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Trial record 54 of 1709 for:    psoriasis

Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis

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ClinicalTrials.gov Identifier: NCT02192164
Recruitment Status : Completed
First Posted : July 16, 2014
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Plaque Psoriasis
Intervention Behavioral: smoking questionnaire
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept
Hide Arm/Group Description Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician’s discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Period Title: Overall Study
Started 126
Etanercept Treated Population 112
Completed 112
Not Completed 14
Reason Not Completed
Other             8
Withdrawal by Subject             1
Physician Decision             4
Did not meet the exclusion criteria             1
Arm/Group Title Etanercept
Hide Arm/Group Description Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician’s discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Baseline Participants 112
Hide Baseline Analysis Population Description
All treated participants with available post-baseline documentation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants
47.37  (15.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants
Female
45
  40.2%
Male
67
  59.8%
1.Primary Outcome
Title Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
Hide Description PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time Frame Baseline (Day 1), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available post-baseline documentation.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Participants Analyzed 86 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.02093  (6.298742) 20.40769  (4.991266)
Change at Week 24 -18.40349  (6.606279) -15.64615  (8.649496)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Non Smokers, Etanercept: Smokers
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.757334
Confidence Interval (2-Sided) 95%
-5.916307 to 0.401638
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.594019
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
Hide Description PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available post-baseline documentation.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Participants Analyzed 86 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
-18.18837  (6.236787) -17.27692  (6.819402)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Non Smokers, Etanercept: Smokers
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.911449
Confidence Interval (2-Sided) 95%
-3.73847 to 1.915572
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.426517
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
Hide Description PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
Time Frame Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available post-baseline documentation.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Participants Analyzed 86 26
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 82.56 76.92
Week 24 86.05 69.23
4.Secondary Outcome
Title Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24
Hide Description Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Time Frame Baseline, Week 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available post-baseline documentation.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Participants Analyzed 86 26
Mean (Standard Deviation)
Unit of Measure: percent change
Week 12 0.139  (0.163) 0.168  (0.218)
Week 24 0.120  (0.196) 0.257  (0.358)
5.Other Pre-specified Outcome
Title Smoking Habit Questionnaire: Smoking Status of Participants
Hide Description Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available post-baseline documentation.
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description:
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Participants Analyzed 86 26
Measure Type: Number
Unit of Measure: participants
Never smoke 51 0
Current smokers 0 26
Former smokers 35 0
6.Other Pre-specified Outcome
Title Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted
Hide Description Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available post-baseline documentation. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for each arm. Data for this outcome measure was planned to be analyzed in smokers and former smokers.
Arm/Group Title Etanercept: Former Smoker + Smoker
Hide Arm/Group Description:
Participants who were smokers during the study and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Participants Analyzed 61
Mean (Standard Error)
Unit of Measure: years
Age when participants started smoking (n =61) 18.55738  (0.7493256)
Age when participants quitted smoking (n =35) 21.25714  (2.165948)
7.Other Pre-specified Outcome
Title Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants
Hide Description Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with available post-baseline documentation. Here, ‘N’ signifies those participants who were evaluable for this measure. Data for this outcome measure was planned to be analyzed in smokers and former smokers.
Arm/Group Title Etanercept: Former Smoker + Smoker
Hide Arm/Group Description:
Participants who were smokers during the study and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
Overall Number of Participants Analyzed 61
Mean (Standard Error)
Unit of Measure: years
21  (1.604808)
Time Frame [Not Specified]
Adverse Event Reporting Description Due to non-interventional nature of the study, safety data was not planned to be collected.
 
Arm/Group Title Etanercept: Non Smokers Etanercept: Smokers
Hide Arm/Group Description Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician’s discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection.
All-Cause Mortality
Etanercept: Non Smokers Etanercept: Smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept: Non Smokers Etanercept: Smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept: Non Smokers Etanercept: Smokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Prioritization of outcome measures as primary and secondary was based on the study team’s discretion.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02192164     History of Changes
Other Study ID Numbers: B1801365
First Submitted: April 11, 2014
First Posted: July 16, 2014
Results First Submitted: April 11, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017