Plaque PsoriasisNCT07730619
To Explore the Influencing Factors and Solutions for Patients With Plaque Psoriasis Undergoing Relapse
An observational study of Plaque Psoriasis and Biologic Agents, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
In recent years, an increasing number of patients who have experienced poor efficacy or adverse drug reactions using traditional treatment regimens have received biologic therapy and achieved satisfactory treatment results. However, we also found that some patients have poor reactions to biological agents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plaque Psoriasis, Biologic Agents, Relapse
- What is being tested?
- Diagnosis and Physical Examination of Psoriasis
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study retrospectively selected plaque psoriasis patients who received biologic treatment in the dermatology department of our hospital from December 2022 to December 2024.
Who may be able to join
- Diagnosed as plaque psoriasis.
- Received biological therapy for more than six months.
- Voluntarily participate in this study, with normal communication and understanding abilities.
- Recurrent group: Patients with initial treatment effective (PGA or BSA improvement reduced by more than 75% from baseline), PGA ≥ 3 or BSA decreased by less than 50% from baseline after a period of time [218], and who were treated in the dermatology department of our hospital.
- Control group: Treatment effective (PGA maintained at 0/1 or BSA improvement decreased by more than 75% from baseline), and no recurrence as mentioned in ④ occurred.
Who cannot join
- Patients with other types of psoriasis.
- Pregnant patients
- Patients who refuse to cooperate with medical staff questionnaire surveys or refuse to provide auxiliary testing or examination materials.
Trial locations and contacts
1 site in 1 country.
China1 site
Dermatology Department of the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
In recent years, an increasing number of patients who have experienced poor efficacy or adverse drug reactions using traditional treatment regimens have received biologic therapy and achieved satisfactory treatment results. However, we also found that some patients have poor reactions to biological agents. Biological agents are often the final treatment choice for most patients, and patients often have high expectations for this treatment plan. Therefore, exploring the factors that affect the efficacy of biological agents and effective follow-up treatment plans when there is poor response to biological agents is of great significance for the treatment of psoriasis patients.
The main research objective of this project is to observe and record the clinical characteristics and efficacy of plaque psoriasis patients treated with biological agents in the real world. 2. Explore the influencing factors of recurrence in plaque psoriasis patients receiving biological therapy in the real world, in order to increase awareness and awareness of this phenomenon, and provide guidance for preventing recurrence after biological therapy. 3. Record the follow-up treatment plans or response measures for recurrent patients, and compare the efficacy of different treatment plans.
This study is a case-control study that recruited patients with plaque psoriasis who have received biological therapy for more than half a year. A questionnaire survey was conducted to understand their general information, disease-related clinical data, and laboratory examination data. Univariate analysis was used to compare all variables between groups, and logistic regression analysis was performed on variables with statistical differences. Corresponding ROC curves were then drawn. Perform a separate analysis of the Adalimumab group according to the above steps. In addition, descriptive analysis was conducted on the characteristics that may be related to the disease in the recurrence group, and the efficacy of different treatment plans after recurrence was compared.
- Conditions
- Plaque Psoriasis, Biologic Agents, Relapse, Influence Factors
- Being tested
- Diagnosis and Physical Examination of Psoriasis
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis and Physical Examination of PsoriasisDiagnostic test
This study divided patients with plaque psoriasis treated with biological agents into a recurrent group and a non recurrent group based on whether they recurred or not
| Study group | Role | What they receive |
|---|---|---|
| Recurrent group | Recurrence after biological therapy Receives: Diagnostic Test: Diagnosis and Physical Examination of Psoriasis | |
| Control group | No recurrence after treatment with biological agents Receives: Diagnostic Test: Diagnosis and Physical Examination of Psoriasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Information
Age, gender, occupation, education, height, weight, abdominal circumference, history of smoking or excessive drinking, dietary preferences, sleep quality, exercise status
Measured: 12/1/2022-12/1/2024
Psoriasis related information
The duration of illness, the name and administration scheme of the biological agent, the age when using the biological agent, the age of the first onset of psoriasis, the body surface involved area (BSA) of the skin lesions when injecting the first dose of biological agent, whether to comply with medical advice, whether to have psoriasis comorbidity, whether to treat other diseases at the same time, whether to have a family history of psoriasis, whether to involve joints, whether to involve special parts, whether to have infectious diseases during the treatment period, whether to vaccinate COVID-19 vaccine
Measured: 12/1/2022-12/1/2024
Secondary outcomes (2)
Laboratory testing indicators
Blood routine test (mainly collecting leukocyte series), liver and kidney function, blood lipids, TB infection T cell detection, five items of hepatitis B, Th subgroup cytokines series, eight items of immunity, antinuclear antibody titer, C-reactive protein
Measured: 12/1/2022-12/1/2024
Imaging examination
chest X-ray or CT, abdominal ultrasound
Measured: 12/1/2022-12/1/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Dec 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yan, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730619
- Sponsor's protocol ID
- XJTU1AF2024LSYY-171
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Influencing Factors and Solutions for Patients With Plaque Psoriasis Undergoing Relapse
- ClinicalTrials.gov ID
- NCT07730619
- Acronym / sponsor ID
- XJTU1AF2024LSYY-171
- Conditions
- Plaque Psoriasis, Biologic Agents, Relapse, Influence Factors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Jul 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.
