Rheumatoid ArthritisPhase 3BIORANCT01759030
Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis
A Phase 3 study testing Rituximab in people with Rheumatoid Arthritis, run by Biocad at 40 sites in 4 countries.
Trial summary
The purpose of this study is to prove that efficacy, safety and immunogenicity of BCD-020 is equivalent to MabThera when used in combination with methotrexate for the treatment of patient with 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
- 181 participants
- Where
- 40 sitesin 4 countries
- Study dates
- Dec 2012to Jul 2015
- 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
- Having signed a written informed consent form.
- Patients must be from 18 to 80 years of age (both ages inclusive)
- Rheumatoid arthritis confirmed according to ACR 1987 criteria.
- Seropositive rheumatoid arthritis.
- Active rheumatoid arthritis during the last 3 months.
- Disease score according to DAS28 of 3.2 or more, TJC≥8 (68), SJC≥8 (66), hsCRP≥6 mg/l, ESR≥28 mm/hr (by Westergren) at the moment of screening.
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- Patient's functional status - class I-III according to ACR classification
- Inadequate response to DMARDs that include one or more TNF inhibitors, intolerance or contraindications to TNF inhibitors.
- Necessity of methotrexate treatment during the last 4 weeks prior to screening period with stable/consistent dosage of 7.5 - 20 mg per week.
- Patient's ability (in Investigator's opinion) to follow the protocol procedures;
- Willingness to use contraception during all study period.
Who cannot join
- Patients with Felty's syndrome (irrespectively to clinical form).
- Patient's functional status - class IV according to ACR classification .
- Rheumatoid arthritis low activity (less than 3.2 according to DAS28).
- Concomitant therapy:
- Previous treatment with any biological drug products causing CD20+ lymphocyte depletion, including biological investigational drugs.
- Treatment with azathioprine within 28 days before the study initiation and with leflunomide within 8 weeks before the study's principal phase (treatment with rituximab).
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- Intra-articular glucocorticosteroids within 4 weeks before the study's principal phase (treatment with rituximab).
- Necessity for prednisone or its equivalent administration at dose more than 10 mg per day.
- Necessity for prednisone or its equivalent administration at dose ≤10 mg per day in cases when this dose wasn't stable/consistent during last 4 weeks.
- Necessity for administration of non-steroidal anti-inflammatory drugs for arthritis treatment in cases when its doses were not stable/consistent during last 4 weeks.
- Pregnancy and breast-feeding.
- Changes of laboratory values:
- Hemoglobin level is less than 100 g/l;
- Leucocyte level is less than 3,0×10e9/l;
- Absolute neutrophil count is less than 1,5×10e9/l;
- Thrombocyte level is less than 100×10e9/l.
- Confirmed chicken pox within 30 days before inclusion to the screening.
- Confirmed herpes zoster infection.
- Acute forms of any infectious diseases, history of chronic infections with severe clinical manifestations.
- Active tuberculosis, history of latent tuberculosis.
- Inflammatory disease of the joints (present or in anamnesis) not related to rheumatoid arthritis (including gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease and others) or other systemic autoimmune disease (including systemic lupus erythematosus, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed forms of connective tissue inflammatory diseases, cross-syndrome and others).
- Juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis developed before the age of 16.
- Any determined immunodeficiency.
- Pernicious anemia.
- Confirmed cobalamine deficiency.
- Other somatic diseases (apart from rheumatoid arthritis) that can increase the probability of adverse events during the study or can influence the estimation of symptom manifestation of RA ; mask, enhance or alter the symptoms of RA or cause clinical or laboratory symptoms similar to that of RA;
- Positive results of serological test of Hepatitis B surface antigen (HbsAg) or presence of Hbc IgM together with positive results of HBV PCR test, presence of antibodies to Hepatitis C virus, syphilis or HIV.
- Major surgery within 28 days prior to the trial principal phase (treatment with rituximab).
- Any mental disorder, including major depression and/or suicidal thoughts in anamnesis that can, in Investigator's opinion, create a risk for the patient or influence the patient's ability to follow the study protocol.
- Unstable angina pectoris.
- Myocardial infarction within less than 1 year prior to participation in the study.
- Severe central or peripheral nervous system diseases.
- Drug addiction, alcoholism.
