Experience (n=227, 212)	8.34 units on a scale	Standard Deviation 2.32
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept	Self-Injection Experience (n=97, 101)	6.57 units on a scale	Standard Deviation 2.51
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept	No Self-Injection Experience (n=227, 212)	7.49 units on a scale	Standard Deviation 2.64

Comparison: Self-injection Experience versus No Self-injection Experience (reference).p-value: 0.00695% CI: [-1.03, -0.18]Regression, Linear

Secondary

Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Participants were categorized into those having only reading/writing capacity, those at the high-school/baccalaureate level, and those at the university level.

Time frame: Day 84

Population: mITT; LOCF. N=total participants with evaluable data. n=participants with evaluable data for that category.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept	Only Reading/Writing Capacity (n=122, 129)	8.11 units on a scale	Standard Deviation 2.24
Enbrel 50 mg Autoinjector	Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept	High School/Baccalaureate Level (n=147, 136)	8.32 units on a scale	Standard Deviation 2.5
Enbrel 50 mg Autoinjector	Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept	University Level (n=54, 46)	8.44 units on a scale	Standard Deviation 2.36
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept	Only Reading/Writing Capacity (n=122, 129)	7.53 units on a scale	Standard Deviation 2.44
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept	High School/Baccalaureate Level (n=147, 136)	6.90 units on a scale	Standard Deviation 2.87
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept	University Level (n=54, 46)	7.09 units on a scale	Standard Deviation 2.38

Comparison: Participants at High School/Baccalaureate Level versus participants with only Reading/Writing Capacity (reference).p-value: 0.67695% CI: [-0.62, 0.26]Regression, Linear

Comparison: Participants at University Level versus participants with only Reading/Writing Capacity (reference).p-value: 0.67695% CI: [-0.59, 0.6]Regression, Linear

Secondary

Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, even-numbered questions related to depression. Responses scored on a 4-point scale; each question was graded in a different way. Depression subscale scores ranged from 0 to 21. Lower HAD Depression subscale scores indicated better health. Categories are depression subscale scores.

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score <=3	8.75 units on a scale	Standard Deviation 2.02
Enbrel 50 mg Autoinjector	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score >3 - 5	7.97 units on a scale	Standard Deviation 2.58
Enbrel 50 mg Autoinjector	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score >5 - 8.2	8.28 units on a scale	Standard Deviation 2.39
Enbrel 50 mg Autoinjector	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score >8.2	8.03 units on a scale	Standard Deviation 2.48
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score >8.2	6.23 units on a scale	Standard Deviation 2.94
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score <=3	7.70 units on a scale	Standard Deviation 2.37
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score >5 - 8.2	7.17 units on a scale	Standard Deviation 2.49
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD depression subscale score >3 - 5	7.35 units on a scale	Standard Deviation 2.66

Comparison: All categoriesp-value: 0.00895% CI: [-0.61, -0.09]Regression, Linear

Secondary

Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept

Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, odd-numbered questions related to anxiety. Responses scored on a 4-point scale; each question was graded in a different way. Anxiety subscale scores ranged from 0 to 21. Lower HAD Anxiety subscale scores indicated better health. Categories are anxiety subscale scores.

Time frame: Day 84

Population: mITT; LOCF.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score <=4	8.56 units on a scale	Standard Deviation 2.29
Enbrel 50 mg Autoinjector	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score >4 - 7	8.13 units on a scale	Standard Deviation 2.47
Enbrel 50 mg Autoinjector	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score >7 - 10	7.87 units on a scale	Standard Deviation 2.68
Enbrel 50 mg Autoinjector	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score >10	8.46 units on a scale	Standard Deviation 2.06
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score >10	6.67 units on a scale	Standard Deviation 2.97
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score <=4	7.67 units on a scale	Standard Deviation 2.44
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score >7 - 10	6.93 units on a scale	Standard Deviation 2.53
Enbrel 50 mg Prefilled Syringe	Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept	HAD anxiety subscale score >4 - 7	7.32 units on a scale	Standard Deviation 2.56

Comparison: All categoriesp-value: 0.0295% CI: [-0.52, -0.05]Regression, Linear

Secondary

Participant's Global Assessment of RA Activity Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participants' mean Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).