In recent years, an increasing number of patients who have experienced poor efficacy or adverse drug reactions using traditional treatment regimens have received biologic therapy and achieved satisfactory treatment results. However, we also found that some patients have poor reactions to biological agents. Biological agents are often the final treatment choice for most patients, and patients often have high expectations for this treatment plan. Therefore, exploring the factors that affect the efficacy of biological agents and effective follow-up treatment plans when there is poor response to biological agents is of great significance for the treatment of psoriasis patients.
The main research objective of this project is to observe and record the clinical characteristics and efficacy of plaque psoriasis patients treated with biological agents in the real world. 2. Explore the influencing factors of recurrence in plaque psoriasis patients receiving biological therapy in the real world, in order to increase awareness and awareness of this phenomenon, and provide guidance for preventing recurrence after biological therapy. 3. Record the follow-up treatment plans or response measures for recurrent patients, and compare the efficacy of different treatment plans.
This study is a case-control study that recruited patients with plaque psoriasis who have received biological therapy for more than half a year. A questionnaire survey was conducted to understand their general information, disease-related clinical data, and laboratory examination data. Univariate analysis was used to compare all variables between groups, and logistic regression analysis was performed on variables with statistical differences. Corresponding ROC curves were then drawn. Perform a separate analysis of the Adalimumab group according to the above steps. In addition, descriptive analysis was conducted on the characteristics that may be related to the disease in the recurrence group, and the efficacy of different treatment plans after recurrence was compared.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent group | – | Diagnostic Test: Diagnosis and Physical Examination of PsoriasisRecurrence after biological therapy |
| Control group | – | Diagnostic Test: Diagnosis and Physical Examination of PsoriasisNo recurrence after treatment with biological agents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study retrospectively selected plaque psoriasis patients who received biologic treatment in the dermatology department of our hospital from December 2022 to December 2024.
Key inclusion criteria (5 listed)
- Diagnosed as plaque psoriasis.
- Received biological therapy for more than six months.
- Voluntarily participate in this study, with normal communication and understanding abilities.
- Recurrent group: Patients with initial treatment effective (PGA or BSA improvement reduced by more than 75% from baseline), PGA ≥ 3 or BSA decreased by less than 50% from baseline after a period of time [218], and who were treated in the dermatology department of our hospital.
- Control group: Treatment effective (PGA maintained at 0/1 or BSA improvement decreased by more than 75% from baseline), and no recurrence as mentioned in ④ occurred.
Key exclusion criteria (3 listed)
- Patients with other types of psoriasis.
- Pregnant patients
- Patients who refuse to cooperate with medical staff questionnaire surveys or refuse to provide auxiliary testing or examination materials.
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 |
|---|---|---|
| Diagnosis and Physical Examination of PsoriasisThis study divided patients with plaque psoriasis treated with biological agents into a recurrent group and a non recurrent group based on whether they recurred or not | Diagnostic test | Control group, Recurrent group |
Primary outcome
General Information
Time frame: 12/1/2022-12/1/2024
Age, gender, occupation, education, height, weight, abdominal circumference, history of smoking or excessive drinking, dietary preferences, sleep quality, exercise status
Psoriasis related information
Time frame: 12/1/2022-12/1/2024
The duration of illness, the name and administration scheme of the biological agent, the age when using the biological agent, the age of the first onset of psoriasis, the body surface involved area (BSA) of the skin lesions when injecting the first dose of biological agent, whether to comply with medical advice, whether to have psoriasis comorbidity, whether to treat other diseases at the same time, whether to have a family history of psoriasis, whether to involve joints, whether to involve special parts, whether to have infectious diseases during the treatment period, whether to vaccinate COVID-19 vaccine
2 secondary outcomes
Laboratory testing indicators
Time frame: 12/1/2022-12/1/2024
Imaging examination
Time frame: 12/1/2022-12/1/2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 and Biologic Agents, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 5 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 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 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?
This study is still under way. Results are not available in the source record yet.
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?
General Information (time frame: 12/1/2022-12/1/2024). 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 28 Jul 2026.