- Known hypersensitivity to murine proteins or any other components of the medications used in the treatment, methotrexate, folic acid and any drugs used in premedication.
- Presence of malignant neoplasm, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ and any malignancy with complete remission of more than 5 years;
- Simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation; previous participation in this study.
Trial locations and contacts
40 sites in 4 countries.
40 sites in 4 countries
India23 sites
Satellite Orthopaedic Hospital & Research Centre Pvt Ltd
Ahmadābād
Smt NHL Medical College and SethVS General Hospital
Ahmadābād
Bangalore Medical College and Research Institute, Victoria Hospital
Bangalore
Pristine Hospital and Research Center Pvt. Ltd
Bangalore
Sapthagiri Institute of Medical Sciences and Research Centre#15
Bangalore
Sri Venkateshwara Hospital
Bangalore
Sri Ramachandra Medical Centre, No.1
Chennai
Government Medical College and Hospital Panchakki Road
Chhatrapati Sambhajinagar
Swami Vivekananda National Institrute of Rehabilitation Training and research
Cuttack
Gandhi Hospital, Department of Orthopedics
Hyderabad
Sri Sri Holistic Hospitals
Hyderabad
Sumana Hospitals, Research Department
Hyderabad
Yashoda Hospital
Hyderabad
Jaipur Hospital, Lal Kothi, Near SMS Stadium
Jaipur
SMS Medical College & Hospital
Jaipur
Calcutta national medical college, Kolkata
Kolkata
Bhatia Hospital, Medical Research Society
Mumbai
Government Medical College and Hospital
Nagpur
Jawarlal Institute of Postgraduation Medical Education and Research
Puducherry
B.J Medical college Sassoon General Hospital, Near Pune Railway Station
Pune
Medipoint Hospitals Pvt Ltd
Pune
Ruby Hall Clinic
Pune
Christian Medical College
Vellore
Russia10 sites
Chelyabinsk Regional Clinical hospital
Chelyabinsk
Clinical Hospital at Chelyabinsk Railway Station
Chelyabinsk
Kursk regional hospital
Kursk
Research Institute of Rheumotology
Moscow
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
N.Novgorod
Limited liability company Consultation and Diagnostic Center "Zdorovyye sustavy"
Novosibirsk
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg
Local hospital at the station Smolensk OAO RZD
Smolensk
Smolensk State Medical Academy
Smolensk
Novgorod regional clinical hospital
Velikiy Novgorod
Belarus4 sites
Gomel Regional Clinical Hospital
Homyel
City Clinical Hospital №1
Minsk
City Clinical Hospital №9
Minsk
Vitebsk Regional Clinical Hospital
Vitebsk
Ukraine3 sites
Kharkiv City Clinical Emergency Hospital n.a. O.I.Meschaninov
Kharkiv
National Research Center "Cardiology Institute n.a. M.D.Strazheska"
Kyiv
Odessa Regional Cardiology Dispensary
Odesa
About this study
Official title: Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies
The purpose of this study is to prove that efficacy, safety and immunogenicity of BCD-020 is equivalent to MabThera when used in combination with methotrexate for the treatment of patient with rheumatoid arthritis
Read the detailed description
This is an international multicenter double-blind randomized clinical study of the efficacy and safety (Phase III) with an active comparator; the study provides the additional evaluation of the interchangeability of rituximab biosimilar and original product MabThera.
The study will include 308 subjects with active seropositive rheumatoid arthritis who had intolerance or inadequate response to current therapy regimens including one or more TNF inhibitors, or who had contraindications to TNF inhibitors.
The first 24-week stage includes one course of rituximab therapy. The first study stage proposes central randomization into 2 large groups (1:1): patients from the first group will recieve BCD-020 (rituximab manufactured by CJSC BIOCAD) at a dose 1000 mg in a drop-wise manner on day 1 and day 15; patients from the second group will recieve MabThera at a same regimen.
On the final visit of Stage 1 (visit 11 at week 24) all efficacy parameters must be evaluated. If the disease activity remains (DAS28 score ≥2.6 or increased by 0.6 points or more compared to the last measurement) the patient will recieve another course of rituximab treatment. In this case a partial crossover (Stage 2) will take place (by means of the second randomization): one half of patients with active RA, previously treated with BCD-020, will receive MabThera at a dose 1000 mg on day 1 and day 15; and one half of patients with active RA, previously treated with MabThera, will receive BCD-020 at a dose 1000 mg ion day 1 and day 15. After the first rituximab infusion performed for retreatment, the patient will undergo 24-week follow-up (counted starting from the date of retreatment initiation). Thus, effects of the switch from BCD-020 to MabThera and vice versa will be assessed in 24 weeks after the crossover (Stage 2 of the study).
