Comparison of the bacterial microbiota in the skin and gut of psoriasis patients before and after sytemic treatment with adalimumab and ustekinumab or cyclosporin - MIPSO

niversitätsklinikum Münster0 sites36 target enrollmentOctober 30, 2014

Overview

No summary available.

Registry

who.int

Start Date

October 30, 2014

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversitätsklinikum Münster

•Inclusion criteria for all patients:
•1\. Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI \= 10\).
•2\. \> 18 years (male and female).
•3\. Treatment according to the guidelines and standard therapies for
•psoriasis with adalimumab, ustekinumab or cyclosporine.
•Additional inclusion criteria for patients who will receive adalimumab or ustekinumab:
•1\.Patients with moderate or severe chronic plaque psoriasis who did not respond to other systemic therapy such as ciclosporine, methotrexate, or PUVA or patients with contraindications or intolerance to such a therapy.
•Additional inclusion criteria for patients who will receive ciclosporine:
•1\.Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI \= 10\) who are not adequately treatable with conventional systemic therapy.
•Are the trial subjects under 18? no

•Exclusion criteria for all patients:
•1\.Patients treated with systemic immunosuppressives, adalimumab, etanercept, ustekinumab or infliximab within a period of 5 half\-life periods of the respective drug before taking the initial skin swabs /biopsies.
•2\.Simultaneous therapy with systemic immunosuppressives.
•3\.Patients treated with antibiotics within at least 4 weeks before taking the initial skin swabs/biopsies or patients treated with antibiotics in the course of the trial with the exception of tuberculosis prophylaxis with Isoniazid.
•4\.Psoriasis patients who currently receive phototherapy or have received phototherapy within a period of 2 weeks before taking the initial skin swabs/biopsies.
•5\.Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in skin areas chosen for the skin swabs/biopsies. In skin areas chosen for the swabs/biopsies topical therapy is not allowed within 7 days before sampling.
•6\.Patients with relevant active infections (e.g. active tuberculosis or other severe infections such as sepsis and opportunistic infections).
•7\.HbsAG\-positive patients. HCV\-PCR\-positive patients.
•8\.HIV\-positive patients.
•9\.Current malignancies or history of malignancies.