Trial Outcomes & Findings for Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept (NCT NCT00992394)
NCT ID: NCT00992394
Last Updated: 2016-01-08
Results Overview
PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. 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. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks\*7days + 1.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
174 participants
Primary outcome timeframe
Week 52
Results posted on
2016-01-08
Participant Flow
This multicenter open label, randomized study screened 209 participants in 44 sites.
Psoriasis participants who had responded to initial treatment with ETN were enrolled in this study. Participants were randomized to 2 groups: Stop arm, stopped etanercept (ETN) treatment on study entry and could be retreated with ETN 50 mg once weekly. Maintenance arm, continued ETN treatment at 25 mg once weekly, but could increase dose to 50 mg.
Participant milestones
| Measure |
Stop Arm
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
86
|
|
Overall Study
Safety Population
|
87
|
84
|
|
Overall Study
mITT Population
|
86
|
84
|
|
Overall Study
COMPLETED
|
64
|
72
|
|
Overall Study
NOT COMPLETED
|
24
|
14
|
Reasons for withdrawal
| Measure |
Stop Arm
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
3
|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Other event
|
1
|
0
|
Baseline Characteristics
Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept
Baseline characteristics by cohort
| Measure |
Stop Arm
n=87 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.39 Years
STANDARD_DEVIATION 14.10 • n=5 Participants
|
47.71 Years
STANDARD_DEVIATION 13.77 • n=7 Participants
|
49.08 Years
STANDARD_DEVIATION 13.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. Last Observation Carried Forward (LOCF).
PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. 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. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks\*7days + 1.
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52
|
1.64 Units on a scale
Standard Deviation 0.75
|
1.33 Units on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Week 52Population: The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
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. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52
|
4.07 Units on a scale
Standard Deviation 4.21
|
2.96 Units on a scale
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
66 Number of participants
|
67 Number of participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1
|
15 Number of participants
|
5 Number of participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1
|
31 Number of participants
|
12 Number of participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2
|
5 Number of participants
|
1 Number of participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of re-treatment, Cycle 2
|
10 Number of participants
|
2 Number of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
60 Number of Participants
|
59 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
12 Number of Participants
|
4 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, satisfied
|
26 Number of Participants
|
11 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle, 2, Satisfied
|
5 Number of Participants
|
1 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
8 Number of Participants
|
2 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
62 Number of Participants
|
59 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
14 Number of Participants
|
4 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
27 Number of Participants
|
10 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
4 Number of Participants
|
1 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
8 Number of Participants
|
2 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
61 Number of Participants
|
54 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
17 Number of Participants
|
5 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
30 Number of Participants
|
9 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
6 Number of Participants
|
2 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
10 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
45 Number of Participants
|
37 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
17 Number of Participants
|
11 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
22 Number of Participants
|
10 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
7 Number of Participants
|
2 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
10 Number of Participants
|
2 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
23 Number of Participants
|
8 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
4 Number of Participants
|
1 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
51 Number of Participants
|
39 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
14 Number of Participants
|
6 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
10 Number of Participants
|
2 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
47 Number of Participants
|
44 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
13 Number of Participants
|
7 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
24 Number of Participants
|
8 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
5 Number of Participants
|
1 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
9 Number of Participants
|
1 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
33 Number of Participants
|
23 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
7 Number of Participants
|
7 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
14 Number of Participants
|
7 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
5 Number of Participants
|
2 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
7 Number of Participants
|
1 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
35 Number of Participants
|
8 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
8 Number of Participants
|
1 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
64 Number of Participants
|
58 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
17 Number of Participants
|
6 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
10 Number of Participants
|
2 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
43 Number of Participants
|
36 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
13 Number of Participants
|
6 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
17 Number of Participants
|
5 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
5 Number of Participants
|
2 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
5 Number of Participants
|
1 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
39 Number of Participants
|
31 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
15 Number of Participants
|
5 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
17 Number of Participants
|
3 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
6 Number of Participants
|
1 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
6 Number of Participants
|
1 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
44 Number of Participants
|
43 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
13 Number of Participants
|
7 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
20 Number of Participants
|
6 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
7 Number of Participants
|
2 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
9 Number of Participants
|
2 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
7 Number of Participants
|
2 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
50 Number of Participants
|
48 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
20 Number of Participants
|
7 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
28 Number of Participants
|
9 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
8 Number of Participants
|
1 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
23 Number of Participants
|
9 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
29 Number of Participants
|
8 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
8 Number of Participants
|
0 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
9 Number of Participants
|
0 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
56 Number of Participants
|
45 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
84 Number of Participants
|
79 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
30 Number of Participants
|
13 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
39 Number of Participants
|
17 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
7 Number of Participants
|
4 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
10 Number of Participants
|
4 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment
Baseline, Subjects Satisfied
|
82 Number of Participants
|
78 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 1, Satisfied
|
34 Number of Participants
|
16 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 1, Satisfied
|
41 Number of Participants
|
18 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment
Prior to Re-treatment, Cycle 2, Satisfied
|
11 Number of Participants
|
4 Number of Participants
|
|
Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment
End of Re-treatment, Cycle 2, Satisfied
|
10 Number of Participants
|
4 Number of Participants
|
SECONDARY outcome
Timeframe: Week 52Population: The modified intent-to-treat (mITT) population will be the primary efficacy population and will correspond to all randomized subjects who have a baseline PGA and at least one postbaseline PGA.
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).
Outcome measures
| Measure |
Stop Arm
n=86 Participants
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 Participants
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Physician Global Assessment (PGA) of Disease Activity at Week 52
|
1.8 Units on a scale
Standard Deviation 1.02
|
1.4 Units on a scale
Standard Deviation 1.00
|
Adverse Events
Stop Arm
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Maintenance Arm
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stop Arm
n=87 participants at risk
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 participants at risk
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.2%
1/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.1%
1/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.2%
1/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.00%
0/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.2%
1/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.2%
1/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Furuncle
|
0.00%
0/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.2%
1/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.2%
1/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
1.1%
1/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.2%
1/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Viith Nerve Paralysis
|
1.1%
1/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
1.1%
1/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.1%
1/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Polyps
|
1.1%
1/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Arterial Stenosis
|
1.1%
1/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Stop Arm
n=87 participants at risk
Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
|
Maintenance Arm
n=84 participants at risk
Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
5.7%
5/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.7%
9/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
10/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
26.2%
22/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
5.7%
5/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.6%
3/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.2%
8/87 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.1%
6/84 • Post baseline period
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant 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