Time frame: Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Participant's Global Assessment of RA Activity Associated With Participant Perception	Cluster 1, Very Satisfied (n=202, 132)	63.5 millimeters on the VAS	Standard Deviation 20.2
Enbrel 50 mg Autoinjector	Participant's Global Assessment of RA Activity Associated With Participant Perception	Cluster 2, Satisfied (n=50, 71)	64.7 millimeters on the VAS	Standard Deviation 19.2
Enbrel 50 mg Autoinjector	Participant's Global Assessment of RA Activity Associated With Participant Perception	Cluster 3, Not Satisfied (n=46, 91)	65.7 millimeters on the VAS	Standard Deviation 19.5
Enbrel 50 mg Prefilled Syringe	Participant's Global Assessment of RA Activity Associated With Participant Perception	Cluster 1, Very Satisfied (n=202, 132)	62.5 millimeters on the VAS	Standard Deviation 21.4
Enbrel 50 mg Prefilled Syringe	Participant's Global Assessment of RA Activity Associated With Participant Perception	Cluster 2, Satisfied (n=50, 71)	57.5 millimeters on the VAS	Standard Deviation 24
Enbrel 50 mg Prefilled Syringe	Participant's Global Assessment of RA Activity Associated With Participant Perception	Cluster 3, Not Satisfied (n=46, 91)	68.2 millimeters on the VAS	Standard Deviation 17.6

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.784ANOVA

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.006ANOVA

Secondary

Percentage of Female Participants Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants who were female was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants (male+female) across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants (male+female) who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and gender.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Female Participants Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	69.1 percentage of female participants
Enbrel 50 mg Autoinjector	Percentage of Female Participants Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	76.5 percentage of female participants
Enbrel 50 mg Autoinjector	Percentage of Female Participants Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	85.1 percentage of female participants
Enbrel 50 mg Prefilled Syringe	Percentage of Female Participants Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	69.9 percentage of female participants
Enbrel 50 mg Prefilled Syringe	Percentage of Female Participants Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	70.4 percentage of female participants
Enbrel 50 mg Prefilled Syringe	Percentage of Female Participants Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	85.9 percentage of female participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.069Chi-squared

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.015Chi-squared

Secondary

Percentage of Male Participants Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants who were male was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. n=number of participants (male plus female) who reported themselves as being very satisfied, satisfied, or not for the specified treatment arm.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Male Participants Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	30.9 percentage of male participants
Enbrel 50 mg Autoinjector	Percentage of Male Participants Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	23.5 percentage of male participants
Enbrel 50 mg Autoinjector	Percentage of Male Participants Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	14.9 percentage of male participants
Enbrel 50 mg Prefilled Syringe	Percentage of Male Participants Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	30.1 percentage of male participants
Enbrel 50 mg Prefilled Syringe	Percentage of Male Participants Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	29.6 percentage of male participants
Enbrel 50 mg Prefilled Syringe	Percentage of Male Participants Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	14.1 percentage of male participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.069Chi-squared

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.015Chi-squared

Secondary

Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at high school/baccalaureate level was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants at all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	48.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception	Cluster 2, Satisfied (n=51, 70)	37.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	48.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	43.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception	Cluster 2, Satisfied (n=51, 70)	41.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	47.8 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.652Chi-squared

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.459Chi-squared

Secondary

Percentage of Participants at University Level Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at the university level was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants at University Level Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	16.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants at University Level Associated With Participant Perception	Cluster 2, Satisfied (n=51, 70)	17.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants at University Level Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	14.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants at University Level Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	12.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants at University Level Associated With Participant Perception	Cluster 2, Satisfied (n=51, 70)	15.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants at University Level Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	18.5 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.652Chi-squared

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.459Chi-squared

Secondary

Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept

Percentage of participants answering Yes to the question Are you satisfied with your injection device?

