PsoriasisNCT01126619
A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis
An observational study of Psoriasis, run by Abbott at 25 sites in Turkey (Türkiye).
Trial summary
In recent years, biologics have changed the treatment of psoriasis, giving us additional therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow and are not teratogenic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 103 participants
- Where
- 25 sitesTurkey (Türkiye)
- Study dates
- May 2010to Sep 2011
- 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: University hospitals in Turkey
Who may be able to join
- Male or female patients ≥18 years old with moderate-to-severe psoriasis.
- Patients for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements.
- Patients who are able to understand and answer a self administered questionnaire.
- Patients signed an informed consent form stating that they agreed to have their photographs taken, analyzed, and included in a scientific publication.
Who cannot join
- Patients who do not consent to being photographed during the study.
- Females who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.
- Patients with untreated tuberculosis.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Turkey (Türkiye)25 sites
Site Reference ID/Investigator# 38780
Afyonkarahisar, 03000
Site Reference ID/Investigator# 27422
Ankara, 06000
Site Reference ID/Investigator# 38776
Ankara, 06000
Site Reference ID/Investigator# 38777
Ankara, 06000
Site Reference ID/Investigator# 38763
Ankara, 06100
Site Reference ID/Investigator# 38767
Aydin, 09000
Site Reference ID/Investigator# 38769
Bursa, 16000
Site Reference ID/Investigator# 38779
Edirne, 22030
Site Reference ID/Investigator# 38782
Gaziantep, 27000
Site Reference ID/Investigator# 38778
Hatay, 31000
Site Reference ID/Investigator# 38786
Isparta, 32000
Site Reference ID/Investigator# 38765
Istanbul, 34000
Site Reference ID/Investigator# 38771
Istanbul, 34093
Site Reference ID/Investigator# 38766
Istanbul, 34390
Site Reference ID/Investigator# 38770
Istanbul, 34668
Site Reference ID/Investigator# 38764
Izmir, 35000
Site Reference ID/Investigator# 44102
Kirikkale, 71100
Site Reference ID/Investigator# 44104
Kocaeli, 41380
Site Reference ID/Investigator# 38781
Konya, 42000
Site Reference ID/Investigator# 38773
Malatya, 44000
Site Reference ID/Investigator# 38768
Manisa, 45000
Site Reference ID/Investigator# 38772
Mersin, 33000
Site Reference ID/Investigator# 44262
Samsun, 55139
Site Reference ID/Investigator# 44103
Sivas, 58140
Site Reference ID/Investigator# 44105
Zonguldak, 67600
About this study
Official title: To Observe the Effectiveness and Safety of Anti-TNFs in Patients With Moderate to Severe Psoriasis
In recent years, biologics have changed the treatment of psoriasis, giving us additional therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow and are not teratogenic. Nevertheless, traditional systemic therapies continue to play an important role in the treatment of psoriasis in Turkey, even in patients who are requiring biologic treatments according to national recommendations. This study is designated to observe the effectiveness and safety of tumor necrosis factor inhibitors in patients with moderate to severe psoriasis.
Read the detailed description
Patients admitted to dermatology clinics, with moderate to severe psoriasis for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements. (Tumor necrosis factor inhibitors can be used for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A. Patients should be screened for latent tuberculosis and appropriate anti-tuberculosis prophylaxis must be initiated if latent tuberculosis is diagnosed). This is a national, multi-center, observational, prospective photographic atlas study in patients who are treated with tumor necrosis factor inhibitors for moderate to severe psoriasis in daily clinic according to Turkish regulations and reimbursement. Demographic data will be collected by the investigator at the beginning of the study. Every participant will be examined by the investigator and the Psoriasis Area Severity Index will be determined at the beginning of the study and at weeks 4, 8, 16 and 24. Each patient will be asked to fill out the Dermatology Life Quality Index at each visit. Each patient will be asked to fill out the Work Productivity and Activity Impairment Questionnaire: Psoriasis at the beginning and last visit (week 24). A standardized set of photographs will be taken at the beginning of the study and at weeks 4, 8, 16 and 24 by a dermatologist trained about standardized photograph positioning and settings. Psoriasis Area Severity Index, Dermatology Life Quality Index and Photographic scores will be statistically analyzed separately in order to evaluate treatment response.
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF | Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.
