MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
- Registration Number
- NCT02468791
- Lead Sponsor
- Mabion SA
- Brief Summary
The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.
- Detailed Description
Subjects who meet the criteria for participation in this study receive 2 intravenous infusions of MabionCD20® or MabThera® with two weeks interval in combination with methotrexate and folic acid. After the treatment period, patients are followed for 24 weeks, in order to continue checking safety. Therefore, the total study lasts 48 weeks. There is a possibility to repeat treatment after 6 months of the first infusions if subject meets the retreatment criteria.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 709
- Patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit
- 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
- History of current rheumatic autoimmune disease other than RA and current inflammatory joint disease other than RA
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MabThera® Rituximab A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval. MabionCD20® Rituximab A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
- Primary Outcome Measures
Name Time Method Percentage of patients in each treatment group achieving the primary efficacy endpoint of a ≥ 20% improvement on the American College of Rheumatology score (ACR20) at Week 24. 24 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
NSZOZ Unica CR
🇵🇱Dopiewo, Poland
IRMED
🇵🇱Warszawa, Poland
University Clinical Centre Tuzla
🇧🇦Tuzla, Bosnia and Herzegovina
Centrum Miriada
🇵🇱Białystok, Poland
Wojewódzki Szpital Zespolony
🇵🇱Elbląg, Poland
Małopolskie Centrum Medyczne S.C.
🇵🇱Kraków, Poland
Szpital Uniwersytecki, Oddział Kliniczny Kliniki Chorób Wewnętrznych
🇵🇱Kraków, Poland
Szpital Specjalistyczny im. J. Dietla
🇵🇱Kraków, Poland
Tbilisi Heart and Vascular Clinic
🇬🇪Tbilisi, Georgia
REUMED
🇵🇱Lublin, Poland
National Medical University, Chair of Internal Medicine based on Ivano-Frankivsk Central Clinical City Hospital
🇺🇦Ivano-Frankivsk, Ukraine
Clinical Centre Banja Luka Location Paprikovac
🇧🇦Banja Luka, Bosnia and Herzegovina
Clinical Centre University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Cardio-Reanimation Center Ltd
🇬🇪Tbilisi, Georgia
Diagnostic Service ltd
🇬🇪Tbilisi, Georgia
Medulla-Chemotherapy and Immunotherapy Clinic
🇬🇪Tbilisi, Georgia
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Ośrodek Badań Klinicznych
🇵🇱Lublin, Poland
NZOZ Lecznica MAK-MED. S.C.
🇵🇱Nadarzyn, Poland
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
MediClub Georgia
🇬🇪Tbilisi, Georgia
Medicore Ltd
🇬🇪Tbilisi, Georgia
Centrum Położnicze św Łukasza Sp.z.o.o
🇵🇱Częstochowa, Poland
AL Klinika
🇵🇱Poznań, Poland
Medica Pro Familia Sp. z o.o. S.K.A
🇵🇱Warsaw, Poland
Linea Corporis Spółka z Ograniczoną Odpowiedzialnością
🇵🇱Warszawa, Poland
State Institute "L T Malaya Institute of Therapy of NAMS of Ukraine"
🇺🇦Kharkiv, Ukraine
Uzhgorod Clinical Hospital of the Lviv Railways, Department of Therapy
🇺🇦Uzhgorod, Ukraine
NZOZ Poradnia Leczenia Osteoporozy i Chorób Narządu Ruchu
🇵🇱Stalowa Wola, Poland
Zespół Opieki Zdrowotnej w Suchej Beskidzkiej
🇵🇱Sucha Beskidzka, Poland
Instytut Reumatologii
🇵🇱Warszawa, Poland
Institute for Rheumatology - Belgrade
🇷🇸Belgrade, Serbia
Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine
🇺🇦Zaporizhzhia, Ukraine
Communal Medical Institution "City Clinical Hospital no 3"
🇺🇦Chernivtsi, Ukraine
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
🇺🇦Kyiv, Ukraine
Clinical City Hospital no 7
🇺🇦Zaporizhzhia, Ukraine
Regional Hospital Veterans of War
🇺🇦Kharkiv, Ukraine
University Clinical Hospital Mostar
🇧🇦Mostar, Bosnia and Herzegovina
General Hospital "Dr. Abdulah Nakas"
🇧🇦Sarajevo, Bosnia and Herzegovina
Carabs Medline Ltd
🇬🇪Tbilisi, Georgia
SOLUMED
🇵🇱Poznań, Poland
Centrum Medyczne Nowa Sól
🇵🇱Nowa Sól, Poland
Śląski Szpital Reumatologiczo-Rehabilitacyjny im. Generała Jerzego Ziętka
🇵🇱Ustroń, Poland
KO-MED Centra Kliniczne
🇵🇱Zamość, Poland
Centrum Medyczne AMED
🇵🇱Warszawa, Poland
Institute for treatment and rehabilitation "Niska Banja"
🇷🇸Niska Banja, Serbia
Department of Cardiology and Functional Diagnostics, Kharkiv Medical Academy of Postgraduated Education
🇺🇦Kharkiv,, Ukraine
Clinical center of Vojvodina, Clinic for medical rehabilitation
🇷🇸Novi Sad, Serbia
Kharkiv City Clinical Hospital no 27
🇺🇦Kharkiv, 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