Time frame: Day 28

Population: mITT. N=participants with evaluable data.

Arm	Measure	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept	92.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept	88.6 percentage of participants

p-value: 0.05895% CI: [0.98, 3.05]GEE Model+Logit Link+Binomial Distributn

Secondary

Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept

Percentage of participants answering Yes to the question Are you satisfied with your injection device?

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept	93.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept	87.7 percentage of participants

p-value: 0.01995% CI: [1.12, 3.43]GEE Model+Logit Link+Binomial Distributn

Secondary

Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 1 DMARD was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 1 DMARD who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception	Cluster 1, Very Satisfied (n=112, 73)	55.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception	Cluster 2, Satisfied (n=26, 38)	52.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception	Cluster 3, Not Satisfied (n=25, 44)	54.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception	Cluster 1, Very Satisfied (n=112, 73)	55.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception	Cluster 2, Satisfied (n=26, 38)	53.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception	Cluster 3, Not Satisfied (n=25, 44)	48.4 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.934Cochran-Mantel-Haenszel

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.656Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 2 DMARDs was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 2 DMARDs, who reported themselves as very satisfied, satisfied, or not satisfied. n=number of participants receiving only 2 DMARDs who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception	Cluster 1, Very Satisfied (n=77, 49)	38.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception	Cluster 2, Satisfied (n=21, 26)	42.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception	Cluster 3, Not Satisfied (n=19, 40)	41.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception	Cluster 1, Very Satisfied (n=77, 49)	37.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception	Cluster 2, Satisfied (n=21, 26)	36.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception	Cluster 3, Not Satisfied (n=19, 40)	44.0 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.934Cochran-Mantel-Haenszel

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.656Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 3 DMARDs was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 3 DMARDs who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants receiving only 3 DMARDs who reported themselves as very satisfied, satisfied , or not satisfied for the specified treatment arm.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception	Cluster 1, Very Satisfied (n=9, 10)	4.5 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception	Cluster 2, Satisfied (n=3, 7)	6.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception	Cluster 3, Not Satisfied (n=2, 7)	4.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception	Cluster 1, Very Satisfied (n=9, 10)	7.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception	Cluster 2, Satisfied (n=3, 7)	9.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception	Cluster 3, Not Satisfied (n=2, 7)	7.7 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.934Cochran-Mantel-Haenszel

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.656Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q10: How Much Do You Think Injecting Etanercept Will Interfere with Travelling on Holiday/ Business/Visiting? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	1=A little	20.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	3=A lot	7.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	2=Somewhat	9.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	4=Very much	2.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	0=Not at all	60.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	4=Very much	3.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	0=Not at all	48.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	1=A little	23.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	2=Somewhat	17.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84	3=A lot	7.7 percentage of participants

p-value: 0.00295% CI: [1.21, 2.24]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q11: Overall, How Confident Are You in Your Management of Your Weekly Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	1=A little	1.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	3=A lot	22.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	2=Somewhat	6.2 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	4=Very much	67.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	0=Not at all	2.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	4=Very much	53.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	0=Not at all	2.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	1=A little	5.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	2=Somewhat	8.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84	3=A lot	30.4 percentage of participants

p-value: <0.00195% CI: [0.41, 0.78]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q12: How Confident Are You That You Inject the Right Amount of Medicine Every Time? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	1=A little	2.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	3=A lot	17.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	2=Somewhat	5.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	4=Very much	73.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	0=Not at all	1.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	4=Very much	65.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	0=Not at all	1.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	1=A little	5.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	2=Somewhat	7.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84	3=A lot	21.3 percentage of participants

