RemiRit
Project data
Project financing: 9 999 999.98 PLN (including financing for UMED: 833 293.80 PLN), financed by the Medical Research Agency (ABM)
Project description:
RemiRit is a phase IV multicenter clinical trial evaluating the efficacy and safety of a new immunosuppressive regimen using rituximab in patients with ANCA-associated vasculitis.
ANCA-associated vasculitides (AAV) are a group of rare or ultra-rare diseases. The annual incidence is estimated at 0.5-20 per million people. AAV is a systemic inflammation affecting mainly small vessels, which is characterized by necrotic and inflammatory changes in the vascular wall and the presence of circulating autoantibodies – ANCA. The basis of treatment of this group of diseases is immunosuppressive therapy, consisting of the remission induction phase and maintenance treatment. The induction treatment consists of high doses of glucocorticoids and an immunosuppressive drug: cyclophosphamide, rituximab or a combination of both, other drugs are used less frequently. Maintenance therapy consists of low doses of glucocorticoids and azathioprine or rituximab.
The aim of the study is to evaluate the efficacy and safety of an optimized regimen of induction and maintenance therapy with rituximab. One hundred sixty patients with new diagnosis or relapse of AAV will be enrolled in part I (induction treatment) and then re-randomized to part II (maintenance treatment).
In addition, it is planned to perform a whole exome sequencing analysis in order to determine the genetic predisposition to the development of the disease, its course and response to treatment.
Beneficiary
Consortium composed of:
Military Medical Institute – National Research Institute (Leader),
Medical University of Lodz (Partner),
Medical University of Gdansk (Partner),
Association of Patients with Systemic Vasculitis “Vasculitis” (Partner).
Coordinating Principal Investigator
prof. Stanislaw Niemczyk, MD, PhD
Department of Internal Diseases, Nephrology and Dialysis,
Military Medical Institute – National Research Institute
UMED Site Principal Investigator
prof. Ilona Kurnatowska, MD, PhD