Trial Outcomes & Findings for Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (NCT NCT00482170)
NCT ID: NCT00482170
Last Updated: 2012-03-30
Results Overview
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
421 participants
Primary outcome timeframe
Week 12
Results posted on
2012-03-30
Participant Flow
Participant milestones
| Measure |
Etanercept 50 mg Auto-injector
Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
214
|
|
Overall Study
Treated
|
207
|
211
|
|
Overall Study
COMPLETED
|
192
|
194
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
Reasons for withdrawal
| Measure |
Etanercept 50 mg Auto-injector
Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
14
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Unspecified reason
|
0
|
2
|
Baseline Characteristics
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
Baseline characteristics by cohort
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
Total
n=417 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.1 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Modified intent-to-treat (mITT) analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=198 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=197 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
|
8.9 units on a scale
Standard Deviation 1.9
|
7.6 units on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Week 12Population: Per-protocol (PP) analysis population included participants from mITT population who completed the study with no major protocol violations. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=189 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=186 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population
|
9.0 units on a scale
Standard Deviation 1.9
|
7.5 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Participant satisfaction was assessed by asking the question "Are you satisfied with your injection device? and using a dichotomous response: Yes or No.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Satisfied With Injection Device
Week 12 (n=188, 179)
|
98.4 percentage of participants
|
88.8 percentage of participants
|
|
Percentage of Participants Satisfied With Injection Device
Baseline- After the training (n=198, 199)
|
99.5 percentage of participants
|
92.5 percentage of participants
|
|
Percentage of Participants Satisfied With Injection Device
Week 4 (n=190, 190)
|
98.9 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants Satisfied With Injection Device
Last Observation (n=206, 210)
|
98.5 percentage of participants
|
88.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Last observation carried forward (LOCF) method was used to impute missing values.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=\<) 36 years, greater than (\>) 36 years to 45 years, \> 45 years to 55 years, \> 55 years.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Age on Participant Satisfaction With Injection Device
=< 36 years
|
8.94 units on a scale
Standard Deviation 1.95
|
7.18 units on a scale
Standard Deviation 2.62
|
|
Influence of Age on Participant Satisfaction With Injection Device
> 36 years to 45 years
|
8.91 units on a scale
Standard Deviation 1.52
|
7.41 units on a scale
Standard Deviation 2.39
|
|
Influence of Age on Participant Satisfaction With Injection Device
> 45 years to 55 years
|
9.06 units on a scale
Standard Deviation 1.89
|
7.93 units on a scale
Standard Deviation 2.90
|
|
Influence of Age on Participant Satisfaction With Injection Device
> 55 years
|
8.82 units on a scale
Standard Deviation 2.12
|
8.07 units on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Gender on Participant Satisfaction With Injection Device
Male
|
9.07 units on a scale
Standard Deviation 1.59
|
7.60 units on a scale
Standard Deviation 2.57
|
|
Influence of Gender on Participant Satisfaction With Injection Device
Female
|
8.70 units on a scale
Standard Deviation 2.31
|
7.68 units on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Socio-educational Status on Participant Satisfaction With Injection Device
Reading /Writing capacity
|
9.22 units on a scale
Standard Deviation 1.62
|
7.96 units on a scale
Standard Deviation 2.49
|
|
Influence of Socio-educational Status on Participant Satisfaction With Injection Device
High school /Baccalaureate level
|
8.80 units on a scale
Standard Deviation 1.97
|
7.55 units on a scale
Standard Deviation 2.73
|
|
Influence of Socio-educational Status on Participant Satisfaction With Injection Device
University level
|
8.89 units on a scale
Standard Deviation 2.01
|
7.24 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =\< 4, \> 4 to 7, \> 7 to 10, \> 10 for HAD-A and =\< 3, \> 3 to 5, \> 5 to 8, \> 8 for HAD-D.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-A: =< 4
|
8.98 units on a scale
Standard Deviation 1.77
|
7.83 units on a scale
Standard Deviation 2.42
|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-A: > 4 to 7
|
9.17 units on a scale
Standard Deviation 1.48
|
7.49 units on a scale
Standard Deviation 2.65
|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-A: > 7 to 10
|
8.89 units on a scale
Standard Deviation 2.27
|
7.42 units on a scale
Standard Deviation 2.88
|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-A: > 10
|
8.73 units on a scale
Standard Deviation 1.92
|
7.74 units on a scale
Standard Deviation 2.44
|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-D: =< 3
|
8.68 units on a scale
Standard Deviation 2.19
|
7.93 units on a scale
Standard Deviation 2.39
|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-D: > 3 to 5
|
9.15 units on a scale
Standard Deviation 2.04
|
7.57 units on a scale
Standard Deviation 2.42
|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-D: > 5 to 8
|
9.20 units on a scale
Standard Deviation 1.02
|
7.50 units on a scale
Standard Deviation 2.50
|
|
Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device
HAD-D: > 8
|
8.90 units on a scale
Standard Deviation 1.92
|
7.31 units on a scale
Standard Deviation 3.09
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =\< 47.4, \> 47.4 to 56.4, \> 56.4 to 68.5, \> 68.5.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
=< 47.4
|
8.73 units on a scale
Standard Deviation 1.90
|
7.05 units on a scale
Standard Deviation 2.76
|
|
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
> 47.4 to 56.4
|
9.41 units on a scale
Standard Deviation 1.14
|
7.94 units on a scale
Standard Deviation 2.17
|
|
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
> 56.4 to 68.5
|
8.28 units on a scale
Standard Deviation 2.68
|
7.94 units on a scale
Standard Deviation 2.70
|
|
Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device
> 68.5
|
9.11 units on a scale
Standard Deviation 1.73
|
7.93 units on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device
Yes
|
8.89 units on a scale
Standard Deviation 1.92
|
7.53 units on a scale
Standard Deviation 2.74
|
|
Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device
No
|
8.96 units on a scale
Standard Deviation 1.87
|
7.66 units on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =\< 11 years, \> 11 years to 19 years, \> 19 years to 28 years, \> 28 years.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
=< 11 years
|
9.09 units on a scale
Standard Deviation 1.56
|
7.90 units on a scale
Standard Deviation 2.22
|
|
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
> 11 years to 19 years
|
8.74 units on a scale
Standard Deviation 1.99
|
7.17 units on a scale
Standard Deviation 2.67
|
|
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
> 19 years to 28 years
|
9.12 units on a scale
Standard Deviation 1.65
|
7.72 units on a scale
Standard Deviation 2.76
|
|
Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device
> 28 years
|
8.82 units on a scale
Standard Deviation 2.29
|
7.76 units on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =\< 3, \> 3 to 4, \> 4.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
=< 3
|
8.87 units on a scale
Standard Deviation 1.91
|
7.51 units on a scale
Standard Deviation 2.48
|
|
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
> 3 to 4
|
8.96 units on a scale
Standard Deviation 1.97
|
7.79 units on a scale
Standard Deviation 2.79
|
|
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device
> 4
|
9.62 units on a scale
Standard Deviation 0.51
|
7.83 units on a scale
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =\< 11.2, \> 11.2 to 16.2, \> 16.2 to 21.9, \> 21.9.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
=< 11.2
|
8.41 units on a scale
Standard Deviation 2.26
|
7.45 units on a scale
Standard Deviation 2.33
|
|
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
> 11.2 to 16.2
|
9.17 units on a scale
Standard Deviation 1.97
|
7.81 units on a scale
Standard Deviation 2.78
|
|
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
> 16.2 to 21.9
|
9.11 units on a scale
Standard Deviation 1.66
|
7.67 units on a scale
Standard Deviation 2.49
|
|
Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device
> 21.9
|
9.00 units on a scale
Standard Deviation 1.57
|
7.67 units on a scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =\< 48, \> 48 to 67.25, \> 67.25 to 84, \> 84.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
=< 48
|
8.54 units on a scale
Standard Deviation 2.36
|
7.06 units on a scale
Standard Deviation 3.26
|
|
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
> 48 to 67.25
|
9.15 units on a scale
Standard Deviation 1.24
|
7.79 units on a scale
Standard Deviation 2.61
|
|
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
> 67.25 to 84
|
8.70 units on a scale
Standard Deviation 2.22
|
7.72 units on a scale
Standard Deviation 2.06
|
|
Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device
> 84
|
9.42 units on a scale
Standard Deviation 1.20
|
7.85 units on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =\< 63, \> 63 to 76, \> 76 to 88, \> 88.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
=< 63
|
8.79 units on a scale
Standard Deviation 1.54
|
7.96 units on a scale
Standard Deviation 2.18
|
|
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
> 63 to 76
|
9.02 units on a scale
Standard Deviation 1.91
|
7.51 units on a scale
Standard Deviation 2.80
|
|
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
> 76 to 88
|
8.71 units on a scale
Standard Deviation 2.19
|
7.70 units on a scale
Standard Deviation 2.55
|
|
Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device
> 88
|
9.20 units on a scale
Standard Deviation 1.90
|
7.33 units on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =\< 8, \> 8 to 13, \> 13 to 18, \> 18.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
=< 8
|
8.82 units on a scale
Standard Deviation 2.18
|
7.82 units on a scale
Standard Deviation 2.23
|
|
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
> 8 to 13
|
8.94 units on a scale
Standard Deviation 1.70
|
7.71 units on a scale
Standard Deviation 2.53
|
|
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
> 13 to 18
|
8.81 units on a scale
Standard Deviation 2.04
|
7.37 units on a scale
Standard Deviation 2.72
|
|
Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device
> 18
|
9.14 units on a scale
Standard Deviation 1.67
|
7.55 units on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Co-morbidities on Participant Satisfaction With Injection Device
Current tobacco usage: Yes
|
8.94 units on a scale
Standard Deviation 2.11
|
7.40 units on a scale
Standard Deviation 2.60
|
|
Influence of Co-morbidities on Participant Satisfaction With Injection Device
Current tobacco usage: No
|
8.95 units on a scale
Standard Deviation 1.70
|
7.76 units on a scale
Standard Deviation 2.58
|
|
Influence of Co-morbidities on Participant Satisfaction With Injection Device
Current alcohol usage: Yes
|
8.96 units on a scale
Standard Deviation 1.93
|
8.06 units on a scale
Standard Deviation 2.06
|
|
Influence of Co-morbidities on Participant Satisfaction With Injection Device
Current alcohol usage: No
|
8.94 units on a scale
Standard Deviation 1.84
|
7.33 units on a scale
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device
Yes
|
8.95 units on a scale
Standard Deviation 1.87
|
7.61 units on a scale
Standard Deviation 2.59
|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device
No
|
NA units on a scale
Standard Deviation NA
Data was not analyzed because all the participants had received prior systemic or topical medication.
|
9.00 units on a scale
Standard Deviation NA
Data was not available because there was only 1 participant who did not receive any prior systemic or topical medication.
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.
Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Prior Injection Experience on Participant Satisfaction With Injection Device
Yes
|
9.05 units on a scale
Standard Deviation 1.66
|
7.70 units on a scale
Standard Deviation 2.58
|
|
Influence of Prior Injection Experience on Participant Satisfaction With Injection Device
No
|
8.88 units on a scale
Standard Deviation 2.01
|
7.56 units on a scale
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Ease of use of injection device was assessed by participant's response to question, "How easy was it to perform an injection with this device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 4: 2 (n=180, 190)
|
6 participants
|
20 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 4: 3 (n=180, 190)
|
2 participants
|
12 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 4: 4 (n=180, 190)
|
4 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 12: 0 (n=194, 195)
|
149 participants
|
109 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 12: 1 (n=194, 195)
|
35 participants
|
54 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 12: 2 (n=194, 195)
|
4 participants
|
18 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 12: 3 (n=194, 195)
|
4 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 12: 4 (n=194, 195)
|
2 participants
|
5 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Last observation: 0 (n=202, 207)
|
153 participants
|
115 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Last observation: 1 (n=202, 207)
|
36 participants
|
58 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Last observation: 2 (n=202, 207)
|
4 participants
|
19 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Last observation: 3 (n=202, 207)
|
5 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Last observation: 4 (n=202, 207)
|
4 participants
|
6 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Baseline- After the training: 0 (n=202, 208)
|
134 participants
|
92 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Baseline- After the training: 1 (n=202, 208)
|
50 participants
|
72 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Baseline- After the training: 2 (n=202, 208)
|
15 participants
|
33 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Baseline- After the training: 3 (n=202, 208)
|
3 participants
|
7 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Baseline- After the training: 4 (n=202, 208)
|
0 participants
|
4 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 4: 0 (n=180, 190)
|
126 participants
|
94 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device
Week 4: 1 (n=180, 190)
|
42 participants
|
62 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Ease of use of injection device was assessed by participant's response to question, "How easy was it to use the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Baseline- After the training: 1 (n=201, 208)
|
39 participants
|
57 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Baseline- After the training: 2 (n=201, 208)
|
7 participants
|
13 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Baseline- After the training: 0 (n=201, 208)
|
154 participants
|
132 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Baseline- After the training: 3 (n=201, 208)
|
1 participants
|
5 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Baseline- After the training: 4 (n=201, 208)
|
0 participants
|
1 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 4: 0 (n=179, 189)
|
137 participants
|
122 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 4: 1 (n=179, 189)
|
32 participants
|
54 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 4: 2 (n=179, 189)
|
4 participants
|
6 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 4: 3 (n=179, 189)
|
1 participants
|
4 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 4: 4 (n=179, 189)
|
5 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 12: 0 (n=189, 195)
|
154 participants
|
126 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 12: 1 (n=189, 195)
|
26 participants
|
54 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 12: 2 (n=189, 195)
|
4 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 12: 3 (n=189, 195)
|
2 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Week 12: 4 (n=189, 195)
|
3 participants
|
4 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Last observation: 0 (n=201, 207)
|
161 participants
|
134 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Last observation: 1 (n=201, 207)
|
26 participants
|
57 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Last observation: 2 (n=201, 207)
|
6 participants
|
10 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Last observation: 3 (n=201, 207)
|
5 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device
Last observation: 4 (n=201, 207)
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Ease of use of injection device was assessed by participant's response to question, "How easy was it to dispose of the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Baseline- After the training: 0 (n=198, 205)