p-value: 0.02295% CI: [0.47, 0.94]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q13: How Confident Are You That You Can Inject Yourself Properly with the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	1=A little	3.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	3=A lot	17.2 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	2=Somewhat	5.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	4=Very much	71.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	0=Not at all	3.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	4=Very much	60.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	0=Not at all	1.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	1=A little	6.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	2=Somewhat	8.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84	3=A lot	23.4 percentage of participants

p-value: 0.00995% CI: [0.46, 0.89]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q14: Are You Confident That You Have Good Control over the Injection Process? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	1=A little	2.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	3=A lot	17.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	2=Somewhat	5.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	4=Very much	72.5 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	0=Not at all	2.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	4=Very much	61.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	0=Not at all	1.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	1=A little	4.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	2=Somewhat	7.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84	3=A lot	25.1 percentage of participants

p-value: 0.00795% CI: [0.45, 0.88]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q15: How Confident Are You That You Injected Yourself Successfully? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	1=A little	2.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	3=A lot	20.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	2=Somewhat	4.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	4=Very much	70.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	0=Not at all	2.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	4=Very much	60.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	0=Not at all	1.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	1=A little	3.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	2=Somewhat	8.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84	3=A lot	25.8 percentage of participants

p-value: 0.01495% CI: [0.47, 0.92]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q16: Overall, How Nervous Do You Feel about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	1=A little	19.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	3=A lot	3.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	2=Somewhat	8.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	4=Very much	1.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	0=Not at all	66.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	4=Very much	3.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	0=Not at all	49.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	1=A little	25.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	2=Somewhat	15.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84	3=A lot	7.0 percentage of participants

p-value: <0.00195% CI: [1.53, 2.88]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q17: Overall, How Nervous Do You Feel about Inserting the Needle into Your Skin? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	1=A little	21.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	3=A lot	5.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	2=Somewhat	6.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	4=Very much	1.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	0=Not at all	64.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	4=Very much	5.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	0=Not at all	45.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	1=A little	27.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	2=Somewhat	12.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84	3=A lot	8.4 percentage of participants

p-value: <0.00195% CI: [1.57, 2.91]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q18: Do You Dislike Injecting Yourself with this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	1=A little	17.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	3=A lot	3.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	2=Somewhat	6.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	4=Very much	1.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	0=Not at all	70.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	4=Very much	8.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	0=Not at all	46.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	1=A little	22.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	2=Somewhat	14.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84	3=A lot	9.7 percentage of participants

p-value: <0.00195% CI: [2.23, 4.25]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q19: Overall, Are You Emotionally Distressed or Anxious about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	1=A little	18.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	3=A lot	2.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	2=Somewhat	7.2 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	4=Very much	2.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	0=Not at all	70.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	4=Very much	5.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	0=Not at all	57.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	1=A little	22.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	2=Somewhat	8.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84	3=A lot	6.4 percentage of participants

p-value: <0.00195% CI: [1.35, 2.62]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q1: Overall, How Easy Was It to Perform an Injection with this Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	1=Easy	17.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	3=Difficult	4.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	2=Neither Easy nor Difficult	7.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	4=Very Difficult	1.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	0=Very Easy	69.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	4=Very Difficult	1.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	0=Very Easy	54.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	1=Easy	26.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	2=Neither Easy nor Difficult	12.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84	3=Difficult	5.4 percentage of participants

Comparison: Day 84p-value: <0.00195% CI: [1.33, 2.57]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q20: How Much Do You Like the Look of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	1=A little	3.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	3=A lot	32.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	2=Somewhat	19.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	4=Very much	42.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	0=Not at all	1.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	4=Very much	18.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	0=Not at all	10.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	1=A little	10.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	2=Somewhat	35.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84	3=A lot	24.8 percentage of participants

p-value: <0.00195% CI: [0.18, 0.34]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q21: How Much Do You Like the Feel of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	1=A little	3.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	3=A lot	33.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	2=Somewhat	20.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	4=Very much	40.5 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	0=Not at all	3.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	4=Very much	17.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	0=Not at all	9.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	1=A little	10.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	2=Somewhat	35.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84	3=A lot	27.0 percentage of participants

