The effect of infliximab on endothelial function in patients with psoriasis

Not Applicable

• Conditions: Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis; D011565, D015535

• Registration Number: JPRN-jRCTs031180367
• Lead Sponsor: TOYAMA SATOSHI

Brief Summary

o significant improvement of the reactive hyperemia index between before the 1st administration and 4 hours after the 3rd administration of study drug, the primary endpoint, was showed. The secondary end point, significant PASI score improvement was showed between before the 1st administration and after the 3rd administration of study drug, which means it improved skin symptoms of psoriasis. There were no significant change of frequency or severity of adverse events by this study drug.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2021-12-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients diagnosed as having psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, erythrodermic psoriasis
2. Patients at the age of 20 - 80 years when written informed consent is obtained
3. Patients who meet either of the following two criteria; (i) insufficiently treated with systemic therapies including phototherapy and skin lesions covering more than 10% of body surface area, (ii) severe skin and joint symptoms refractory to pre-existing treatments and quality of life is highly disturbed.
4. Patients from whom written informed consent is obtained after the sufficient explanation and understanding of this study

Exclusion Criteria

1. Patients who are treated with other biologics (including infliximab) within 3 months
2. Patients treated with cyclosporine within 2 weeks
3. Patients with the past history of severe hypersensitivity or anaphylaxis against infliximab or drugs including murine proteins.
4. Patients with or suspected of having malignancy
5. Patients with serious infection, such as sepsis and positivity of Hepatitis B virus antigen
6. Patients with active or the past history of tuberculosis
7. Patients with active or the past history of demyelinating diseases
8. Patients with congestive heart failure
9. Patients with serious liver diseases (more than 300 IU of AST or ALT)
10. Patients with serious kidney diseases (serum creatinine >= 2.0mg/dl)
11. Patients under or suspected of pregnancy
12. Patients under breast feeding
13. Patients who are regarded to be inappropriate for this study by doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage improvement in reactive hyperemia index measured by EndoPAT at 4 hours after the third infusion compared with the baseline

Secondary Outcome Measures

Name	Time	Method
The percentage improvement in reactive hyperemia index measured by EndoPAT at 4 hours after the first, second and third infusions compared with the baselines before each infusion<br>The percentage improvement in Psoriasis Area and Severity Index (PASI) score after the second and third infusions compared with the baseline<br>Systolic and diastolic blood pressure before the first, second, and third infusions and 8 weeks after the third infusion<br>HbA1c before the first, second, and third infusions and 8 weeks after the third infusion<br>T-chol, LDL, HDL and TG before the first, second, and third infusions and 8 weeks after the third infusion<br>High-sensitivity CRP before the first, second, and third infusions and 8 weeks after the third infusion<br>Serum levels of infliximab and anti-infliximab antibody before the first and third infusions