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Chronic Plaque PsoriasisNCT02570750

The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

An observational study of Chronic Plaque Psoriasis, run by Pfizer at 30 sites in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Plaque Psoriasis
What is being tested?
QUESTIONNAIRE ON SMOKING HABITS
How many people
183 participants
Where
30 sitesRomania
Study dates
7 May 2015to 5 Dec 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept

Who may be able to join

  • Adult patients aged ≥18 years at the time of screening
  • 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 prescribed independently by the investigator as per local clinical practice guideline
  • Stable plaque psoriasis for at least 2 months prior to Baseline
  • Diagnosis of severe psoriasis defined as PASI > 10
  • Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC)
  • Smokers with smoking >10 cigarettes daily for smokers group (Group 1) or non-smokers for non-smoking group (Group 2)
  • Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study

Who cannot join

  • Previous or current treatment with antipsoriatic biologic drugs, such as Etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab.
  • Exclusion Criteria according to the Enbrel® SmPC, with particular attention to: hypersensitivity to the active substance (etanercept) or to any of the excipients; sepsis or risk of sepsis, active infections, including chronic or localised infections.
  • Positive pregnancy test, breast feeding or considering becoming pregnant during the study
  • Clinically significant drug or alcohol abuse

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Romania30 sites
  • Stoica Dan Marius Dermatology Office Arad

    Arad, 310112

  • Emergency Hospital Bacau / Dermatology Department

    Bacau, 600114

  • Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen

    Baia Mare, Maramureş, 430341

  • County Emergency Hospital "Mavromati" Botosani / Dermatology Department

    Botoșani, 710211

  • County Emergency Hospital Brasov / Dermatology Department

    Brasov, 500326

  • Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department

    Bucharest, 010825

  • Elias Emergency University Hospital Bucharest / Dermatology Department

    Bucharest, 011461

  • Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department

    Bucharest, 011464

  • Clinical Hospital Colentina Bucharest / Dermatology Department

    Bucharest, 020125

  • Hospital "Dr. Victor Babes" Bucharest / Dermatology Department

    Bucharest, 030303

  • SCBI Ambulatory Cluj-Napoca / Dermatology Department

    Cluj-Napoca, Cluj, 400001

  • Dr. Remus Orasan Medical Office

    Cluj-Napoca, Cluj, 400105

  • Dr Ianosi Medical Center Craiova / Dermatology Department

    Craiova, Dolj, 200061

  • Emergency County Hospital Craiova / Dermatology Department

    Craiova, Dolj, 200642

  • Helios Medica Ambulatory Craiova / Dermatology Department

    Craiova, Dolj, 200642

  • County Emergency Hospital Drobeta Turnu Severin / Dermatology Department

    Drobeta-Turnu Severin, Mehedinți County, 220097

  • County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department

    Focşani, Vrancea, 620034

  • County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department

    Iași, 700106

  • Railways Hospital Iasi / Dermatology Department

    Iași, 700506

  • Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department

    Piteşti, Argeş, 110121

  • County Emergency Hospital Pitesti / Dermatology Department

    Piteşti, Argeş, 110283

  • County Emergency Hospital Ploiesti / Dermatology Department

    Ploieşti, Prahova, 100184

  • County Emergency Hospital Ploiesti / Dermatology Department

    Ploieşti, Prahova, 100576

  • Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin

    Reghin, Mureș County, 545300

  • Sighisoara Municipal Hospital / Dermatology Department

    Sighișoara, Mureș County, 545400

  • Bucovina Medical Office Suceava

    Suceava, 720019

  • County Hospital Targoviste / Dermatology Department

    Targoviste, Dâmbovița County, 130086

  • Mures County Clinical Hospital / Dermatology Department

    Târgu Mureş, Mureș County, 540342

  • Municipal Emergency Hospital Timisoara / Dermatology Department

    Timișoara, Timiș County, 300077

  • County Emergency Hospital Zalau / Dermatology Department

    Zalău, Sălaj County, 450123

Other trials in Romania

About this study

Official title: Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.

Read the detailed description

Study hypothesis was based on the following rationale:

  • Psoriasis vulgaris is a chronic inflammatory skin disease with several extracutaneous manifestations and significant comorbidities (among others cardiovascular disease, metabolic syndrome, obesity and depression).
  • An increased prevalence of smoking among psoriasis patients, as compared with healthy subjects, has been observed in several studies
  • More recent studies suggest that cigarette smoking may trigger the development of psoriasis through oxidative, inflammatory and genetic mechanisms.Furthermore, smoking is associated with the clinical severity of psoriasis
  • Smoking also contributes to higher morbidity and mortality from smoking related disorders in these patients There is now some evidence that patients with psoriasis who smoke tend to be less responsive to treatment
Being tested
QUESTIONNAIRE ON SMOKING HABITS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QUESTIONNAIRE ON SMOKING HABITSBehavioural

    Data on smoking will include the age at which cigarette smoking began and ceased and the average amount smoked daily. Intensity (number of cigarettes smoked per day), duration of smoking (years), and time since cessation (years) will be categorized. Also, the smoking status of the patient prior psoriasis diagnosis will be assessed (smoker or non-smoker and years of smoking prior to psoriasis diagnosis).

    Smoking habit evaluation: baseline and changes in smoking habit at 12 and 24-weeks follow-up time points.

Study groups in NCT02570750
Study groupRoleWhat they receive
Group 1: smokers patients groupsmokers (more than 10 cigarettes per day)
Receives: Behavioral: QUESTIONNAIRE ON SMOKING HABITS
Group 2 : non-smokers patients groupSmoking status will be classified as current and never/former. Former smokers will be defined as those who had stopped smoking at least 1 year before being interviewed for this study
Receives: Behavioral: QUESTIONNAIRE ON SMOKING HABITS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24

    PASI 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 on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Baseline, Week 24

Secondary outcomes (5)
  1. Change From Baseline in Dermatology Life Quality Index (DLQI)

    The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

    Measured: Baseline, Week 12, 24

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

    PASI 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 on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.

    Measured: Week 12, 24

  3. Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24

    PASI 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 on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.

    Measured: Week 12, 24

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

    PASI 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 on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Week 12

  5. Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants

    PASI 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 on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index >30 kilogram per meter square were said to be obese in this outcome measure.

    Measured: Baseline, Week 12, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2015 (estimated)
  2. Study start7 May 2015
  3. Primary completion5 Dec 2016
  4. Study completion5 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02570750
Sponsor's protocol ID
B1801392
Status last verified
Jun 2018
First submitted
5 Oct 2015
Last updated
20 Dec 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Plaque Psoriasis, run by Pfizer at 30 sites in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.

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