p-value: <0.00195% CI: [0.19, 0.36]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q22: How Much Does the Device Look Like Something You Would Feel Comfortable to Use? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	1=A little	3.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	3=A lot	27.5 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	2=Somewhat	18.2 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	4=Very much	46.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	0=Not at all	4.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	4=Very much	18.5 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	0=Not at all	12.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	1=A little	8.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	2=Somewhat	31.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84	3=A lot	29.0 percentage of participants

p-value: <0.00195% CI: [0.2, 0.36]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: Side Effects from Using the Device - Q23: Do You Experience Pain During or Immediately After the Injection? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	1=A little	28.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	3=A lot	11.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	2=Somewhat	20.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	4=Very much	3.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	0=Not at all	36.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	4=Very much	3.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	0=Not at all	39.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	1=A little	29.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	2=Somewhat	17.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84	3=A lot	9.1 percentage of participants

p-value: 0.19695% CI: [0.61, 1.11]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q24: To What Extent Would You Consider Alternative Devices If You Were to Continue on Etanercept? Participants specified their responses on a 5-point Likert scale: 0=very little to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	1=A little	8.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	3=A lot	8.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	2=Somewhat	20.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	4=Very much	13.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	0=Very little	48.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	4=Very much	16.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	0=Very little	28.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	1=A little	21.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	2=Somewhat	22.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84	3=A lot	11.2 percentage of participants

p-value: 0.00195% CI: [1.25, 2.42]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q25: Would You Recommend this Device to Someone Else Who Needed to Self Inject? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=yes definitely.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	1=Rarely	2.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	3=Often	12.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	2=Occasionally	7.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	4=Yes definitely	74.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	0=Not at all	3.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	4=Yes definitely	46.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	0=Not at all	4.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	1=Rarely	5.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	2=Occasionally	24.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84	3=Often	19.3 percentage of participants

p-value: <0.00195% CI: [0.21, 0.42]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q26: If Your Doctor Advised You to, How Likely Would You to Be Continue Injecting Regularly With this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very likely.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	1=Usually not	3.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	3=Likely	11.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	2=Occasionally	9.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	4=Very likely	73.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	0=Not at all	3.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	4=Very likely	51.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	0=Not at all	3.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	1=Usually not	7.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	2=Occasionally	17.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84	3=Likely	18.9 percentage of participants

p-value: <0.00195% CI: [0.29, 0.56]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q2: How Easy Was It to Learn to Use the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	1=Easy	15.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	3=Difficult	1.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	2=Neither Easy nor Difficult	5.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	4=Very Difficult	1.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	0=Very Easy	75.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	4=Very Difficult	0.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	0=Very Easy	62.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	1=Easy	30.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	2=Neither Easy nor Difficult	5.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84	3=Difficult	1.0 percentage of participants

p-value: 0.00795% CI: [1.14, 2.29]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q3: How Easy Is It to Dispose Of the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	1=Easy	10.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	3=Difficult	1.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	2=Neither Easy nor Difficult	2.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	4=Very Difficult	0.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	0=Very Easy	85.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	4=Very Difficult	0.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	0=Very Easy	74.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	1=Easy	19.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	2=Neither Easy nor Difficult	4.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84	3=Difficult	1.0 percentage of participants

p-value: 0.00295% CI: [1.26, 2.92]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q4: How Easy Is It to Know When the Injection Is Completed? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	1=Easy	13.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	3=Difficult	2.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	2=Neither Easy nor Difficult	2.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	4=Very Difficult	0.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	0=Very Easy	81.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	4=Very Difficult	0.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	0=Very Easy	63.4 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	1=Easy	26.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	2=Neither Easy nor Difficult	7.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84	3=Difficult	2.4 percentage of participants

