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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Conditions
- Chronic Plaque Psoriasis
- 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 group | Role | What they receive |
|---|---|---|
| Group 1: smokers patients group | smokers (more than 10 cigarettes per day) Receives: Behavioral: QUESTIONNAIRE ON SMOKING HABITS | |
| Group 2 : non-smokers patients group | Smoking 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.
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)
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
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
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
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
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.
- First posted7 Oct 2015 (estimated)
- Study start7 May 2015
- Primary completion5 Dec 2016
- Study completion5 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
- ClinicalTrials.gov ID
- NCT02570750
- Acronym / sponsor ID
- B1801392
- Conditions
- Chronic Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 May 2015 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 5 Dec 2016 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 20 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: smokers patients group | – | Behavioral: QUESTIONNAIRE ON SMOKING HABITSsmokers (more than 10 cigarettes per day) |
| Group 2 : non-smokers patients group | – | Behavioral: QUESTIONNAIRE ON SMOKING HABITSSmoking 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUESTIONNAIRE ON SMOKING HABITSData 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. | Behavioural | Group 1: smokers patients group, Group 2 : non-smokers patients group |
Primary outcome
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
Time frame: Baseline, 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).
5 secondary outcomes
Change From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline, Week 12, 24
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
Time frame: Week 12, 24
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24
Time frame: Week 12, 24
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
Time frame: Week 12
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants
Time frame: Baseline, Week 12, 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
30 sites in 1 country: see every site and its status.
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.