Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 11, 2014
First Posted Date July 16, 2014
Results First Submitted Date April 11, 2017
Results First Posted Date June 28, 2017
Last Update Posted Date June 28, 2017
Study Start Date November 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2017)
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 [ Time Frame: Baseline (Day 1), Week 24 ]
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.
Original Primary Outcome Measures
 (submitted: July 14, 2014)
  • Change of Psoriasis Assessment And Severity Index from baseline to 12 weeks and 24 weeks [ Time Frame: baseline, 12 weeks, 24 weeks ]
    Commonly used measurement of psoriasis severity by measuring induration, desquamation and erythema of the skin combined with body surface are affected
  • Smoking Habit Questionnaire [ Time Frame: baseline ]
    Short questionnaire aboout current and past smoking habits of the patients
Change History Complete list of historical versions of study NCT02192164 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 11, 2017)
  • Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    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.
  • Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 [ Time Frame: Week 12, 24 ]
    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.
  • Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
    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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2017)
  • Smoking Habit Questionnaire: Smoking Status of Participants [ Time Frame: Day 1 ]
    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.
  • Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted [ Time Frame: Day 1 ]
    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.
  • Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants [ Time Frame: Day 1 ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis
Official Title Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Brief Summary Pilot observational study to describe the relationship between the smoking status of a psoriatic individual and the success of etanercept therapy in psoriasis treatment
Detailed Description non-interventional study There is no sampling
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population etanercept treated plaque psoriasis patients
Condition Plaque Psoriasis
Intervention Behavioral: smoking questionnaire
patients fill in a smoking questionnaire about their smoking habits
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2016)
126
Original Estimated Enrollment
 (submitted: July 14, 2014)
128
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator Patients who are scheduled by their dermatologist to initiate treatment with Etanercept

Exclusion Criteria:

Previous or current treatment with antipsoriatic biologic drugs, such as etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab Chronic or acute infections requiring intravenous or oral anti-infectives within 14 days prior to the Baseline visit

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT02192164
Other Study ID Numbers B1801365
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2017