p-value: <0.00195% CI: [1.65, 3.46]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q5: How Easy Is It to Hold the Device Whilst Injecting? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	1=Easy	23.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	3=Difficult	2.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	2=Neither Easy nor Difficult	7.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	4=Very Difficult	2.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	0=Very Easy	63.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	4=Very Difficult	2.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	0=Very Easy	47.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	1=Easy	26.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	2=Neither Easy nor Difficult	16.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84	3=Difficult	7.1 percentage of participants

p-value: <0.00195% CI: [1.5, 2.83]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q6: Did You Feel any Hand Discomfort Whilst Using the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	1=Easy	18.5 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	3=Difficult	3.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	2=Neither Easy nor Difficult	7.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	4=Very Difficult	1.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	0=Very Easy	69.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	4=Very Difficult	3.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	0=Very Easy	54.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	1=Easy	19.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	2=Neither Easy nor Difficult	15.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84	3=Difficult	7.6 percentage of participants

p-value: <0.00195% CI: [1.44, 2.78]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q7: How Long Does It Take to Perform the Injection, Including any Preparation and Disposal? Participants specified their responses on a 5-point Likert scale: 0=\<5 minutes to 4=\>30 minutes.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	5-10 minutes	22.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	21-30 minutes	5.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	11-20 minutes	6.8 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	>30 minutes	1.4 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	<5 minutes	64.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	>30 minutes	1.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	<5 minutes	57.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	5-10 minutes	30.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	11-20 minutes	6.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84	21-30 minutes	3.7 percentage of participants

p-value: 0.18495% CI: [0.9, 1.72]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q8: How Much Do You Think Injecting Etanercept Will Interfere with Your Ability to Enjoy Social or Leisure Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	1=A little	14.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	3=A lot	4.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	2=Somewhat	7.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	4=Very much	3.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	0=Not at all	71.1 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	4=Very much	2.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	0=Not at all	64.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	1=A little	17.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	2=Somewhat	11.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84	3=A lot	4.7 percentage of participants

p-value: 0.10695% CI: [0.94, 1.85]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84

Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q9: Do You Think Injecting Etanercept Will Interfere with Your Usual Daily Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.

Time frame: Day 84

Population: mITT. N=participants with evaluable data.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	1=A little	12.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	3=A lot	2.3 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	2=Somewhat	5.6 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	4=Very much	1.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	0=Not at all	78.8 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	4=Very much	1.0 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	0=Not at all	73.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	1=A little	15.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	2=Somewhat	5.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84	3=A lot	4.3 percentage of participants

p-value: 0.11295% CI: [0.93, 1.96]GEE model+logit link+multinomial distrib

Secondary

Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants with only reading/writing capacity was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	35.0 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception	Cluster 2, Satisfied (n=51, 70)	45.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	36.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	44.7 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception	Cluster 2, Satisfied (n=51, 70)	42.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	33.7 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.652Chi-squared

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.459Chi-squared

Secondary

Percentage of Participants With Prior Injection Experience Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants with prior injection experience was determined for each cluster of participants.

Time frame: Day 84

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants With Prior Injection Experience Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	52.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants With Prior Injection Experience Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	47.1 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants With Prior Injection Experience Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	70.2 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Prior Injection Experience Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	54.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Prior Injection Experience Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	54.9 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Prior Injection Experience Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	59.8 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.049Chi-squared

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.736Chi-squared

Secondary

Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The percentage of participants with prior self-injection experience was determined for each cluster of participants.

Time frame: Day 84

Arm	Measure	Group	Value (NUMBER)
Enbrel 50 mg Autoinjector	Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	31.9 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	15.7 percentage of participants
Enbrel 50 mg Autoinjector	Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	38.3 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	31.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	36.6 percentage of participants
Enbrel 50 mg Prefilled Syringe	Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	31.5 percentage of participants

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.033Chi-squared

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.73Chi-squared

Secondary

Physician's Global Assessment of RA Activity Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean Physician's Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).

