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The impact of ustekinumab treatment on peripheral blood MAIT cells in patients with psoriasis

The impact of ustekinumab treatment on peripheral blood MAIT cells in patients with psoriasis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079484
Enrollment
Unknown
Registered
2024-01-04
Start date
2024-01-15
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

Sponsors

Department of Dermatology, Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 years old (2) psoriasis patients diagnosed by experienced dermatologists who can improve various examinations and epidemiological investigations.(3) After the dermatologist evaluated the patient's condition and reviewed the results of each examination, it was clear that the patient is suitable for using IL-12 / 23 inhibitor biological agents for psoriasis treatment.(4) The function level of the internal organs of the patient should meet the following requirements: a) Blood: Absolute neutrophil count (ANC) 2.0 * 10^9 / L, Platelet, 100 * 10^9 / L, Hemoglobin 9 g/dl; b) Liver: 1.5 times the normal upper limit of bilirubin, Aspartate aminotransferase (AST) and alanine transaminotransferase (ALT) 2.5 times upper normal limit; c) kidney: 1.25 times upper limit of serum creatinine or creatinine clearance 60 mL/min; (5) women of childbearing age must have a blood pregnancy test within 1 week before enrollment with negative results; (6) understand and voluntarily sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Age is <18 years old.(2) during pregnancy or lactation; (3) unable / refused to regulate the treatment of umab; (4) received systemic therapy or phototherapy within 4 weeks, Or receive topical treatment within 2 weeks; (5) patients who may need additional local therapy, phototherapy, or other systematic methods for disease treatment during the observation period; (6) the patients have the following unsuitable for treatment of the biological agents: a) patients with a history of malignant tumor or concurrent malignancy in the previous 5 years; b) patients who have received live attenuated vaccination within 4 weeks prior to the proposed first administration of the biological agents, Or patients who are scheduled to receive live attenuated vaccination during observation; c) any history of infection or recurrent infection requiring systemic antibiotic therapy within 2 weeks before the first dose of the organism; d) positive test result against human immunodeficiency disease (HIV) antibody (HIV Ab), And / or positive treponemundum-specific antibodies; And / or positive for hepatitis C virus antibody (HCV Ab), And tested positive by HCV-RNA reverse transcript polymerase chain reaction, Previous or current infection; And / or hepatitis B surface antigen (HbsAg) positive, Or positive hepatitis B core antibody (HBcAb) and positive by HBVDNA polymerase chain reaction, Suggesting the presence of current infection; e) severe, progressive, or uncontrolled renal, liver, blood, gastrointestinal, endocrine, pulmonary, and nervous system diseases; f) patients allergic to any excipients in the biologic or preparation; g) other conditions unsuitable for biologic after evaluation by the specialist.(7) having any other contraindications to relevant organisms or may put the subject at high risk of biological treatment related complications; (8) the investigator believes the subject is not able to complete the study or to comply with the requirements of the study (for management reasons or otherwise).

Design outcomes

Primary

MeasureTime frame
The portion of MAIT in lymphocytes;

Secondary

MeasureTime frame
inflammatory factor ;Expression of transcription factors in IL-17-associated MAIT cells;Expression of surface activation and depletion markers;Expression of the cell-surface chemokine receptors;

Countries

China

Contacts

Public ContactDeng Yunhua

Department of Dermatology, Tongji Hospital

874478678@qq.com+86 138 7126 9375

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026