MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

May 13, 2020 updated by: Mabion SA

A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

709

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78 000
        • Clinical Centre Banja Luka Location Paprikovac
      • Mostar, Bosnia and Herzegovina, 88 000
        • University Clinical Hospital Mostar
      • Sarajevo, Bosnia and Herzegovina, 71 000
        • Clinical Centre University of Sarajevo
      • Sarajevo, Bosnia and Herzegovina, 71 000
        • General Hospital "Dr. Abdulah Nakas"
      • Tuzla, Bosnia and Herzegovina, 75 000
        • University Clinical Centre Tuzla
  • Georgia
      • Tbilisi, Georgia, 0159
        • Carabs Medline Ltd
      • Tbilisi, Georgia, 0159
        • Cardio-Reanimation Center Ltd
      • Tbilisi, Georgia, 0159
        • Diagnostic Service ltd
      • Tbilisi, Georgia, 0159
        • Tbilisi Heart and Vascular Clinic
      • Tbilisi, Georgia, 0160
        • Mediclub Georgia
      • Tbilisi, Georgia, 0186
        • Medicore Ltd
      • Tbilisi, Georgia, 0186
        • Medulla-Chemotherapy and Immunotherapy Clinic
  • Poland
      • Białystok, Poland, 15-297
        • Centrum Miriada
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
      • Częstochowa, Poland, 42-202
        • Centrum Położnicze św Łukasza Sp.z.o.o
      • Dopiewo, Poland, 62-069
        • NSZOZ Unica CR
      • Elbląg, Poland, 82-300
        • Wojewodzki Szpital Zespolony
      • Kraków, Poland, 30-510
        • Małopolskie Centrum Medyczne s.c.
      • Kraków, Poland, 31-531
        • Szpital Uniwersytecki, Oddział Kliniczny Kliniki Chorób Wewnętrznych
      • Kraków, Poland, 90-119
        • Szpital Specjalistyczny im. J. Dietla
      • Lublin, Poland, 20-022
        • Osrodek Badan Klinicznych
      • Lublin, Poland, 20-582
        • Reumed
      • Nadarzyn, Poland, 05-830
        • NZOZ Lecznica MAK-MED. S.C.
      • Nowa Sól, Poland, 67-100
        • Centrum Medyczne Nowa Sól
      • Poznań, Poland, 60-529
        • Solumed
      • Poznań, Poland, 61-113
        • AL Klinika
      • Stalowa Wola, Poland, 37-450
        • NZOZ Poradnia Leczenia Osteoporozy i Chorób Narządu Ruchu
      • Sucha Beskidzka, Poland, 34-200
        • Zespół Opieki Zdrowotnej w Suchej Beskidzkiej
      • Ustroń, Poland, 43-450
        • Śląski Szpital Reumatologiczo-Rehabilitacyjny im. Generała Jerzego Ziętka
      • Warsaw, Poland, 01-868
        • Medica Pro Familia Sp. z o.o. S.K.A
      • Warszawa, Poland, 01-518
        • Centrum Medyczne AMED
      • Warszawa, Poland, 00-235
        • Linea Corporis Spółka z Ograniczoną Odpowiedzialnością
      • Warszawa, Poland, 01-157
        • IRMED
      • Warszawa, Poland, 02-637
        • Instytut Reumatologii
      • Zamość, Poland, 22-400
        • KO-MED Centra Kliniczne
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Rheumatology - Belgrade
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Niska Banja, Serbia, 18205
        • Institute for treatment and rehabilitation "Niska Banja"
      • Novi Sad, Serbia, 21000
        • Clinical center of Vojvodina, Clinic for medical rehabilitation
  • Ukraine
      • Chernivtsi, Ukraine
        • Communal Medical Institution "City Clinical Hospital no 3"
      • Ivano-Frankivsk, Ukraine
        • National Medical University, Chair of Internal Medicine based on Ivano-Frankivsk Central Clinical City Hospital
      • 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
        • Department of Cardiology and Functional Diagnostics, Kharkiv Medical Academy of Postgraduated Education
      • Kyiv, 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"
      • Ternopil, Ukraine
        • Chair of Internal Medicine no 2 of Ternopil State Medical University
      • Uzhgorod, Ukraine
        • Uzhgorod Clinical Hospital of the Lviv Railways, Department of Therapy
      • Zaporizhzhia, Ukraine
        • Clinical City Hospital no 7
      • Zaporizhzhia, Ukraine
        • Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MabionCD20®
A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Drug: Rituximab
Active Comparator: MabThera®
A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
Drug: Rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabion SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MabionCD20-001RA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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