|
158 participants
|
141 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Baseline- After the training: 1 (n=198, 205)
|
25 participants
|
47 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Baseline- After the training: 2 (n=198, 205)
|
12 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Baseline- After the training: 3 (n=198, 205)
|
3 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Baseline- After the training: 4 (n=198, 205)
|
0 participants
|
6 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 4: 0 (n=173, 189)
|
131 participants
|
142 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 4: 1 (n=173, 189)
|
29 participants
|
34 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 4: 2 (n=173, 189)
|
5 participants
|
5 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 4: 3 (n=173, 189)
|
4 participants
|
5 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 4: 4 (n=173, 189)
|
4 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 12: 0 (n=187, 195)
|
150 participants
|
148 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 12: 1 (n=187, 195)
|
21 participants
|
34 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 12: 2 (n=187, 195)
|
6 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 12: 3 (n=187, 195)
|
4 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Week 12: 4 (n=187, 195)
|
6 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Last observation: 0 (n=202, 210)
|
161 participants
|
161 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Last observation: 1 (n=202, 210)
|
23 participants
|
36 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Last observation: 2 (n=202, 210)
|
6 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Last observation: 3 (n=202, 210)
|
5 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device
Last observation: 4 (n=202, 210)
|
7 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Ease of use of injection device was assessed by participant's response to question, "How easy is it to know when the injection is completed?" scored on a 5-point Likert scale (0= very easy to 4= very difficult).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Baseline- After the training: 0 (n=201, 207)
|
140 participants
|
129 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Baseline- After the training: 1 (n=201, 207)
|
44 participants
|
62 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Baseline- After the training: 2 (n=201, 207)
|
13 participants
|
10 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Baseline- After the training: 3 (n=201, 207)
|
3 participants
|
4 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Baseline- After the training: 4 (n=201, 207)
|
1 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 4: 0 (n=175, 189)
|
124 participants
|
123 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 4: 1 (n=175, 189)
|
40 participants
|
50 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 4: 2 (n=175, 189)
|
5 participants
|
8 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 4: 3 (n=175, 189)
|
2 participants
|
5 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 4: 4 (n=175, 189)
|
4 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 12: 0 (n=194, 192)
|
147 participants
|
137 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 12: 1 (n=194, 192)
|
40 participants
|
38 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 12: 2 (n=194, 192)
|
4 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 12: 3 (n=194, 192)
|
0 participants
|
6 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Week 12: 4 (n=194, 192)
|
3 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Last Observation: 0 (n=204, 210)
|
155 participants
|
151 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Last Observation: 1 (n=204, 210)
|
42 participants
|
42 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Last Observation: 2 (n=204, 210)
|
4 participants
|
9 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Last Observation: 3 (n=204, 210)
|
0 participants
|
6 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete
Last Observation: 4 (n=204, 210)
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Ease of use of injection device was assessed by participant's response to question, "How easy is it to hold the device whilst injecting?" scored on a 5-point Likert scale (0= very easy to 4= very difficult)
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Baseline- After the training: 0 (n=199, 206)
|
134 participants
|
100 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Baseline- After the training: 1 (n=199, 206)
|
48 participants
|
72 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Baseline- After the training: 2 (n=199, 206)
|
15 participants
|
24 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Baseline- After the training: 3 (n=199, 206)
|
2 participants
|
8 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Baseline- After the training: 4 (n=199, 206)
|
0 participants
|
2 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 4: 0 (n=179, 190)
|
114 participants
|
83 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 4: 1 (n=179, 190)
|
45 participants
|
59 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 4: 2 (n=179, 190)
|
14 participants
|
33 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 4: 3 (n=179, 190)
|
3 participants
|
12 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 4: 4 (n=179, 190)
|
3 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 12: 0 (n=193, 196)
|
133 participants
|
101 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 12: 1 (n=193, 196)
|
51 participants
|
55 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 12: 2 (n=193, 196)
|
4 participants
|
27 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 12: 3 (n=193, 196)
|
1 participants
|
10 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Week 12: 4 (n=193, 196)
|
4 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Last observation: 0 (n=203, 209)
|
140 participants
|
105 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Last observation: 1 (n=203, 209)
|
52 participants
|
61 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Last observation: 2 (n=203, 209)
|
6 participants
|
29 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Last observation: 3 (n=203, 209)
|
1 participants
|
11 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting
Last observation: 4 (n=203, 209)
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Ease of use of injection device was assessed by participant's response to question, "Did you feel any hand discomfort whilst using the device?" scored on a 5-point Likert scale (0= none to 4= extreme).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Baseline- After the training: 0 (n=197, 208)
|
158 participants
|
131 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Baseline- After the training: 1 (n=197, 208)
|
26 participants
|
44 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Baseline- After the training: 2 (n=197, 208)
|
6 participants
|
20 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Baseline- After the training: 3 (n=197, 208)
|
3 participants
|
10 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Baseline- After the training: 4 (n=197, 208)
|
4 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 4: 0 (n=176, 188)
|
144 participants
|
114 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 4: 1 (n=176, 188)
|
18 participants
|
37 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 4: 2 (n=176, 188)
|
7 participants
|
26 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 4: 3 (n=176, 188)
|
7 participants
|
8 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 4: 4 (n=176, 188)
|
0 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 12: 0 (n=193, 195)
|
159 participants
|
125 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 12: 1 (n=193, 195)
|
24 participants
|
45 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 12: 2 (n=193, 195)
|
7 participants
|
15 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 12: 3 (n=193, 195)
|
2 participants
|
7 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Week 12: 4 (n=193, 195)
|
1 participants
|
3 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Last observation: 0 (n=204, 210)
|
168 participants
|
138 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Last observation: 1 (n=204, 210)
|
25 participants
|
46 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Last observation: 2 (n=204, 210)
|
8 participants
|
15 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Last observation: 3 (n=204, 210)
|
2 participants
|
8 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting
Last observation: 4 (n=204, 210)
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.
