The effect of infliximab on endothelial function in patients with psoriasis

JRCT ID: jRCTs031180367

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis
• Date of first enrollment: 20/02/2018
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Endothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.

Outcome(s)

• Primary Outcome: The percentage improvement in reactive hyperemia index measured by EndoPAT at 4 hours after the third infusion compared with the baseline

Secondary Outcome

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
The percentage improvement in Psoriasis Area and Severity Index (PASI) score after the second and third infusions compared with the baseline
Systolic and diastolic blood pressure before the first, second, and third infusions and 8 weeks after the third infusion
HbA1c before the first, second, and third infusions and 8 weeks after the third infusion
T-chol, LDL, HDL and TG before the first, second, and third infusions and 8 weeks after the third infusion
High-sensitivity CRP before the first, second, and third infusions and 8 weeks after the third infusion
Serum levels of infliximab and anti-infliximab antibody before the first and third infusions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: TOYAMA SATOSHI
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation
• Secondary ID(s): UMIN000027208