MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468791
• Other study ID #: MabionCD20-001RA
• Status: Completed
• Phase: Phase 3
• Start date: May 2013
• Est. completion date: October 2017

Study information

• Verified date: May 2020
• Source: Mabion SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rituximab

Locations

Country	Name	City	State
Bosnia and Herzegovina	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
Georgia	Carabs Medline Ltd	Tbilisi
Georgia	Cardio-Reanimation Center Ltd	Tbilisi
Georgia	Diagnostic Service ltd	Tbilisi
Georgia	MediClub Georgia	Tbilisi
Georgia	Medicore Ltd	Tbilisi
Georgia	Medulla-Chemotherapy and Immunotherapy Clinic	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi
Poland	Centrum Miriada	Bialystok
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Poloznicze sw Lukasza Sp.z.o.o	Czestochowa
Poland	NSZOZ Unica CR	Dopiewo
Poland	Wojewódzki Szpital Zespolony	Elblag
Poland	Malopolskie Centrum Medyczne S.C.	Kraków
Poland	Szpital Specjalistyczny im. J. Dietla	Kraków
Poland	Szpital Uniwersytecki, Oddzial Kliniczny Kliniki Chorób Wewnetrznych	Kraków
Poland	Osrodek Badan Klinicznych	Lublin
Poland	REUMED	Lublin
Poland	NZOZ Lecznica MAK-MED. S.C.	Nadarzyn
Poland	Centrum Medyczne Nowa Sól	Nowa Sól
Poland	AL Klinika	Poznan
Poland	SOLUMED	Poznan
Poland	NZOZ Poradnia Leczenia Osteoporozy i Chorób Narzadu Ruchu	Stalowa Wola
Poland	Zespól Opieki Zdrowotnej w Suchej Beskidzkiej	Sucha Beskidzka
Poland	Slaski Szpital Reumatologiczo-Rehabilitacyjny im. Generala Jerzego Zietka	Ustron
Poland	Medica Pro Familia Sp. z o.o. S.K.A	Warsaw
Poland	Centrum Medyczne AMED	Warszawa
Poland	Instytut Reumatologii	Warszawa
Poland	IRMED	Warszawa
Poland	Linea Corporis Spólka z Ograniczona Odpowiedzialnoscia	Warszawa
Poland	KO-MED Centra Kliniczne	Zamosc
Serbia	Institute for Rheumatology - Belgrade	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Institute for treatment and rehabilitation "Niska Banja"	Niska Banja
Serbia	Clinical center of Vojvodina, Clinic for medical rehabilitation	Novi Sad
Ukraine	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	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	Department of Cardiology and Functional Diagnostics, Kharkiv Medical Academy of Postgraduated Education	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	Uzhgorod
Ukraine	Clinical City Hospital no 7	Zaporizhzhia
Ukraine	Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine	Zaporizhzhia

Sponsors (1)

Lead Sponsor	Collaborator
Mabion SA

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Georgia,  Poland,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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