Ease of Use of Injection Device was assessed by participant's response to question, "How long does it take to perform the injection, including any preparation and disposal?" where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Baseline- After training: less than 5 (n=200, 206)
|
132 participants
|
129 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Baseline- After training: 5 to10 (n=200, 206)
|
43 participants
|
56 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Baseline- After training: 11 to 20 (n=200, 206)
|
12 participants
|
14 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Baseline- After training: 21 to 30 (n=200, 206)
|
9 participants
|
7 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Baseline- After training:more than 30 (n=200, 206)
|
4 participants
|
0 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 4: less than 5 (n=180, 189)
|
117 participants
|
121 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 4: 5 to 10 (n=180, 189)
|
36 participants
|
41 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 4: 11 to 20 (n=180, 189)
|
14 participants
|
16 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 4: 21 to 30 (n=180, 189)
|
8 participants
|
10 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 4: more than 30 (n=180, 189)
|
5 participants
|
1 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 12: less than 5 (n=192, 196)
|
124 participants
|
132 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 12: 5 to 10 (n=192, 196)
|
44 participants
|
40 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 12: 11 to 20 (n=192, 196)
|
12 participants
|
12 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 12: 21 to 30 (n=192, 196)
|
6 participants
|
7 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Week 12: more than 30 (n=192, 196)
|
6 participants
|
5 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Last observation: less than 5 (n=204, 210)
|
131 participants
|
143 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Last observation: 5 to 10 (n=204, 210)
|
48 participants
|
43 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Last observation: 11 to 20 (n=204, 210)
|
12 participants
|
12 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Last observation: 21 to 30 (n=204, 210)
|
7 participants
|
7 participants
|
|
Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)
Last observation: more than 30 (n=204, 210)
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Last observation: 3
|
5 participants
|
7 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Last observation: 4
|
8 participants
|
9 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Baseline- After the training: 0
|
116 participants
|
134 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Baseline- After the training: 1
|
34 participants
|
37 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Baseline- After the training: 2
|
30 participants
|
20 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Baseline- After the training: 3
|
11 participants
|
8 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Baseline- After the training: 4
|
12 participants
|
9 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 4: 0
|
145 participants
|
138 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 4: 1
|
32 participants
|
34 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 4: 2
|
6 participants
|
14 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 4: 3
|
8 participants
|
8 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Last observation: 2
|
8 participants
|
17 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 4: 4
|
5 participants
|
7 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 12: 0
|
133 participants
|
131 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 12: 1
|
44 participants
|
33 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 12: 2
|
8 participants
|
17 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 12: 3
|
4 participants
|
7 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Week 12: 4
|
6 participants
|
9 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Last observation: 0
|
139 participants
|
144 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity
Last observation: 1
|
46 participants
|
34 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Convenience of injection device was assessed by participant's response to question, "Do you think injecting etanercept will interfere with your usual daily activities?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Baseline- After the training: 0
|
134 participants
|
137 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Baseline- After the training: 1
|
45 participants
|
45 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Baseline- After the training: 2
|
14 participants
|
16 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Baseline- After the training: 3
|
6 participants
|
5 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Baseline- After the training: 4
|
3 participants
|
5 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 4: 0
|
150 participants
|
145 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 4: 1
|
35 participants
|
37 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 4: 2
|
4 participants
|
8 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 4: 3
|
3 participants
|
7 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 4: 4
|
2 participants
|
4 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 12: 0
|
147 participants
|
137 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 12: 1
|
40 participants
|
39 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 12: 2
|
6 participants
|
13 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 12: 3
|
0 participants
|
4 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Week 12: 4
|
2 participants
|
5 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Last observation: 0
|
155 participants
|
148 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Last observation: 1
|
42 participants
|
40 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Last observation: 2
|
7 participants
|
13 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Last observation: 3
|
0 participants
|
4 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity
Last observation: 4
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Baseline- After the training: 0
|
105 participants
|
98 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Baseline- After the training: 1
|
48 participants
|
55 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Baseline- After the training: 2
|
34 participants
|
32 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Baseline- After the training: 3
|
13 participants
|
20 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Baseline- After the training: 4
|
3 participants
|
3 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 4: 0
|
101 participants
|
107 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 4: 1
|
46 participants
|
37 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 4: 2
|
34 participants
|
33 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 4: 3
|
9 participants
|
12 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 4: 4
|
3 participants
|
10 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 12: 0
|
109 participants
|
101 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 12: 1
|
44 participants
|
40 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 12: 2
|
33 participants
|
36 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 12: 3
|
5 participants
|
12 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Week 12: 4
|
4 participants
|
8 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Last observation: 0
|
115 participants
|
111 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Last observation: 1
|
46 participants
|
43 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Last observation: 2
|
34 participants
|
37 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Last observation: 3
|
7 participants
|
12 participants
|
|
Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling
Last observation: 4
|
4 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Confidence in injection device was assessed by participant's response to question, "How confident are you in your management of your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Baseline- After the training: 0
|
6 participants
|
11 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Baseline- After the training: 1
|
13 participants
|
20 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Baseline- After the training: 2
|
30 participants
|
31 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Baseline- After the training: 3
|
76 participants
|
78 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Baseline- After the training: 4
|
81 participants
|
67 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 4: 0
|
4 participants
|
3 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 4: 1
|
9 participants
|
8 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 4: 2
|
6 participants
|
10 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 4: 3
|
56 participants
|
75 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 4: 4
|
121 participants
|
105 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 12: 0
|
9 participants
|
1 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 12: 1
|
5 participants
|
7 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 12: 2
|
7 participants
|
12 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 12: 3
|
47 participants
|
60 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Week 12: 4
|
131 participants
|
117 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Last observation: 0
|
9 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Last observation: 1
|
5 participants
|
7 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Last observation: 2
|
7 participants
|
13 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Last observation: 3
|
49 participants
|
67 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections
Last observation: 4
|
136 participants
|
122 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Confidence in injection device was assessed by participant's response to question, "How confident are you that you inject the right amount of medicine every time?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Baseline- After the training: 0
|
5 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Baseline- After the training: 1
|
4 participants
|
7 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Baseline- After the training: 2
|
19 participants
|
15 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Baseline- After the training: 3
|
67 participants
|
54 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Baseline- After the training: 4
|
111 participants
|
129 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 4: 0
|
5 participants
|
3 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 4: 1
|
3 participants
|
6 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 4: 2
|
8 participants
|
3 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 4: 3
|
53 participants
|
50 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 4: 4
|
126 participants
|
139 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 12: 0
|
7 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 12: 1
|
4 participants
|
6 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 12: 2
|
7 participants
|
