Biomonitoring of inflammation, therapy response and regeneration in patients with rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis during therapy with Certolizumab Pegol - BIORAC

Charité Campus Charité Mitte0 sites137 target enrollmentJanuary 8, 2018

Overview

No summary available.

Registry

who.int

Start Date

January 8, 2018

End Date

January 19, 2018

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Charité Campus Charité Mitte

•The enrollment ensued according to the prescribing information of the medication CTZ. Every patient has to fulfill the following inclusion criteria:
•diagnosis in RA (ACR classification criteria), SpA (ASAS criteria) and PsoA (CASPAR)
•Is capable of understanding and signing an informed consent form
•An active RA and PsoA DAS28 \= 3,2; active spondyloarthritis with BASDAI \= 4 and spinal pain \=4 (NRS)
•Fulfilling the DGRh cirteria for the indicated therapy
•With contraception in woman of child\-bearing age during the time of treatment and at least up to 5 months after the last application

•If there will be one of the following exclusion criteria applicable, the patient can´t enroll in the study
•Heart failure (NYHA III/IV)
•Active tuberculosis
•Contraindication for the treatment with CTZ or a hypersensitivity against the contents
•Recent therapy with Anakinra or Abatacet, or in combination with CTZ is planed
•Is female and capable of bearing children and use any reasonable contraception