PsoriasisNCT05547490
A Study to Assess Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Participants With Moderate-To-Severe Plaque Psoriasis
An observational study of Psoriasis, run by Bristol-Myers Squibb at 2 sites in China.
Trial summary
The purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (PsO) as well as their unmet medical needs and disease burden in real-world setting in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 3,506 participants
- Where
- 2 sitesChina
- Study dates
- 31 Oct 2022to 28 Apr 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of participants experiencing moderate-to-severe plaque PsO, who have at least one clinical visit (either outpatient or inpatient visit) between 1st January 2018 and 31st December 2021.
Who may be able to join
- Diagnosis of moderate-to-severe plaque PsO either confirmed by a dermatologist or meeting criteria of: BSA ≥ 3% or PASI ≥ 3 or Dermatology Life Quality Index (DLQI) ≥ 6.
Who cannot join
- Participating in Randomized controlled trial (RCT) between 1st January 2018 and 31st December 2021, if there was any.
- Diagnosis of erythrodermic psoriasis, pustular psoriasis or guttate psoriasis.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Local Institution - 0002
Beijing, Beijing Municipality, 100050
Local Institution - 0001
Nanjing, Jiangsu, 210042
About this study
Official title: Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Patients With Moderate-To-Severe Plaque Psoriasis in Real-World Settings in China
The purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (PsO) as well as their unmet medical needs and disease burden in real-world setting in China.
- Conditions
- Psoriasis
- Keywords
- Moderate to Severe Plaque PsO
- 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 |
|---|---|---|
| Moderate-to-severe Plaque PsO | Participants experiencing moderate-to-severe plaque PsO, who have had at least one clinical visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of demographic characteristics: Age
Measured: Baseline
Distribution of demographic characteristics: Sex
Measured: Baseline
Distribution of clinical characteristics: Height
Measured: Baseline
Distribution of clinical characteristics: Weight
Measured: Baseline
Distribution of clinical characteristics: Body Mass Index (BMI)
Measured: Baseline
Distribution of clinical characteristics: Disease duration
Measured: Baseline
Distribution of clinical characteristics: Severity of PsO
Measured: Baseline
Distribution of clinical characteristics: Comorbidities
Measured: Baseline
Treatment patterns: Drug categories treated during study period
Measured: Up to 4 Years
Treatment patterns: Drug names treated during study period
Measured: Up to 4 Years
Treatment patterns: Medication dosage
Measured: Up to 4 Years
Treatment patterns: Drug's administration frequency
Measured: Up to 4 Years
Treatment patterns: Reason for treatment change during study period
Measured: Up to 4 Years
Treatment patterns: Treatment duration of each drug during study period
Measured: Up to 4 Years
Treatment patterns: Treatment sequence
Measured: Up to 4 Years
Treatment patterns: Change of treatment pattern
Measured: Up to 4 Years
Secondary outcomes (7)
Number of participants achieving Body Surface Area of <3% during study period
Measured: Up to 4 Years
Psoriasis Area and Severity (PASI) Index
Measured: Up to 4 Years
Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period
Measured: Up to 4 Years
Healthcare resource utilization (HCRU)
HCRU will include visit date, visit type, cost, inpatient visits, outpatient visits, length of stay, and direct medical cost.
Measured: Up to 4 Years
Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA)
PtGA of psoriasis is an indicator of disease severity of PsO measured using a single-item, five- point scale ranging from 0 (clear) to 4 (severe). Category labels include 'clear', 'almost clear', 'mild', 'moderate' and 'severe'.
Measured: Up to 4 Years
Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI)
DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. Each item has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater HRQoL impairment.
Measured: Up to 4 Years
Evaluation of patient reported outcome measure: EQ-5D-3L
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension, participant is asked to choose one of the 3 levels (no problems, some problems, and extreme problems) to indicate his/her health state. This decision results into a 1-digit number and the digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.
Measured: Up to 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start31 Oct 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
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.
- More trials run by Bristol-Myers SquibbThe 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
- Retrospective
- Enrolment
- 3,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547490
- Sponsor's protocol ID
- IM011-206
- Status last verified
- Dec 2023
- First submitted
- 16 Sep 2022
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization Among Adult Patients With Moderate-To-Severe Plaque Psoriasis in Real-World Settings in China
- ClinicalTrials.gov ID
- NCT05547490
- Acronym / sponsor ID
- IM011-206
- Conditions
- Psoriasis
- Keywords
- Moderate to Severe Plaque PsO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,506 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 21 Sep 2022 (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 purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (PsO) as well as their unmet medical needs and disease burden in real-world setting in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-severe Plaque PsO | – | –Participants experiencing moderate-to-severe plaque PsO, who have had at least one clinical visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of participants experiencing moderate-to-severe plaque PsO, who have at least one clinical visit (either outpatient or inpatient visit) between 1st January 2018 and 31st December 2021.
Key inclusion criteria (1 listed)
- Diagnosis of moderate-to-severe plaque PsO either confirmed by a dermatologist or meeting criteria of: BSA ≥ 3% or PASI ≥ 3 or Dermatology Life Quality Index (DLQI) ≥ 6.
Key exclusion criteria (2 listed)
- Participating in Randomized controlled trial (RCT) between 1st January 2018 and 31st December 2021, if there was any.
- Diagnosis of erythrodermic psoriasis, pustular psoriasis or guttate psoriasis.
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
Distribution of demographic characteristics: Age
Time frame: Baseline
Distribution of demographic characteristics: Sex
Time frame: Baseline
Distribution of clinical characteristics: Height
Time frame: Baseline
Distribution of clinical characteristics: Weight
Time frame: Baseline
Distribution of clinical characteristics: Body Mass Index (BMI)
Time frame: Baseline
Distribution of clinical characteristics: Disease duration
Time frame: Baseline
Distribution of clinical characteristics: Severity of PsO
Time frame: Baseline
Distribution of clinical characteristics: Comorbidities
Time frame: Baseline
Treatment patterns: Drug categories treated during study period
Time frame: Up to 4 Years
Treatment patterns: Drug names treated during study period
Time frame: Up to 4 Years
Treatment patterns: Medication dosage
Time frame: Up to 4 Years
Treatment patterns: Drug's administration frequency
Time frame: Up to 4 Years
Treatment patterns: Reason for treatment change during study period
Time frame: Up to 4 Years
Treatment patterns: Treatment duration of each drug during study period
Time frame: Up to 4 Years
Treatment patterns: Treatment sequence
Time frame: Up to 4 Years
Treatment patterns: Change of treatment pattern
Time frame: Up to 4 Years
7 secondary outcomes
Number of participants achieving Body Surface Area of <3% during study period
Time frame: Up to 4 Years
Psoriasis Area and Severity (PASI) Index
Time frame: Up to 4 Years
Number of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period
Time frame: Up to 4 Years
Healthcare resource utilization (HCRU)
Time frame: Up to 4 Years
Evaluation of patient reported outcome measure: Patients' global assessment of disease activity (PtGA)
Time frame: Up to 4 Years
Evaluation of patient reported outcome measure: Dermatology life quality index (DLQI)
Time frame: Up to 4 Years
Evaluation of patient reported outcome measure: EQ-5D-3L
Time frame: Up to 4 Years
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 18 Dec 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 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 Bristol-Myers Squibb at 2 sites in China.
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 1 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Distribution of demographic characteristics: Age (time frame: Baseline). The study lists 16 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 18 Dec 2023.