PsoriasisPsoSATNCT07498543
Impact of Clinical and Psychological Factors on Satisfaction With Treatment in Psoriatic Patients on Biological Therapy
An observational study of Psoriasis, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Psoriasis is a chronic-recurrent inflammatory disease with a significant impact on patients' physical and psychological well-being. Fortunately, in recent years, the introduction of increasingly selective biologic therapies on the market has resulted in an excellent control of the disease, with high rates of complete… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Questionnaire
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients diagnosed with Psoriasis referred to the outpatient clinics of Dermatology and Venereology of FPG already treated with a systemic biologic drug for at least one year.
Who may be able to join
- Patients with age of more than18 years, of either sex;
- Diagnosis of Plaque Psoriasis, with or without concomitant arthritis;
- Patients who have been treated with systemic biologic drugs for at least one year whose available data on disease severity (PASI) and quality of life (DLQI) at baseline (before initiation treatment);
- Signature of written informed consent;
Who cannot join
- Presence of an already diagnosed psychiatric condition.
- Patients with variants of psoriasis (pustular, guttate, palmoplantar)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
About this study
Psoriasis is a chronic-recurrent inflammatory disease with a significant impact on patients' physical and psychological well-being. Fortunately, in recent years, the introduction of increasingly selective biologic therapies on the market has resulted in an excellent control of the disease, with high rates of complete (PASI100) or nearly complete (PASI90) in treated patients. At the same time, however, various studies have shown that these patients' quality of life and satisfaction with these therapies do not always correlate with the high levels of efficacy of these drugs, and this is often a limitation, as it has negative feedbacks on treatment adherence. This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that might best correlate with the satisfaction of psoriatic patients on therapy systemic with biologic drugs for more than one year afferent to the Dermatology Outpatient Clinics of the Policlinico Universitario A. Gemelli-IRCCS.
- Conditions
- Psoriasis
- Being tested
- Questionnaire
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
DLQI, PHQ 9, TSQM 2, DS14
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with psoriasis | Psoriasis already treated with a systemic biologic drug for at least one year. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9) - towards treatment, in a sample of psoriatic patients on therapy for more than one year with a biologic drug
The primary objective of the study is to evaluate satisfaction with treatment of psoriatic patients who have been on therapy for at least one year with a biologic drug. Satisfaction will be expressed in terms of a score derived from the Treatment Satisfaction Questionnaire for Medication (TSQM-9).(0-100) higher scores mean a better outcome.
Measured: 1 year
DLQI
Evaluate after 1 year of treatment with biologic drug:
- the DLQI (0-30). Lower scores mean a better outcome.
- the DLQI improvement from baseline
Measured: 1 year
Correlation of clinical variables on satisfaction of treatment
Evaluate the correlation of objectively measurable clinical variables such as:
- the age of onset and duration of disease (years)
- the presence of comorbidities
- the possible combination with other treatments
- the residual location of disease
- the presence/absence of psoriatic arthritis
- the residual PASI
- the PASI improvement from baseline (%)
- The achievement of an optimal response in terms of:
- Absolute PASI
- 90% and 100% reduction in PASI score from baseline
- DLQI between 0-5
Measured: 1 year
Secondary outcomes (1)
Correlation of Type D personality with satisfaction with treatment.
As a secondary objective, then orrelation of specific characteristics will also be assessed.
psychopathology (Type D personality, Depression) with satisfaction with treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start12 Oct 2023
- Primary completion12 Oct 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Caldarola, Catholic University of the Sacred Heart
- Investigators
- Giacomo Caldarola, Principal investigator, Università Cattolica del Sacro Cuore, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498543
- Sponsor's protocol ID
- 5601
- Acronym
- PsoSAT
- Status last verified
- Mar 2026
- First submitted
- 12 Oct 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical and Psychological Factors on Satisfaction With Treatment in Psoriatic Patients on Biological Therapy
- ClinicalTrials.gov ID
- NCT07498543
- Acronym / sponsor ID
- PsoSAT / 5601
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis is a chronic-recurrent inflammatory disease with a significant impact on patients' physical and psychological well-being. Fortunately, in recent years, the introduction of increasingly selective biologic therapies on the market has resulted in an excellent control of the disease, with high rates of complete (PASI100) or nearly complete (PASI90) in treated patients. At the same time, however, various studies have shown that these patients' quality of life and satisfaction with these therapies do not always correlate with the high levels of efficacy of these drugs, and this is often a limitation, as it has negative feedbacks on treatment adherence. This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that might best correlate with the satisfaction of psoriatic patients on therapy systemic with biologic drugs for more than one year afferent to the Dermatology Outpatient Clinics of the Policlinico Universitario A. Gemelli-IRCCS.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with psoriasis | – | Other: QuestionnairePsoriasis already treated with a systemic biologic drug for at least one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Psoriasis referred to the outpatient clinics of Dermatology and Venereology of FPG already treated with a systemic biologic drug for at least one year.
Key inclusion criteria (4 listed)
- Patients with age of more than18 years, of either sex;
- Diagnosis of Plaque Psoriasis, with or without concomitant arthritis;
- Patients who have been treated with systemic biologic drugs for at least one year whose available data on disease severity (PASI) and quality of life (DLQI) at baseline (before initiation treatment);
- Signature of written informed consent;
Key exclusion criteria (2 listed)
- Presence of an already diagnosed psychiatric condition.
- Patients with variants of psoriasis (pustular, guttate, palmoplantar)
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 |
|---|---|---|
| QuestionnaireDLQI, PHQ 9, TSQM 2, DS14 | Other | Patients diagnosed with psoriasis |
Primary outcome
Primary Outcome assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9) - towards treatment, in a sample of psoriatic patients on therapy for more than one year with a biologic drug
Time frame: 1 year
The primary objective of the study is to evaluate satisfaction with treatment of psoriatic patients who have been on therapy for at least one year with a biologic drug. Satisfaction will be expressed in terms of a score derived from the Treatment Satisfaction Questionnaire for Medication (TSQM-9).(0-100) higher scores mean a better outcome.
DLQI
Time frame: 1 year
Evaluate after 1 year of treatment with biologic drug: * the DLQI (0-30). Lower scores mean a better outcome. * the DLQI improvement from baseline
Correlation of clinical variables on satisfaction of treatment
Time frame: 1 year
Evaluate the correlation of objectively measurable clinical variables such as: * the age of onset and duration of disease (years) * the presence of comorbidities * the possible combination with other treatments * the residual location of disease * the presence/absence of psoriatic arthritis * the residual PASI * the PASI improvement from baseline (%) * The achievement of an optimal response in terms of: * Absolute PASI * 90% and 100% reduction in PASI score from baseline * DLQI between 0-5
1 secondary outcome
Correlation of Type D personality with satisfaction with treatment.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Giacomo Caldarola principal investigator
Università Cattolica del Sacro Cuore, Roma
1 site 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 Catholic University of the Sacred Heart at 1 site in Italy.
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 2 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Outcome assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9) - towards treatment, in a sample of psoriatic patients on therapy for more than one year with a biologic drug (time frame: 1 year). The study lists 3 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 26 Oct 2026.