search
Back to results

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Mabion SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Autoimmune Diseases, Rituximab, Immune System Diseases, Joint Diseases, Rheumatic Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MabionCD20®

MabThera®

Arm Description

A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.

A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 9, 2015
Last Updated
May 13, 2020
Sponsor
Mabion SA
search

1. Study Identification

Unique Protocol Identification Number
NCT02468791
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mabion SA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Autoimmune Diseases, Rituximab, Immune System Diseases, Joint Diseases, Rheumatic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
709 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MabionCD20®
Arm Type
Experimental
Arm Description
A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Arm Title
MabThera®
Arm Type
Active Comparator
Arm Description
A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Primary Outcome Measure Information:
Title
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinical Centre Banja Luka Location Paprikovac
City
Banja Luka
ZIP/Postal Code
78 000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Hospital Mostar
City
Mostar
ZIP/Postal Code
88 000
Country
Bosnia and Herzegovina
Facility Name
Clinical Centre University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71 000
Country
Bosnia and Herzegovina
Facility Name
General Hospital "Dr. Abdulah Nakas"
City
Sarajevo
ZIP/Postal Code
71 000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre Tuzla
City
Tuzla
ZIP/Postal Code
75 000
Country
Bosnia and Herzegovina
Facility Name
Carabs Medline Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Cardio-Reanimation Center Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Diagnostic Service ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
MediClub Georgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Medicore Ltd
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Medulla-Chemotherapy and Immunotherapy Clinic
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Centrum Miriada
City
Białystok
ZIP/Postal Code
15-297
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Położnicze św Łukasza Sp.z.o.o
City
Częstochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
NSZOZ Unica CR
City
Dopiewo
ZIP/Postal Code
62-069
Country
Poland
Facility Name
Wojewódzki Szpital Zespolony
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Małopolskie Centrum Medyczne S.C.
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Szpital Uniwersytecki, Oddział Kliniczny Kliniki Chorób Wewnętrznych
City
Kraków
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Szpital Specjalistyczny im. J. Dietla
City
Kraków
ZIP/Postal Code
90-119
Country
Poland
Facility Name
Ośrodek Badań Klinicznych
City
Lublin
ZIP/Postal Code
20-022
Country
Poland
Facility Name
REUMED
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED. S.C.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Centrum Medyczne Nowa Sól
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
SOLUMED
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
AL Klinika
City
Poznań
ZIP/Postal Code
61-113
Country
Poland
Facility Name
NZOZ Poradnia Leczenia Osteoporozy i Chorób Narządu Ruchu
City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
Zespół Opieki Zdrowotnej w Suchej Beskidzkiej
City
Sucha Beskidzka
ZIP/Postal Code
34-200
Country
Poland
Facility Name
Śląski Szpital Reumatologiczo-Rehabilitacyjny im. Generała Jerzego Ziętka
City
Ustroń
ZIP/Postal Code
43-450
Country
Poland
Facility Name
Medica Pro Familia Sp. z o.o. S.K.A
City
Warsaw
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Linea Corporis Spółka z Ograniczoną Odpowiedzialnością
City
Warszawa
ZIP/Postal Code
00-235
Country
Poland
Facility Name
IRMED
City
Warszawa
ZIP/Postal Code
01-157
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
01-518
Country
Poland
Facility Name
Instytut Reumatologii
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
KO-MED Centra Kliniczne
City
Zamość
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Institute for Rheumatology - Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute for treatment and rehabilitation "Niska Banja"
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Clinical center of Vojvodina, Clinic for medical rehabilitation
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Communal Medical Institution "City Clinical Hospital no 3"
City
Chernivtsi
Country
Ukraine
Facility Name
National Medical University, Chair of Internal Medicine based on Ivano-Frankivsk Central Clinical City Hospital
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Department of Cardiology and Functional Diagnostics, Kharkiv Medical Academy of Postgraduated Education
City
Kharkiv,
Country
Ukraine
Facility Name
Kharkiv City Clinical Hospital no 27
City
Kharkiv
Country
Ukraine
Facility Name
Regional Hospital Veterans of War
City
Kharkiv
Country
Ukraine
Facility Name
State Institute "L T Malaya Institute of Therapy of NAMS of Ukraine"
City
Kharkiv
Country
Ukraine
Facility Name
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
City
Kyiv
Country
Ukraine
Facility Name
National Scientific Center "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"
City
Kyiv
Country
Ukraine
Facility Name
Chair of Internal Medicine no 2 of Ternopil State Medical University
City
Ternopil
Country
Ukraine
Facility Name
Uzhgorod Clinical Hospital of the Lviv Railways, Department of Therapy
City
Uzhgorod
Country
Ukraine
Facility Name
Clinical City Hospital no 7
City
Zaporizhzhia
Country
Ukraine
Facility Name
Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine
City
Zaporizhzhia
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs