MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis
1 other identifier
interventional
709
5 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started May 2013
Longer than P75 for phase_3 rheumatoid-arthritis
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMay 14, 2020
May 1, 2020
4 years
June 9, 2015
May 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
MabionCD20®
EXPERIMENTALA course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
MabThera®
ACTIVE COMPARATORA course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mabion SAlead
Study Sites (51)
Clinical Centre Banja Luka Location Paprikovac
Banja Luka, 78 000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, 88 000, Bosnia and Herzegovina
Clinical Centre University of Sarajevo
Sarajevo, 71 000, Bosnia and Herzegovina
General Hospital "Dr. Abdulah Nakas"
Sarajevo, 71 000, Bosnia and Herzegovina
University Clinical Centre Tuzla
Tuzla, 75 000, Bosnia and Herzegovina
Carabs Medline Ltd
Tbilisi, 0159, Georgia
Cardio-Reanimation Center Ltd
Tbilisi, 0159, Georgia
Diagnostic Service ltd
Tbilisi, 0159, Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159, Georgia
MediClub Georgia
Tbilisi, 0160, Georgia
Medicore Ltd
Tbilisi, 0186, Georgia
Medulla-Chemotherapy and Immunotherapy Clinic
Tbilisi, 0186, Georgia
Centrum Miriada
Bialystok, 15-297, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Centrum Położnicze św Łukasza Sp.z.o.o
Częstochowa, 42-202, Poland
NSZOZ Unica CR
Dopiewo, 62-069, Poland
Wojewódzki Szpital Zespolony
Elblag, 82-300, Poland
Małopolskie Centrum Medyczne S.C.
Krakow, 30-510, Poland
Szpital Uniwersytecki, Oddział Kliniczny Kliniki Chorób Wewnętrznych
Krakow, 31-531, Poland
Szpital Specjalistyczny im. J. Dietla
Krakow, 90-119, Poland
Ośrodek Badań Klinicznych
Lublin, 20-022, Poland
REUMED
Lublin, 20-582, Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, 05-830, Poland
Centrum Medyczne Nowa Sól
Nowa Sól, 67-100, Poland
SOLUMED
Poznan, 60-529, Poland
AL Klinika
Poznan, 61-113, Poland
NZOZ Poradnia Leczenia Osteoporozy i Chorób Narządu Ruchu
Stalowa Wola, 37-450, Poland
Zespół Opieki Zdrowotnej w Suchej Beskidzkiej
Sucha Beskidzka, 34-200, Poland
Śląski Szpital Reumatologiczo-Rehabilitacyjny im. Generała Jerzego Ziętka
Ustroń, 43-450, Poland
Linea Corporis Spółka z Ograniczoną Odpowiedzialnością
Warsaw, 00-235, Poland
IRMED
Warsaw, 01-157, Poland
Centrum Medyczne AMED
Warsaw, 01-518, Poland
Medica Pro Familia Sp. z o.o. S.K.A
Warsaw, 01-868, Poland
Instytut Reumatologii
Warsaw, 02-637, Poland
KO-MED Centra Kliniczne
Zamość, 22-400, Poland
Institute for Rheumatology - Belgrade
Belgrade, 11000, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Institute for treatment and rehabilitation "Niska Banja"
Niška Banja, 18205, Serbia
Clinical center of Vojvodina, Clinic for medical rehabilitation
Novi Sad, 21000, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 11, 2015
Study Start
May 1, 2013
Primary Completion
May 1, 2017
Study Completion
October 1, 2017
Last Updated
May 14, 2020
Record last verified: 2020-05