7 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 12: 3
|
48 participants
|
43 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Week 12: 4
|
132 participants
|
139 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Last observation: 0
|
7 participants
|
3 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Last observation: 1
|
4 participants
|
6 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Last observation: 2
|
8 participants
|
7 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Last observation: 3
|
52 participants
|
47 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time
Last observation: 4
|
135 participants
|
148 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Confidence in injection device was assessed by participant's response to question, "How confident are you that you can inject yourself properly with the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Baseline- After the training: 0
|
4 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Baseline- After the training: 1
|
3 participants
|
7 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Baseline- After the training: 2
|
12 participants
|
27 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Baseline- After the training: 3
|
70 participants
|
53 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Baseline- After the training: 4
|
117 participants
|
116 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 4: 0
|
6 participants
|
3 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 4: 1
|
0 participants
|
5 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 4: 2
|
7 participants
|
10 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 4: 3
|
47 participants
|
65 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 4: 4
|
135 participants
|
118 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 12: 0
|
9 participants
|
1 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 12: 1
|
1 participants
|
6 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 12: 2
|
4 participants
|
12 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 12: 3
|
43 participants
|
54 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Week 12: 4
|
142 participants
|
123 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Last observation: 0
|
9 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Last observation: 1
|
1 participants
|
6 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Last observation: 2
|
4 participants
|
13 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Last observation: 3
|
47 participants
|
60 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device
Last observation: 4
|
145 participants
|
130 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Confidence in injection device was assessed by participant's response to question, "Are you confident that you have good control over the injection process?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Last observation: 4
|
144 participants
|
135 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Baseline- After the training: 0
|
4 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Baseline- After the training: 1
|
2 participants
|
10 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Baseline- After the training: 2
|
11 participants
|
21 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Baseline- After the training: 3
|
72 participants
|
56 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Baseline- After the training: 4
|
113 participants
|
117 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 4: 0
|
3 participants
|
3 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 4: 1
|
3 participants
|
4 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 4: 2
|
8 participants
|
9 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 4: 3
|
49 participants
|
62 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 4: 4
|
131 participants
|
122 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 12: 0
|
6 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 12: 1
|
3 participants
|
5 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 12: 2
|
6 participants
|
10 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 12: 3
|
43 participants
|
52 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Week 12: 4
|
141 participants
|
127 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Last observation: 0
|
6 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Last observation: 1
|
3 participants
|
5 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Last observation: 2
|
8 participants
|
10 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process
Last observation: 3
|
45 participants
|
59 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Confidence in injection device was assessed by participant's response to question, "How confident are you that you injected yourself successfully?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Last observation: 0
|
5 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Last observation: 2
|
2 participants
|
12 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Baseline- After the training: 0
|
3 participants
|
1 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Baseline- After the training: 1
|
2 participants
|
8 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Baseline- After the training: 2
|
16 participants
|
22 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Baseline- After the training: 3
|
69 participants
|
54 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Baseline- After the training: 4
|
115 participants
|
122 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 4: 0
|
3 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 4: 1
|
3 participants
|
3 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 4: 2
|
5 participants
|
12 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 4: 3
|
60 participants
|
52 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 4: 4
|
124 participants
|
132 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 12: 0
|
5 participants
|
2 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 12: 1
|
3 participants
|
4 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 12: 2
|
1 participants
|
10 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 12: 3
|
55 participants
|
49 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Last observation: 1
|
3 participants
|
4 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Week 12: 4
|
135 participants
|
132 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Last observation: 3
|
58 participants
|
53 participants
|
|
Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection
Last observation: 4
|
138 participants
|
140 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Fear of Device was assessed by participant's response to question, "How nervous do you feel about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Baseline- After the training: 0
|
92 participants
|
80 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Baseline- After the training: 1
|
59 participants
|
54 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Baseline- After the training: 2
|
29 participants
|
39 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Baseline- After the training: 3
|
16 participants
|
24 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Baseline- After the training: 4
|
10 participants
|
10 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 4: 0
|
110 participants
|
103 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 4: 1
|
54 participants
|
51 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 4: 2
|
22 participants
|
27 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 4: 3
|
7 participants
|
15 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 4: 4
|
3 participants
|
5 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 12: 0
|
125 participants
|
111 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 12: 1
|
53 participants
|
46 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 12: 2
|
17 participants
|
19 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 12: 3
|
4 participants
|
15 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Week 12: 4
|
0 participants
|
7 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Last observation: 0
|
131 participants
|
119 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Last observation: 1
|
53 participants
|
48 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Last observation: 2
|
18 participants
|
22 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Last observation: 3
|
4 participants
|
15 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections
Last observation: 4
|
0 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Fear of Device was assessed by participant's response to question, "How nervous do you feel about inserting the needle into your skin?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Baseline- After the training: 0
|
102 participants
|
82 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Baseline- After the training: 1
|
44 participants
|
49 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Baseline- After the training: 2
|
32 participants
|
38 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Baseline- After the training: 3
|
17 participants
|
22 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Baseline- After the training: 4
|
10 participants
|
16 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 4: 0
|
110 participants
|
93 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 4: 1
|
61 participants
|
54 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 4: 2
|
13 participants
|
29 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 4: 3
|
10 participants
|
18 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 4: 4
|
1 participants
|
7 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 12: 0
|
115 participants
|
105 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 12: 1
|
59 participants
|
47 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 12: 2
|
19 participants
|
19 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 12: 3
|
6 participants
|
19 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Week 12: 4
|
0 participants
|
7 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Last observation: 0
|
121 participants
|
112 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Last observation: 1
|
59 participants
|
52 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Last observation: 2
|
20 participants
|
20 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Last observation: 3
|
6 participants
|
20 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin
Last observation: 4
|
0 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Fear of Device was assessed by participant's response to question, "Do you dislike injecting yourself with this device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Baseline- After the training: 0
|
129 participants
|
103 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Baseline- After the training: 1
|
43 participants
|
40 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Baseline- After the training: 2
|
22 participants
|
29 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Baseline- After the training: 3
|
10 participants
|
22 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Baseline- After the training: 4
|
2 participants
|
12 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 4: 0
|
135 participants
|
96 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 4: 1
|
42 participants
|
