Clinical trial NCT02468791: MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Autoimmune Diseases
Rituximab
Immune System Diseases
Joint Diseases
Rheumatic Diseases
Lead sponsor: Mabion SA
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinical Centre Banja Luka Location Paprikovac
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Centre University of Sarajevo
city: Sarajevo
country: Bosnia and Herzegovina
facility: General Hospital "Dr. Abdulah Nakas"
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Centre Tuzla
city: Tbilisi
country: Georgia
facility: Carabs Medline Ltd
city: Tbilisi
country: Georgia
facility: Cardio-Reanimation Center Ltd
city: Tbilisi
country: Georgia
facility: Diagnostic Service ltd
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
city: Tbilisi
country: Georgia
facility: MediClub Georgia
city: Tbilisi
country: Georgia
facility: Medicore Ltd
city: Tbilisi
country: Georgia
facility: Medulla-Chemotherapy and Immunotherapy Clinic
city: Białystok
country: Poland
facility: Centrum Miriada
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
city: Częstochowa
country: Poland
facility: Centrum Położnicze św Łukasza Sp.z.o.o
city: Dopiewo
country: Poland
facility: NSZOZ Unica CR
city: Elbląg
country: Poland
facility: Wojewódzki Szpital Zespolony
city: Kraków
country: Poland
facility: Małopolskie Centrum Medyczne S.C.
city: Kraków
country: Poland
facility: Szpital Uniwersytecki, Oddział Kliniczny Kliniki Chorób Wewnętrznych
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. J. Dietla
city: Lublin
country: Poland
facility: Ośrodek Badań Klinicznych
city: Lublin
country: Poland
facility: REUMED
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED. S.C.
city: Nowa Sól
country: Poland
facility: Centrum Medyczne Nowa Sól
city: Poznań
country: Poland
facility: SOLUMED
city: Poznań
country: Poland
facility: AL Klinika
city: Stalowa Wola
country: Poland
facility: NZOZ Poradnia Leczenia Osteoporozy i Chorób Narządu Ruchu
city: Sucha Beskidzka
country: Poland
facility: Zespół Opieki Zdrowotnej w Suchej Beskidzkiej
city: Ustroń
country: Poland
facility: Śląski Szpital Reumatologiczo-Rehabilitacyjny im. Generała Jerzego Ziętka
city: Warsaw
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A
city: Warszawa
country: Poland
facility: Linea Corporis Spółka z Ograniczoną Odpowiedzialnością
city: Warszawa
country: Poland
facility: IRMED
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: Warszawa
country: Poland
facility: Instytut Reumatologii
city: Zamość
country: Poland
facility: KO-MED Centra Kliniczne
city: Belgrade
country: Serbia
facility: Institute for Rheumatology - Belgrade
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Niska Banja
country: Serbia
facility: Institute for treatment and rehabilitation "Niska Banja"
city: Novi Sad
country: Serbia
facility: Clinical center of Vojvodina, Clinic for medical rehabilitation
city: Chernivtsi
country: Ukraine
facility: Communal Medical Institution "City Clinical Hospital no 3"
city: Ivano-Frankivsk
country: Ukraine
facility: National Medical University, Chair of Internal Medicine based on Ivano-Frankivsk Central Clinical City Hospital
city: Kharkiv,
country: Ukraine
facility: Department of Cardiology and Functional Diagnostics, Kharkiv Medical Academy of Postgraduated Education
city: Kharkiv
country: Ukraine
facility: Kharkiv City Clinical Hospital no 27
city: Kharkiv
country: Ukraine
facility: Regional Hospital Veterans of War
city: Kharkiv
country: Ukraine
facility: State Institute "L T Malaya Institute of Therapy of NAMS of Ukraine"
city: Kyiv
country: Ukraine
facility: Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
city: Kyiv
country: Ukraine
facility: National Scientific Center "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"
city: Ternopil
country: Ukraine
facility: Chair of Internal Medicine no 2 of Ternopil State Medical University
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Clinical Hospital of the Lviv Railways, Department of Therapy
city: Zaporizhzhia
country: Ukraine
facility: Clinical City Hospital no 7
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine
Study officials:
References: