| Primary | Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population | Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0008.9± 1.9
- OG0017.6± 2.6
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis. | ANOVA | | <0.001 | Statistical testing, one-sided, was done at 2.5% significance level. | Mean Difference (Final Values) | 1.32 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | 0.87 | 1.77 | | | | Yes | Non-Inferiority or Equivalence | The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1. |
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| Primary | Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population | Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Percentage of Participants Satisfied With Injection Device | Participant satisfaction was assessed by asking the question "Are you satisfied with your injection device? and using a dichotomous response: Yes or No. | 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. | Posted | | Number | | percentage of participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Age on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Gender on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Socio-educational Status on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device | Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant's global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Co-morbidities on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Prior Injection Experience on Participant Satisfaction With Injection Device | Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device | Ease of use of injection device was assessed by participant's response to question, "How easy was it to perform an injection with this device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult). | 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. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device | Ease of use of injection device was assessed by participant's response to question, "How easy was it to use the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult). | 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. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device | Ease of use of injection device was assessed by participant's response to question, "How easy was it to dispose of the device?" scored on a 5-point Likert scale (0= very easy to 4= very difficult). | 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. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete | Ease of use of injection device was assessed by participant's response to question, "How easy is it to know when the injection is completed?" scored on a 5-point Likert scale (0= very easy to 4= very difficult). | 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. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting | Ease of use of injection device was assessed by participant's response to question, "How easy is it to hold the device whilst injecting?" scored on a 5-point Likert scale (0= very easy to 4= very difficult) | 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. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting | Ease of use of injection device was assessed by participant's response to question, "Did you feel any hand discomfort whilst using the device?" scored on a 5-point Likert scale (0= none to 4= extreme). | 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. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal) | Ease of Use of Injection Device was assessed by participant's response to question, "How long does it take to perform the injection, including any preparation and disposal?" where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'. | 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. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity | Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity | Convenience of injection device was assessed by participant's response to question, "Do you think injecting etanercept will interfere with your usual daily activities?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling | Convenience of injection device was assessed by participant's response to question, "How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections | Confidence in injection device was assessed by participant's response to question, "How confident are you in your management of your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time | Confidence in injection device was assessed by participant's response to question, "How confident are you that you inject the right amount of medicine every time?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device | Confidence in injection device was assessed by participant's response to question, "How confident are you that you can inject yourself properly with the device?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process | Confidence in injection device was assessed by participant's response to question, "Are you confident that you have good control over the injection process?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection | Confidence in injection device was assessed by participant's response to question, "How confident are you that you injected yourself successfully?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections | Fear of Device was assessed by participant's response to question, "How nervous do you feel about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin | Fear of Device was assessed by participant's response to question, "How nervous do you feel about inserting the needle into your skin?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device | Fear of Device was assessed by participant's response to question, "Do you dislike injecting yourself with this device?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection | Fear of Device was assessed by participant's response to question, "Are you emotionally distressed or anxious about your injections?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Device Characteristics Based on Response to Question Concerning Look of Device | Device characteristics were assessed by participant's response to question, "How much do you like the look of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Device Characteristics Based on Response to Question Concerning Feel of Device | Device characteristics were assessed by participant's response to question, "How much do you like the feel of the device?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks | Device characteristics were assessed by participant's response to question, "How much does the device look like something you would feel comfortable to use?" scored on a 5-point Likert scale (0= not at all to 4= very much). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection | Side effects related to administration were assessed by participant's response to question, "Do you experience pain during or immediately after the injection?" scored on a 5-point Likert scale (0= none to 4= severe). | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Number | | participants | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Short Form State-Trait Anxiety Inventory (SF STAI) Global Score | SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety. | mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Age on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants. | 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. | Posted | | Mean | Standard Deviation | years | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Gender on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants. | 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. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Socio-educational Status on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants. | 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. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception | Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants. | 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. | Posted | | Median | Full Range | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Prior Injection Experience on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants. | 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. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Prior Self-injection Experience on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants. | 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. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Duration of Psoriasis on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants. | 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. | Posted | | Mean | Standard Deviation | years | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants. | 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. | Posted | | Median | Full Range | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Psoriasis Area Severity Index (PASI) on Participant Perception | Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Participant's Assessment of General Health on Participant Perception | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant's assessment of general health score was determined for each cluster of participants. | 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. | Posted | | Mean | Standard Deviation | mm | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Participant's Global Assessment of Psoriasis on Participant Perception | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant's assessment of psoriasis score was determined for each cluster of participants. | 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. | Posted | | Mean | Standard Deviation | mm | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Dermatology Life Quality Index (DLQI) on Participant Perception | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Co-morbidities on Participant Perception | Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants. | 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. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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| Secondary | Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception | Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants. | 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. | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Auto-injector | Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks. | | OG001 | Etanercept 50 mg Prefilled Syringe | Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks. |
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