Rheumatoid ArthritisPhase 3NCT02468791
MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
A Phase 3 study testing Rituximab in people with Rheumatoid Arthritis, run by Mabion SA at 51 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 709 participants
- Where
- 51 sitesin 5 countries
- Study dates
- May 2013to Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 5 countries.
51 sites in 5 countries
Poland23 sites
Centrum Miriada
Bialystok, 15-297
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Centrum Położnicze św Łukasza Sp.z.o.o
Częstochowa, 42-202
NSZOZ Unica CR
Dopiewo, 62-069
Wojewódzki Szpital Zespolony
Elblag, 82-300
Małopolskie Centrum Medyczne S.C.
Krakow, 30-510
Szpital Uniwersytecki, Oddział Kliniczny Kliniki Chorób Wewnętrznych
Krakow, 31-531
Szpital Specjalistyczny im. J. Dietla
Krakow, 90-119
Ośrodek Badań Klinicznych
Lublin, 20-022
REUMED
Lublin, 20-582
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, 05-830
Centrum Medyczne Nowa Sól
Nowa Sól, 67-100
SOLUMED
Poznan, 60-529
AL Klinika
Poznan, 61-113
NZOZ Poradnia Leczenia Osteoporozy i Chorób Narządu Ruchu
Stalowa Wola, 37-450
Zespół Opieki Zdrowotnej w Suchej Beskidzkiej
Sucha Beskidzka, 34-200
Śląski Szpital Reumatologiczo-Rehabilitacyjny im. Generała Jerzego Ziętka
Ustroń, 43-450
Linea Corporis Spółka z Ograniczoną Odpowiedzialnością
Warsaw, 00-235
IRMED
Warsaw, 01-157
Centrum Medyczne AMED
Warsaw, 01-518
Medica Pro Familia Sp. z o.o. S.K.A
Warsaw, 01-868
Instytut Reumatologii
Warsaw, 02-637
KO-MED Centra Kliniczne
Zamość, 22-400
Ukraine12 sites
Communal Medical Institution "City Clinical Hospital no 3"
Chernivtsi
National Medical University, Chair of Internal Medicine based on Ivano-Frankivsk Central Clinical City Hospital
Ivano-Frankivsk
Department of Cardiology and Functional Diagnostics, Kharkiv Medical Academy of Postgraduated Education
Kharkiv
Kharkiv City Clinical Hospital no 27
Kharkiv
Regional Hospital Veterans of War
Kharkiv
State Institute "L T Malaya Institute of Therapy of NAMS of Ukraine"
Kharkiv
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
Kyiv
National Scientific Center "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"
Kyiv
Chair of Internal Medicine no 2 of Ternopil State Medical University
Ternopil
Uzhgorod Clinical Hospital of the Lviv Railways, Department of Therapy
Uzhhorod
Clinical City Hospital no 7
Zaporizhzhya
Zaporizhzhia Medical Academy of Postgraduate Education of Ministry of Health of Ukraine
Zaporizhzhya
Georgia7 sites
Carabs Medline Ltd
Tbilisi, 0159
Cardio-Reanimation Center Ltd
Tbilisi, 0159
Diagnostic Service ltd
Tbilisi, 0159
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
MediClub Georgia
Tbilisi, 0160
Medicore Ltd
Tbilisi, 0186
Medulla-Chemotherapy and Immunotherapy Clinic
Tbilisi, 0186
Bosnia and Herzegovina5 sites
Clinical Centre Banja Luka Location Paprikovac
Banja Luka, 78 000
University Clinical Hospital Mostar
Mostar, 88 000
Clinical Centre University of Sarajevo
Sarajevo, 71 000
General Hospital "Dr. Abdulah Nakas"
Sarajevo, 71 000
University Clinical Centre Tuzla
Tuzla, 75 000
Serbia4 sites
Institute for Rheumatology - Belgrade
Belgrade, 11000
Clinical Center Kragujevac
Kragujevac, 34000
Institute for treatment and rehabilitation "Niska Banja"
Niška Banja, 18205
Clinical center of Vojvodina, Clinic for medical rehabilitation
Novi Sad, 21000
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rituximab
- Keywords
- Rheumatoid Arthritis, Autoimmune Diseases, Rituximab, Immune System Diseases, Joint Diseases, Rheumatic Diseases
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases, Immune System Diseases, Joint Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| MabionCD20® | Experimental | A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval. Receives: Drug: Rituximab |
| MabThera® | Active comparator | A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startMay 2013
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mabion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468791
- Sponsor's protocol ID
- MabionCD20-001RA
- Status last verified
- May 2020
- First submitted
- 9 Jun 2015
- Last updated
- 14 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02468791
- Acronym / sponsor ID
- MabionCD20-001RA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Autoimmune Diseases, Rituximab, Immune System Diseases, Joint Diseases, Rheumatic Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- Mabion SAIndustry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MabionCD20® | Experimental | Drug: RituximabA course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval. |
| MabThera® | Active comparator | Drug: RituximabA course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab | Drug | MabThera®, MabionCD20® |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab in people with Rheumatoid Arthritis, run by Mabion SA at 51 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Poland, Ukraine, Georgia, Bosnia and Herzegovina, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.