52 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 4: 2
|
15 participants
|
33 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 4: 3
|
0 participants
|
11 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 4: 4
|
2 participants
|
9 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 12: 0
|
143 participants
|
112 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 12: 1
|
39 participants
|
39 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 12: 2
|
13 participants
|
28 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 12: 3
|
1 participants
|
11 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Week 12: 4
|
3 participants
|
7 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Last observation: 0
|
150 participants
|
119 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Last observation: 1
|
39 participants
|
43 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Last observation: 2
|
13 participants
|
30 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Last observation: 3
|
1 participants
|
12 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device
Last observation: 4
|
3 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Fear of Device was assessed by participant's response to question, "Are you emotionally distressed or anxious about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 12: 0
|
143 participants
|
125 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 12: 1
|
41 participants
|
42 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Baseline- After the training: 0
|
124 participants
|
105 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Baseline- After the training: 1
|
45 participants
|
57 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Baseline- After the training: 2
|
28 participants
|
26 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Baseline- After the training: 3
|
7 participants
|
11 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Baseline- After the training: 4
|
2 participants
|
7 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 4: 0
|
124 participants
|
119 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 4: 1
|
57 participants
|
50 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 4: 2
|
11 participants
|
21 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 4: 3
|
2 participants
|
9 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 4: 4
|
1 participants
|
2 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 12: 2
|
12 participants
|
24 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 12: 3
|
1 participants
|
5 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Week 12: 4
|
1 participants
|
2 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Last observation: 0
|
149 participants
|
134 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Last observation: 1
|
42 participants
|
45 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Last observation: 2
|
13 participants
|
25 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Last observation: 3
|
1 participants
|
5 participants
|
|
Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection
Last observation: 4
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Device characteristics were assessed by participant's response to question, "How much do you like the look of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Baseline- After the training: 0
|
4 participants
|
18 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Baseline- After the training: 1
|
10 participants
|
21 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Baseline- After the training: 2
|
62 participants
|
90 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Baseline- After the training: 3
|
81 participants
|
56 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Baseline- After the training: 4
|
49 participants
|
20 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 4: 0
|
3 participants
|
14 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 4: 1
|
2 participants
|
22 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 4: 2
|
51 participants
|
92 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 4: 3
|
79 participants
|
46 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 4: 4
|
58 participants
|
27 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 12: 0
|
1 participants
|
13 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 12: 1
|
11 participants
|
20 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 12: 2
|
43 participants
|
77 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 12: 3
|
78 participants
|
59 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Week 12: 4
|
66 participants
|
29 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Last observation: 0
|
1 participants
|
14 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Last observation: 1
|
11 participants
|
21 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Last observation: 2
|
46 participants
|
82 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Last observation: 3
|
79 participants
|
62 participants
|
|
Device Characteristics Based on Response to Question Concerning Look of Device
Last observation: 4
|
69 participants
|
32 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Device characteristics were assessed by participant's response to question, "How much do you like the feel of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 12: 3
|
76 participants
|
54 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 12: 4
|
64 participants
|
31 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 12: 1
|
9 participants
|
19 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 12: 2
|
46 participants
|
87 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 4: 4
|
55 participants
|
30 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 12: 0
|
4 participants
|
7 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 4: 3
|
71 participants
|
45 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Baseline- After the training: 0
|
1 participants
|
9 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Baseline- After the training: 1
|
9 participants
|
24 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Baseline- After the training: 2
|
69 participants
|
92 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Baseline- After the training: 3
|
78 participants
|
60 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Baseline- After the training: 4
|
49 participants
|
19 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 4: 0
|
2 participants
|
15 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 4: 1
|
7 participants
|
21 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Week 4: 2
|
58 participants
|
90 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Last observation: 0
|
4 participants
|
7 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Last observation: 1
|
9 participants
|
20 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Last observation: 2
|
49 participants
|
94 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Last observation: 3
|
77 participants
|
58 participants
|
|
Device Characteristics Based on Response to Question Concerning Feel of Device
Last observation: 4
|
67 participants
|
32 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Device characteristics were assessed by participant's response to question, "How much does the device look like something you would feel comfortable to use?" scored on a 5-point Likert scale (0= not at all to 4= very much).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Baseline- After the training: 0
|
7 participants
|
32 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Baseline- After the training: 1
|
11 participants
|
26 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Baseline- After the training: 2
|
68 participants
|
76 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Baseline- After the training: 3
|
67 participants
|
55 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Baseline- After the training: 4
|
53 participants
|
16 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 4: 0
|
6 participants
|
28 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 4: 1
|
8 participants
|
22 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 4: 2
|
51 participants
|
74 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 4: 3
|
69 participants
|
45 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 4: 4
|
59 participants
|
32 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 12: 0
|
7 participants
|
27 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 12: 1
|
15 participants
|
21 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 12: 2
|
47 participants
|
62 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 12: 3
|
65 participants
|
54 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Week 12: 4
|
65 participants
|
34 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Last observation: 0
|
7 participants
|
27 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Last observation: 1
|
16 participants
|
22 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Last observation: 2
|
47 participants
|
68 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Last observation: 3
|
67 participants
|
58 participants
|
|
Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks
Last observation: 4
|
69 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
Side effects related to administration were assessed by participant's response to question, "Do you experience pain during or immediately after the injection?" scored on a 5-point Likert scale (0= none to 4= severe).
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Last observation: 1
|
70 participants
|
72 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Baseline- After the first injection: 0
|
98 participants
|
109 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Baseline- After the first injection: 1
|
65 participants
|
54 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Baseline- After the first injection: 2
|
24 participants
|
31 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Baseline- After the first injection: 3
|
9 participants
|
8 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Baseline- After the first injection: 4
|
3 participants
|
0 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 4: 0
|
77 participants
|
88 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 4: 1
|
60 participants
|
60 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 4: 2
|
33 participants
|
31 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 4: 3
|
22 participants
|
21 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 4: 4
|
3 participants
|
1 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 12: 0
|
76 participants
|
84 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 12: 1
|
68 participants
|
70 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 12: 2
|
30 participants
|
28 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 12: 3
|
21 participants
|
15 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Week 12: 4
|
4 participants
|
1 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Last observation: 0
|
79 participants
|
90 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Last observation: 2
|
31 participants
|
32 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Last observation: 3
|
22 participants
|
16 participants
|
|
Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection
Last observation: 4
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.
SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
Baseline- After the training
|
11.0 units on a scale
Standard Deviation 3.5
|
11.2 units on a scale
Standard Deviation 3.6
|
|
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
Week 4
|
9.9 units on a scale
Standard Deviation 3.3
|
10.0 units on a scale
Standard Deviation 3.5
|
|
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
Week 12
|
10.1 units on a scale
Standard Deviation 3.2
|
10.1 units on a scale
Standard Deviation 3.3
|
|
Short Form State-Trait Anxiety Inventory (SF STAI) Global Score
Last observation
|
10.1 units on a scale
Standard Deviation 3.3
|
10.1 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Age on Participant Perception
Very satisfied (n=119, 92)
|
47.9 years
Standard Deviation 12.6
|
49.1 years
Standard Deviation 12.7
|
|
Influence of Age on Participant Perception
Satisfied (n= 56, 65)
|
42.8 years
Standard Deviation 12.9
|
43.9 years
Standard Deviation 13.3
|
|
Influence of Age on Participant Perception
Less satisfied (n= 20, 41)
|
42.7 years
Standard Deviation 15.4
|
42.5 years
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Gender on Participant Perception
Very satisfied: Male (n=119, 92)
|
77 participants
|
67 participants
|
|
Influence of Gender on Participant Perception
Very satisfied: Female (n=119, 92)
|
42 participants
|
25 participants
|
|
Influence of Gender on Participant Perception
Satisfied: Male (n= 56, 65)
|
37 participants
|
45 participants
|
|
Influence of Gender on Participant Perception
Satisfied: Female (n= 56, 65)
|
19 participants
|
20 participants
|
|
Influence of Gender on Participant Perception
Less satisfied: Male (n= 20, 41)
|
13 participants
|
26 participants
|
|
Influence of Gender on Participant Perception
Less satisfied: Female (n= 20, 41)
|
7 participants
|
15 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Socio-educational Status on Participant Perception
Less satisfied: Reading/Writing level (n= 20, 41)
|
10 participants
|
16 participants
|
|
Influence of Socio-educational Status on Participant Perception
Less satisfied: High school level (n= 20, 41)
|
7 participants
|
16 participants
|
|
Influence of Socio-educational Status on Participant Perception
Very satisfied: High school level (n=119, 92)
|
56 participants
|
43 participants
|
|
Influence of Socio-educational Status on Participant Perception
Very satisfied: University level (n=119, 92)
|
22 participants
|
17 participants
|
|
Influence of Socio-educational Status on Participant Perception
Satisfied: Reading/Writing level (n= 56, 65)
|
12 participants
|
19 participants
|
|
Influence of Socio-educational Status on Participant Perception
Satisfied: High school level (n= 56, 65)
|
34 participants
|
32 participants
|
|
Influence of Socio-educational Status on Participant Perception
Satisfied: University level (n= 56, 65)
|
10 participants
|
14 participants
|
|
Influence of Socio-educational Status on Participant Perception
Less satisfied: University level (n= 20, 41)
|
3 participants
|
9 participants
|
|
Influence of Socio-educational Status on Participant Perception
Very satisfied: Reading/Writing level (n=119, 92)
|
41 participants
|
32 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Satisfied: HAD-A (n= 56, 65)
|
7.0 units on a scale
Full Range 4.3 • Interval 2.0 to 20.0
|
7.0 units on a scale
Full Range 4.1 • Interval 0.0 to 16.0
|
|
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Less satisfied: HAD-A (n= 20, 41)
|
9.2 units on a scale
Full Range 3.5 • Interval 3.0 to 16.0
|
10.0 units on a scale
Full Range 4.2 • Interval 2.0 to 17.0
|
|
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Very satisfied: HAD-A (n=119, 92)
|
7.0 units on a scale
Full Range 3.8 • Interval 0.0 to 17.0
|
6.0 units on a scale
Full Range 4.6 • Interval 0.0 to 19.0
|
|
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Very satisfied: HAD-D (n=119, 92)
|
5.0 units on a scale
Full Range 3.7 • Interval 0.0 to 18.0
|
4.0 units on a scale
Full Range 3.9 • Interval 0.0 to 16.0
|
|
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Satisfied: HAD-D (n= 56, 65)
|
5.5 units on a scale
Full Range 4.0 • Interval 0.0 to 17.0
|
5.0 units on a scale
Full Range 3.3 • Interval 0.0 to 14.0
|
|
Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception
Less satisfied: HAD-D (n= 20, 41)
|
6.5 units on a scale
Full Range 4.2 • Interval 0.0 to 14.0
|
8.0 units on a scale
Full Range 4.0 • Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception
Satisfied (n= 56, 63)
|
53.0 units on a scale
Standard Deviation 11.7
|
57.5 units on a scale
Standard Deviation 11.8
|
|
Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception
Very satisfied (n=116, 91)
|
58.0 units on a scale
Standard Deviation 13.8
|
60.5 units on a scale
Standard Deviation 14.0
|
|
Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception
Less satisfied (n= 20, 40)
|
60.0 units on a scale
Standard Deviation 13.9
|
52.4 units on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Prior Injection Experience on Participant Perception
Very satisfied: with experience (n=119, 92)
|
47 participants
|
43 participants
|
|
Influence of Prior Injection Experience on Participant Perception
Very satisfied: without experience (n=119, 92)
|
72 participants
|
49 participants
|
|
Influence of Prior Injection Experience on Participant Perception
Satisfied: without experience (n= 56, 65)
|
36 participants
|
37 participants
|
|
Influence of Prior Injection Experience on Participant Perception
Less satisfied: with experience (n= 20, 41)
|
9 participants
|
16 participants
|
|
Influence of Prior Injection Experience on Participant Perception
Satisfied: with experience (n= 56, 65)
|
20 participants
|
28 participants
|
|
Influence of Prior Injection Experience on Participant Perception
Less satisfied: without experience (n= 20, 41)
|
11 participants
|
25 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Prior Self-injection Experience on Participant Perception
Very satisfied: with experience (n=119, 92)
|
23 participants
|
33 participants
|
|
Influence of Prior Self-injection Experience on Participant Perception
Very satisfied: without experience (n=119, 92)
|
96 participants
|
59 participants
|
|
Influence of Prior Self-injection Experience on Participant Perception
Satisfied: with experience (n= 56, 65)
|
13 participants
|
16 participants
|
|
Influence of Prior Self-injection Experience on Participant Perception
Satisfied: without experience (n= 56, 65)
|
43 participants
|
49 participants
|
|
Influence of Prior Self-injection Experience on Participant Perception
Less satisfied: with experience (n= 20, 41)
|
5 participants
|
9 participants
|
|
Influence of Prior Self-injection Experience on Participant Perception
Less satisfied: without experience (n= 20, 41)
|
15 participants
|
32 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Duration of Psoriasis on Participant Perception
Very satisfied (n=119, 92)
|
23.3 years
Standard Deviation 13.3 • Interval 1.0 to 61.0
|
22.9 years
Standard Deviation 12.1 • Interval 1.0 to 63.0
|
|
Influence of Duration of Psoriasis on Participant Perception
Satisfied (n= 56, 65)
|
17.8 years
Standard Deviation 10.0 • Interval 3.0 to 41.0
|
20.6 years
Standard Deviation 10.8 • Interval 2.0 to 53.0
|
|
Influence of Duration of Psoriasis on Participant Perception
Less satisfied (n= 20, 41)
|
16.1 years
Standard Deviation 7.4 • Interval 4.0 to 30.0
|
17.1 years
Standard Deviation 9.8 • Interval 3.0 to 46.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception
Very satisfied (n=119, 92)
|
3.0 units on a scale
Full Range 0.8 • Interval 1.0 to 5.0
|
3.0 units on a scale
Full Range 0.6 • Interval 2.0 to 5.0
|
|
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception
Satisfied (n= 56, 65)
|
3.0 units on a scale
Full Range 0.7 • Interval 2.0 to 5.0
|
3.0 units on a scale
Full Range 0.8 • Interval 1.0 to 5.0
|
|
Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception
Less satisfied (n= 20, 40)
|
3.0 units on a scale
Full Range 0.7 • Interval 2.0 to 5.0
|
3.0 units on a scale
Full Range 0.8 • Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Psoriasis Area Severity Index (PASI) on Participant Perception
Satisfied (n= 56, 65)
|
18.6 units on a scale
Standard Deviation 9.8
|
17.5 units on a scale
Standard Deviation 7.9