Measured: Baseline and Weeks 4, 8, 16 and 24
Percentage of Participants With 75% Reduction in PASI Score
The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Measured: Baseline and Weeks 4, 8, 16 and 24
Secondary outcomes (6)
Dynamic Physician Global Assessment (PGA) of Change in Psoriasis
In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from -5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement).
Measured: Baseline and Week 24
Dynamic Patient Global Assessment (PGA) of Change in Psoriasis
In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement).
Measured: Baseline and Week 24
Static Physician Global Assessment (PGA) of Psoriasis
In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:
Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis.
Measured: Baseline and Week 24
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.
Measured: Baseline and Weeks 4, 8, 16 and 24
Percent Change From Baseline in Work Productivity and Activity Impairment
The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):
- Percent work time missed in the last 7 days due to problems associated with psoriasis;
- Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;
- Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;
- Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.
Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.
Measured: Baseline and Week 24
Number of Participants With Adverse Events (AEs)
The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.
Please see the Adverse Event module below for additional details.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionSep 2011
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 PsoriasisStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmut Gucuk, MD, Study director, Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126619
- Sponsor's protocol ID
- P12-130
- Status last verified
- Oct 2012
- First submitted
- 18 May 2010
- Last updated
- 25 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Observe the Effectiveness and Safety of Anti-TNFs in Patients With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT01126619
- Acronym / sponsor ID
- P12-130
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 11 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years, biologics have changed the treatment of psoriasis, giving us additional therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow and are not teratogenic. Nevertheless, traditional systemic therapies continue to play an important role in the treatment of psoriasis in Turkey, even in patients who are requiring biologic treatments according to national recommendations. This study is designated to observe the effectiveness and safety of tumor necrosis factor inhibitors in patients with moderate to severe psoriasis.
Detailed description
Patients admitted to dermatology clinics, with moderate to severe psoriasis for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements. (Tumor necrosis factor inhibitors can be used for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A. Patients should be screened for latent tuberculosis and appropriate anti-tuberculosis prophylaxis must be initiated if latent tuberculosis is diagnosed). This is a national, multi-center, observational, prospective photographic atlas study in patients who are treated with tumor necrosis factor inhibitors for moderate to severe psoriasis in daily clinic according to Turkish regulations and reimbursement. Demographic data will be collected by the investigator at the beginning of the study. Every participant will be examined by the investigator and the Psoriasis Area Severity Index will be determined at the beginning of the study and at weeks 4, 8, 16 and 24. Each patient will be asked to fill out the Dermatology Life Quality Index at each visit. Each patient will be asked to fill out the Work Productivity and Activity Impairment Questionnaire: Psoriasis at the beginning and last visit (week 24). A standardized set of photographs will be taken at the beginning of the study and at weeks 4, 8, 16 and 24 by a dermatologist trained about standardized photograph positioning and settings. Psoriasis Area Severity Index, Dermatology Life Quality Index and Photographic scores will be statistically analyzed separately in order to evaluate treatment response.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF | – | –Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University hospitals in Turkey
Key inclusion criteria (4 listed)
- Male or female patients ≥18 years old with moderate-to-severe psoriasis.
- Patients for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements.
- Patients who are able to understand and answer a self administered questionnaire.
- Patients signed an informed consent form stating that they agreed to have their photographs taken, analyzed, and included in a scientific publication.
Key exclusion criteria (3 listed)
- Patients who do not consent to being photographed during the study.
- Females who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.
- Patients with untreated tuberculosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline and Weeks 4, 8, 16 and 24
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.
Percentage of Participants With 75% Reduction in PASI Score
Time frame: Baseline and Weeks 4, 8, 16 and 24
The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
6 secondary outcomes
Dynamic Physician Global Assessment (PGA) of Change in Psoriasis
Time frame: Baseline and Week 24
Dynamic Patient Global Assessment (PGA) of Change in Psoriasis
Time frame: Baseline and Week 24
Static Physician Global Assessment (PGA) of Psoriasis
Time frame: Baseline and Week 24
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline and Weeks 4, 8, 16 and 24
Percent Change From Baseline in Work Productivity and Activity Impairment
Time frame: Baseline and Week 24
Number of Participants With Adverse Events (AEs)
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mahmut Gucuk, MD study director
Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Abbott at 25 sites in Turkey (Türkiye).
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 4 inclusion and 3 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 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Turkey (Türkiye). 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 11 Oct 2012). 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?
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score (time frame: Baseline and Weeks 4, 8, 16 and 24). The study lists 2 primary outcomes in all. 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 25 Oct 2012.