MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
NCT ID: NCT02468791
Last Updated: 2020-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
709 participants
INTERVENTIONAL
2013-05-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MabionCD20®
A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Rituximab
MabThera®
A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Rituximab
Interventions
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Rituximab
Eligibility Criteria
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Inclusion Criteria
* Patients who are naive to tumor necrosis factor (TNF) antagonists or any other monoclonal antibody therapies
* Patients who have had an inadequate response to an adequate regimen of methotrexate
Exclusion Criteria
* Contraindications according to the MabThera SmPC and every serious coexisting diseases which, in the Investigator's opinion, would preclude subject participation
* Positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody, hepatitis C antibody
* Prior treatment with rituximab, other anti-CD20 mAb, anti-TNF-alpha drug or any other monoclonal antibodies
* Pregnancy or lactation or women planning to get pregnant during the course of the study and/or within 12 months post last study drug infusion
* Allergic reaction or intolerance to rituximab, MabionCD20 or any of their components
* Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or previous treatment of any lymphocyte-depleting therapies
18 Years
80 Years
ALL
No
Sponsors
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Mabion SA
INDUSTRY
Responsible Party
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Locations
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Clinical Centre Banja Luka Location Paprikovac
Banja Luka, , Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, , Bosnia and Herzegovina
Clinical Centre University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
General Hospital "Dr. Abdulah Nakas"
Sarajevo, , Bosnia and Herzegovina
University Clinical Centre Tuzla
Tuzla, , Bosnia and Herzegovina
Carabs Medline Ltd
Tbilisi, , Georgia
Cardio-Reanimation Center Ltd
Tbilisi, , Georgia
Diagnostic Service ltd
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, , Georgia
MediClub Georgia
Tbilisi, , Georgia
Medicore Ltd
Tbilisi, , Georgia
Medulla-Chemotherapy and Immunotherapy Clinic
Tbilisi, , Georgia
Centrum Miriada
Bialystok, , Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Centrum Położnicze św Łukasza Sp.z.o.o
Częstochowa, , Poland
NSZOZ Unica CR
Dopiewo, , Poland
Wojewódzki Szpital Zespolony
Elblag, , Poland
Małopolskie Centrum Medyczne S.C.
Krakow, , Poland
Szpital Uniwersytecki, Oddział Kliniczny Kliniki Chorób Wewnętrznych
Krakow, , Poland
Szpital Specjalistyczny im. J. Dietla
Krakow, , Poland
Ośrodek Badań Klinicznych
Lublin, , Poland
REUMED
Lublin, , Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, , Poland
Centrum Medyczne Nowa Sól
Nowa Sól, , Poland
SOLUMED
Poznan, , Poland
AL Klinika
Poznan, , Poland
NZOZ Poradnia Leczenia Osteoporozy i Chorób Narządu Ruchu
Stalowa Wola, , Poland
Zespół Opieki Zdrowotnej w Suchej Beskidzkiej
Sucha Beskidzka, , Poland
Śląski Szpital Reumatologiczo-Rehabilitacyjny im. Generała Jerzego Ziętka
Ustroń, , Poland
Linea Corporis Spółka z Ograniczoną Odpowiedzialnością
Warsaw, , Poland
IRMED
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Medica Pro Familia Sp. z o.o. S.K.A
Warsaw, , Poland
Instytut Reumatologii
Warsaw, , Poland
KO-MED Centra Kliniczne
Zamość, , Poland
Institute for Rheumatology - Belgrade
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Institute for treatment and rehabilitation "Niska Banja"
Niška Banja, , Serbia
Clinical center of Vojvodina, Clinic for medical rehabilitation
Novi Sad, , Serbia
Communal Medical Institution "City Clinical Hospital no 3"
Chernivtsi, , Ukraine
National Medical University, Chair of Internal Medicine based on Ivano-Frankivsk Central Clinical City Hospital
Ivano-Frankivsk, , Ukraine
Department of Cardiology and Functional Diagnostics, Kharkiv Medical Academy of Postgraduated Education
Kharkiv, , Ukraine
Kharkiv City Clinical Hospital no 27
Kharkiv, , Ukraine
Regional Hospital Veterans of War
Kharkiv, , Ukraine
State Institute "L T Malaya Institute of Therapy of NAMS of Ukraine"
Kharkiv, , Ukraine
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
Kyiv, , Ukraine
National Scientific Center "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"
Kyiv, , Ukraine
Chair of Internal Medicine no 2 of Ternopil State Medical University
Ternopil, , Ukraine
Uzhgorod Clinical Hospital of the Lviv Railways, Department of Therapy
Uzhhorod, , Ukraine
Clinical City Hospital no 7
Zaporizhzhia, , Ukraine
Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine
Zaporizhzhia, , Ukraine
Countries
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Other Identifiers
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MabionCD20-001RA
Identifier Type: -
Identifier Source: org_study_id
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