Time frame: Day 84

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Physician's Global Assessment of RA Activity Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	58.8 millimeters on the VAS	Standard Deviation 18.6
Enbrel 50 mg Autoinjector	Physician's Global Assessment of RA Activity Associated With Participant Perception	Cluster 2, Satisfied (n=50, 71)	58.3 millimeters on the VAS	Standard Deviation 18.3
Enbrel 50 mg Autoinjector	Physician's Global Assessment of RA Activity Associated With Participant Perception	Cluster 3, Not Satisfied (n=46, 92)	60.3 millimeters on the VAS	Standard Deviation 16.8
Enbrel 50 mg Prefilled Syringe	Physician's Global Assessment of RA Activity Associated With Participant Perception	Cluster 1, Very Satisfied (n=203, 132)	60.8 millimeters on the VAS	Standard Deviation 19
Enbrel 50 mg Prefilled Syringe	Physician's Global Assessment of RA Activity Associated With Participant Perception	Cluster 2, Satisfied (n=50, 71)	57.4 millimeters on the VAS	Standard Deviation 21.6
Enbrel 50 mg Prefilled Syringe	Physician's Global Assessment of RA Activity Associated With Participant Perception	Cluster 3, Not Satisfied (n=46, 92)	60.1 millimeters on the VAS	Standard Deviation 16.6

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.843ANOVA

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.461ANOVA

Secondary

RA Duration Associated With Participant Perception

Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean RA Duration was determined for each cluster of participants.

Time frame: Day 84

Population: mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.

Arm	Measure	Group	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	RA Duration Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	8.6 years	Standard Deviation 8
Enbrel 50 mg Autoinjector	RA Duration Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	9.4 years	Standard Deviation 8.2
Enbrel 50 mg Autoinjector	RA Duration Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	8.9 years	Standard Deviation 8.9
Enbrel 50 mg Prefilled Syringe	RA Duration Associated With Participant Perception	Cluster 1, Very Satisfied (n=204, 133)	9.7 years	Standard Deviation 9.1
Enbrel 50 mg Prefilled Syringe	RA Duration Associated With Participant Perception	Cluster 2, Satisfied (n=51, 71)	8.6 years	Standard Deviation 8.1
Enbrel 50 mg Prefilled Syringe	RA Duration Associated With Participant Perception	Cluster 3, Not Satisfied (n=47, 92)	10.3 years	Standard Deviation 8.4

Comparison: p-value for statistical difference between 3 clusters in the Autoinjector groupp-value: 0.838ANOVA

Comparison: p-value for statistical difference between 3 clusters in the Prefilled Syringe groupp-value: 0.483ANOVA

Secondary

Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score

The SF-STAI consisted of 6 questions, each scored from 1 to 4. Total score ranged from 6=less anxiety to 24=more anxiety. Higher score indicated that the participant was more anxious.

Time frame: Day 84

Population: mITT. N=number of evaluable participants.

Arm	Measure	Value (MEAN)	Dispersion
Enbrel 50 mg Autoinjector	Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score	10.0 units on a scale	Standard Deviation 3.7
Enbrel 50 mg Prefilled Syringe	Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score	10.5 units on a scale	Standard Deviation 3.4

p-value: 0.15495% CI: [-0.97, 0.15]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population

Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population

Age Associated With Participant Perception

DAS28 Score Associated With Participant Perception

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?

Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?

HAD Anxiety Subscale Score Associated With Participant Perception

HAD Depression Subscale Score Associated With Participant Perception

HAQ-DI Score Associated With Participant Perception

PAM Score Associated With Participant Perception

Participant Satisfaction at Endpoint Associated With Participant Perception

Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept

Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept

Participant's Global Assessment of RA Activity Associated With Participant Perception

Percentage of Female Participants Associated With Participant Perception

Percentage of Male Participants Associated With Participant Perception

Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception

Percentage of Participants at University Level Associated With Participant Perception

Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept

Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept

Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception

Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception

Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84

Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84