|
|
Influence of Psoriasis Area Severity Index (PASI) on Participant Perception
Less satisfied (n= 20, 39)
|
17.1 units on a scale
Standard Deviation 8.0
|
15.9 units on a scale
Standard Deviation 10.2
|
|
Influence of Psoriasis Area Severity Index (PASI) on Participant Perception
Very satisfied (n=118, 92)
|
17.2 units on a scale
Standard Deviation 7.5
|
17.9 units on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Participant's Assessment of General Health on Participant Perception
Very satisfied (n=117, 90)
|
64.9 mm
Standard Deviation 23.7
|
63.8 mm
Standard Deviation 27.9
|
|
Influence of Participant's Assessment of General Health on Participant Perception
Satisfied (n= 55, 65)
|
59.3 mm
Standard Deviation 25.3
|
70.7 mm
Standard Deviation 21.5
|
|
Influence of Participant's Assessment of General Health on Participant Perception
Less satisfied (n= 20, 40)
|
48.8 mm
Standard Deviation 31.2
|
60.5 mm
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Participant's Global Assessment of Psoriasis on Participant Perception
Very satisfied (n=116, 90)
|
73.5 mm
Standard Deviation 17.7
|
73.4 mm
Standard Deviation 18.0
|
|
Influence of Participant's Global Assessment of Psoriasis on Participant Perception
Satisfied (n= 55, 65)
|
69.9 mm
Standard Deviation 19.1
|
73.3 mm
Standard Deviation 19.8
|
|
Influence of Participant's Global Assessment of Psoriasis on Participant Perception
Less satisfied (n= 20, 39)
|
72.6 mm
Standard Deviation 21.2
|
70.8 mm
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Dermatology Life Quality Index (DLQI) on Participant Perception
Satisfied (n= 54, 63)
|
12.4 units on a scale
Standard Deviation 6.4
|
12.8 units on a scale
Standard Deviation 6.0
|
|
Influence of Dermatology Life Quality Index (DLQI) on Participant Perception
Very satisfied (n=116, 90)
|
13.4 units on a scale
Standard Deviation 6.8
|
13.1 units on a scale
Standard Deviation 7.1
|
|
Influence of Dermatology Life Quality Index (DLQI) on Participant Perception
Less satisfied (n= 18, 41)
|
14.6 units on a scale
Standard Deviation 6.9
|
13.1 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Co-morbidities on Participant Perception
Very satisfied: Tobacco usage- Yes (n=119, 92)
|
49 participants
|
31 participants
|
|
Influence of Co-morbidities on Participant Perception
Satisfied: Tobacco usage- Yes (n= 56, 65)
|
20 participants
|
25 participants
|
|
Influence of Co-morbidities on Participant Perception
Satisfied: Alcohol usage- Yes (n= 56, 65)
|
20 participants
|
29 participants
|
|
Influence of Co-morbidities on Participant Perception
Satisfied: Alcohol usage- No (n= 56, 65)
|
36 participants
|
36 participants
|
|
Influence of Co-morbidities on Participant Perception
Less satisfied: Tobacco usage- Yes (n= 20, 41)
|
8 participants
|
19 participants
|
|
Influence of Co-morbidities on Participant Perception
Less satisfied: Alcohol usage- Yes (n= 20, 41)
|
6 participants
|
11 participants
|
|
Influence of Co-morbidities on Participant Perception
Very satisfied: Tobacco usage- No (n=119, 92)
|
70 participants
|
61 participants
|
|
Influence of Co-morbidities on Participant Perception
Very satisfied: Alcohol usage- Yes (n=119, 92)
|
59 participants
|
38 participants
|
|
Influence of Co-morbidities on Participant Perception
Very satisfied: Alcohol usage- No (n=119, 92)
|
60 participants
|
54 participants
|
|
Influence of Co-morbidities on Participant Perception
Satisfied: Tobacco usage- No (n= 56, 65)
|
36 participants
|
40 participants
|
|
Influence of Co-morbidities on Participant Perception
Less satisfied: Tobacco usage- No (n= 20, 41)
|
12 participants
|
22 participants
|
|
Influence of Co-morbidities on Participant Perception
Less satisfied: Alcohol usage- No (n= 20, 41)
|
14 participants
|
30 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.
Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.
Outcome measures
| Measure |
Etanercept 50 mg Auto-injector
n=206 Participants
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 Participants
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Less satisfied: Prior medication- No (n= 20, 41)
|
0 participants
|
0 participants
|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Very satisfied: Prior medication- No (n=119, 92)
|
0 participants
|
0 participants
|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Satisfied: Prior medication- No (n= 56, 65)
|
0 participants
|
1 participants
|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Less satisfied: Prior medication- Yes (n= 20, 41)
|
20 participants
|
41 participants
|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Very satisfied: Prior medication- Yes (n=119, 92)
|
119 participants
|
92 participants
|
|
Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception
Satisfied: Prior medication- Yes (n= 56, 65)
|
56 participants
|
64 participants
|
Adverse Events
Etanercept 50 mg Auto-injector
Serious events: 6 serious events
Other events: 94 other events
Deaths: 0 deaths
Etanercept 50 mg Prefilled Syringe
Serious events: 5 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept 50 mg Auto-injector
n=207 participants at risk
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 participants at risk
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.48%
1/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.48%
1/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bursitis infective
|
0.48%
1/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.48%
1/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Retinal operation
|
0.48%
1/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.48%
1/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.48%
1/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Urinary calculus removal
|
0.00%
0/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.47%
1/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.47%
1/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.47%
1/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Prostatic operation
|
0.00%
0/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.47%
1/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.47%
1/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Etanercept 50 mg Auto-injector
n=207 participants at risk
Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
|
Etanercept 50 mg Prefilled Syringe
n=211 participants at risk
Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
|
|---|---|---|
|
General disorders
Injection site erythema
|
4.8%
10/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.1%
17/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site haematoma
|
4.8%
10/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.4%
3/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site irritation
|
2.9%
6/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
9/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pain
|
4.8%
10/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.7%
10/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pruritis
|
1.4%
3/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
5/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
8.7%
18/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.1%
17/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
2.4%
5/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
9/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
11.6%
24/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.8%
27/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
7/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
4/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
5/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.95%
2/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
6.3%
13/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
15/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
4/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
5/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
4/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
5/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.3%
13/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
6/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.4%
5/207
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
9/211
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER