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

NCT02192164 | Completed Results

• 1 other identifier: B1801365
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 8

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

Conditions

Plaque Psoriasis

Keywords

plaque psoriasis; smoking; etanercept

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at 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.

  Baseline (Day 1), Week 24

Secondary Outcomes (3)

• Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12

  Baseline, Week 12

• Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24

  Week 12, 24

• Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24

  Baseline, Week 12, 24

Other Outcomes (3)

• Smoking Habit Questionnaire: Smoking Status of Participants

  Day 1

• Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted

  Day 1

• Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants

  Day 1

Interventions

smoking questionnaire BEHAVIORAL

patients fill in a smoking questionnaire about their smoking habits

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

etanercept treated plaque psoriasis patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Semmelweis University

Budapest, H-1085, Hungary

Location

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, H-7400, Hungary

Location

Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza

Kecskemét, 6000, Hungary

Location

Semmelweis Korhaz-Rendelointezet

Miskolc, 3529, Hungary

Location

Pecsi Tudomanyegyetem, Br-, Nemikortani es Onkodermatologiai Klinika

Pécs, H-7624, Hungary

Location

Medical University of Szeged

Szeged, 6720, Hungary

Location

Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly

Szombathely, 9700, Hungary

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Prioritization of outcome measures as primary and secondary was based on the study team's discretion.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: July 16, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-04

Locations

HU (8)