DEPARTMENT OF RHEUMATOLOGY AND IMMUNOLOGY

INTRODUCTION

The department operates in the Akác utca block of the University of Pécs. There are three units for inpatients: Rheumatology (22 beds), Internal medicine Immunology (20 beds), and Early Musculoskeletal Rehabilitation (20 beds). These units are also supported corresponding outpatient services.

The main area and also scientific interest of our department is systemic autoimmune diseases.
These include systemic sclerosis, systemic lupus erythematosus, Sjögren's syndrome and idiopathic inflammatory myopathies (myositis, systemic vasculitis).

Our department also provides treatments for chronic inflammatory rheumatic diseases (rheumatoid arthritis, Bechterew's disease, psoriatic arthritis). We are a regional centre which covers 3 counties of Hungary.

We have significant, 20 years long experience in clinical trials.

Besides our skills in musculoskeletal diseases, we have a broad knowledge of internal medicine. This is vital for the effective care of patients with systemic autoimmune diseases to be able to understand the immunological processes. As part of this, our department provides care for immunocompromised patients (Common Variable Immunodeficiency, CVID in adults) in the region.

We have extensive experience how the above pathologies affect the internal organs and survival, with particular regard to the scleroderma family.

We have a biobank (biological sample repository) for a decade. Our department has excellent facilities for the collection, preparation (eg. temperature-controlled centrifuge) and storage (-20 and -80 degree freezers) of biological samples. Our support staff is also outstanding with nurses and laboratory colleagues speaking various languages.

Number of clinical trial investigators with Good Clinical Practice (GCP) certificate: 3
Number of clinical trial doctors with Good Clinical Practice (GCP) certificate: 6
Number of specialist doctors with Clinical Pharmacology certificate: 0

EQUIPMENT FOR CLINICAL TRIALS

freezer - 75°C
ultrasound device for examining joints
12-channel ECG device
capillary microscope
desktop centrifuge
thermostat

REFERENCE CLINICAL TRIALS

	Protocol Identifier	Name of Study	Principal Investigator
1	BAY 63-2521/16277	Randomized, double-blind, placebocontrolled, phase II trial to evaluate the efficacy and safety of riociguat in patients with diffuse cutaneous systemic sclerosis (dcSSc).	Prof. Dr. László Czirják
2	WA29767	A phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tocilizumab compared with placebo in patients with systemic sclerosis.	Dr. Tünde Minier
3	ML25503	Nyílt, multicentrikus, beavatkozással nem járó vizsgálat a tocilizumab biztonságosságának, tolerálhatóságának és hatékonyságának elemzésére.	Prof. Dr. László Czirják

PRINCIPAL INVESTIGATORS

Dr. Gábor Kumánovics

SCIENTIFIC DEGREE
POSITION
QUALIFICATIONS
SCIENTIFIC INTEREST
REFERENCE CLINICAL TRIALS	A Phase II, Multicenter International Indication: Raynaud, Sub-Investigator (2003) A Phase II, Multicenter International Indication: Scleroderma skin, Principal Investigator (2008-2009) Multicenter International Indication: Scleroderma PAH, Observational Study, Sub Investigator (2010-2011) Phase III, Multicenter International Indication: Scleroderma PAH, Sub Investigator (2010-2013) Phase III, Multicenter International Indication: Ulcers in scleroderma, Principal Investigator (2011-2013) Phase IIb, Multicenter International Indication: scleroderma skin, Sub Investigator (2014-2016)
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 3-4

Dr. GÉZÁNÉ SARLÓS, Dr. CECÍLIA VARJÚ

SCIENTIFIC DEGREE	PhD, Med. Habil.
POSITION	University Associate Professor
QUALIFICATIONS	Rheumatology, Clinical immunology-allergology, Rehabilitation medicine
SCIENTIFIC INTEREST	myositis, systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis
REFERENCE CLINICAL TRIALS	BAY 63-2521/16277: Multicenter International, Systemic Sclerosis, Phase III, Sub Investigator Number of patiens: 5 WA17822: Phase III, Rheumatoid Arthritis, Number of patiens: 4 WA18695: Phase III, Rheumatoid Arthritis, Number of patiens: 4
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 3-4

Dr. TÜNDE MINIER

SCIENTIFIC DEGREE	PhD
POSITION	University Assistant Professor
QUALIFICATIONS	Rheumatology, Clinical immunology-allergology
SCIENTIFIC INTEREST	systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis
REFERENCE CLINICAL TRIALS	WA 29767: Multicenter International, Systemic Sclerosis, Phase III. Principal Investigator BAY 63-2521/16277: Multicenter International, Systemic Sclerosis, Phase III. Sub Investigator
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 3-4

STUDY TEAM

Study Coordinators

We carry out clinical trials by using the Coordination Centre for Clinical Trials (KVKK).

Study Nurses

The department has 2 study nurses.

Number of study nurses with master degree (MSc): 2
Number of study nurses with bachelor degree (BSc): 0
Number of study nurses with further education degree: 0

Name	Phone	E-mail
Boglárka Balaton Ságiné	+36 72 536 827	balaton.boglarka@pte.hu
Ágnes Ágoston-Szabó	+36 72 536 985	szabo.agnes@pte.hu

Created: 10/03/2019
Last updated: 03.10.2019.