Plaque Psoriasis, Psoriatic ArthritisNCT04614831
A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis
An observational study of Plaque Psoriasis, Psoriatic Arthritis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
The study is a Worldwide Survey on the Understanding of Psoriatic Disease among Patients with Psoriasis and Psoriatic Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Plaque Psoriasis, Psoriatic Arthritis
- How many people
- 4,978 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Nov 2020to 3 Jun 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults with self-reported Psoriasis and/or Psoriatic Arthritis. Screening questions will be used to determine the eligibility for each respondent to the survey.
Who may be able to join
- Patients who self-report to have been diagnosed with Psoriasis or Psoriasis and Psoriatic Arthritis before or at the time of data collection
- Patients 18 years of age or older at the time of data collection
- Patients who did not participate in surveys regarding Psoriasis or Psoriatic Arthritis in the last 4 weeks
- Body Surface Area (BSA) of >5 to <10, with psoriasis affecting sensitive and/or prominent body parts: face, palms, hands, fingers, genitals, soles of feet or nails or a BSA of 10 and above, when psoriasis was at its worst
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psoriasis and Beyond: A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis
The study is a Worldwide Survey on the Understanding of Psoriatic Disease among Patients with Psoriasis and Psoriatic Arthritis.
Read the detailed description
This is a cross-sectional, quantitative online survey of patients with psoriasis with or without concomitant psoriatic arthritis. Following assessment of participant eligibility via a 5-minute online screener, the 25-minute internet-based survey will be conducted without any follow-up.
- Conditions
- Plaque Psoriasis, Psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic
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 |
|---|---|---|
| Psoriasis and Psoriatic Arthritis | The study population consists of adults who self-report to have been diagnosed with psoriasis with or without concomitant psoriatic arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
A web-based survey will be answered by the participants. Data collected for the analysis of the primary objective include validated patient-reported outcomes (such as DLQI), as well as responses to non-validated questions.
To assess patients' understanding of psoriasis and psoriatic arthritis as part of a systemic disease and the humanistic and physical burden of living with the condition.
Measured: 1 Day of survey
Secondary outcomes (1)
A web-based survey will be answered by the participants. The data collected for the analysis of the secondary objectives include validated tools (such as PAM-13), as well as responses to non-validated questions.
To assess the patient's perceptions and attitudes related to the relationship with their physician, the patient journey through the healthcare system, as well as barriers to self-management, diagnosis, patient perceptions on biologics, treatment expectations, and satisfaction with care.
Measured: 1 Day of Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start12 Nov 2020
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Psoriasis, Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614831
- Sponsor's protocol ID
- CAIN457A2023
- Status last verified
- Jul 2021
- First submitted
- 29 Oct 2020
- Last updated
- 21 Jul 2021
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriasis and Beyond: A Worldwide Survey on the Understanding of Psoriatic Disease Among Patients With Psoriasis and Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT04614831
- Acronym / sponsor ID
- CAIN457A2023
- Conditions
- Plaque Psoriasis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,978 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 4 Nov 2020 (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.
The study is a Worldwide Survey on the Understanding of Psoriatic Disease among Patients with Psoriasis and Psoriatic Arthritis.
Detailed description
This is a cross-sectional, quantitative online survey of patients with psoriasis with or without concomitant psoriatic arthritis. Following assessment of participant eligibility via a 5-minute online screener, the 25-minute internet-based survey will be conducted without any follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis and Psoriatic Arthritis | – | –The study population consists of adults who self-report to have been diagnosed with psoriasis with or without concomitant psoriatic arthritis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults with self-reported Psoriasis and/or Psoriatic Arthritis. Screening questions will be used to determine the eligibility for each respondent to the survey.
Key inclusion criteria (4 listed)
- Patients who self-report to have been diagnosed with Psoriasis or Psoriasis and Psoriatic Arthritis before or at the time of data collection
- Patients 18 years of age or older at the time of data collection
- Patients who did not participate in surveys regarding Psoriasis or Psoriatic Arthritis in the last 4 weeks
- Body Surface Area (BSA) of >5 to <10, with psoriasis affecting sensitive and/or prominent body parts: face, palms, hands, fingers, genitals, soles of feet or nails or a BSA of 10 and above, when psoriasis was at its worst
Key exclusion criteria (0 listed)
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
A web-based survey will be answered by the participants. Data collected for the analysis of the primary objective include validated patient-reported outcomes (such as DLQI), as well as responses to non-validated questions.
Time frame: 1 Day of survey
To assess patients' understanding of psoriasis and psoriatic arthritis as part of a systemic disease and the humanistic and physical burden of living with the condition.
1 secondary outcome
A web-based survey will be answered by the participants. The data collected for the analysis of the secondary objectives include validated tools (such as PAM-13), as well as responses to non-validated questions.
Time frame: 1 Day of Survey
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 21 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Plaque Psoriasis, Psoriatic Arthritis
Active, not recruitingObservational study
Psoriasis Longitudinal Assessment and Registry
Psoriasis
Not yet recruitingPhase 2
Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis
Psoriatic Arthritis (PsA)
Recruiting
Modifying PEST for Psoriatic Arthritis Screening
Plaque Psoriasis, Psoriatic Arthritis
RecruitingPhase 1
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
Active, not recruitingPhase 3
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Plaque Psoriasis, Psoriatic Arthritis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 0 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 21 Jul 2021. 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 Switzerland. 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?
A web-based survey will be answered by the participants. Data collected for the analysis of the primary objective include validated patient-reported outcomes (such as DLQI), as well as responses to non-validated questions. (time frame: 1 Day of survey). 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 21 Jul 2021.