Patients in whom remission of RA (DAS28 < 2.6) is reported on week 24 counting from the initial randomization will undergo the follow up for the next 24 weeks. During this period they will attend 3 visits (weeks 32, 40 and 48) in order to monitor the disease. If the exacerbation occurs within the time period not corresponding to week 32 or week 40, the patient will be invited to the study site for an out-of-schedule visit. If disease exacerbation is confirmed, he/she undergoes the second randomization, second rituximab treatment course and further follow up for 6 months (as described above).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rituximab
- Keywords
- rheumatoid arthritis, DMARDs, rituximab, biosimilar, interchangeability
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called MabThera, Rituxan, BCD-020
Patients will will receive rituximab a dose of 1000 mg , intravenously, slowly, once in 2 weeks, with 2 infusions per course (on day 1 and day 15).
| Study group | Role | What they receive |
|---|---|---|
| MabThera (F. Hoffmann-La Roche Ltd.) | Active comparator | Stage 1 (week 1 - week 24) MabThera will be administered at a dose of 1000 mg, IV (on day 1 and day 15).
Stage 2 (week 24 - 48) If the disease activity remains on Week 24 the patient will undergo the second randomization (1:1 ratio): if he/she randomised into group A then he/she recieves BCD-020 at a dose f 1000 mg, IV, once in 2 weeks, 2 infusions per course (on day 1 and day 15); if he/she if he/she randomised into group B then he/she continues to recieve MabThera at a dose f 1000 mg, IV, once in 2 weeks, 2 infusions per course (on day 1 and day 15).
MabThera/BCD-020 will be used in combination with methotrexate (irrespectively to study stage). Receives: Drug: Rituximab |
| BCD-020 (CJSC BIOCAD) | Experimental | Stage 1 (week 1-week 24) BCD-020 will be administered at a dose of 1000 mg, IV (on day 1 and day 15).
Stage 2 (week 24-48) If the disease activity remains on Week 24 the patient will undergo the second randomization (1:1 ratio): if he/she randomised into group A then he/she recieves MabThera at a dose f 1000 mg, IV, on day 1 and day 15; if he/she if he/she randomised into group B then he/she continues to recieve BCD-020 at a dose f 1000 mg, IV, on day 1 and day 15.
MabThera/BCD-020 will be used in combination with methotrexate (irrespectively to study stage). Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who have reached ACR20 within 24 weeks after the treatment initiation
Measured: week 24
Secondary outcomes (5)
Frequency of adverse events (AE) and serious adverse events (SAE) that is related, in Investigator's opinion, to rheumatoid arthritis therapy
Measured: during all time of participation in the study
Frequency of AE and SAE grade 3-4 that is related, in Investigator's opinion, to rheumatoid arthritis therapy
Measured: during all time of participation in the study
Number of cases of early withdrawal from the study caused by AE or SAE
Measured: during all time of participation in the study
Level of binding and neutralizing antibodies to rituximab in patients from both groups
Measured: at screening, week 12, week 24
CD19+ and CD20+ lymphocyte counts
Measured: before infusion, after the 1st and the 2nd infusion of rituximab, on day 3,17,29 after the 1st infusion, at week 12,24,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2015
- Study completionJul 2015
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.
- More trials run by BiocadThe sponsor's other registered studies.
- 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759030
- Sponsor's protocol ID
- BIORA (BCD-020-2)
- Acronym
- BIORA
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2012
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies
- ClinicalTrials.gov ID
- NCT01759030
- Acronym / sponsor ID
- BIORA / BIORA (BCD-020-2)
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, DMARDs, rituximab, biosimilar, interchangeability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Jan 2013 (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 prove that efficacy, safety and immunogenicity of BCD-020 is equivalent to MabThera when used in combination with methotrexate for the treatment of patient with rheumatoid arthritis
Detailed description
This is an international multicenter double-blind randomized clinical study of the efficacy and safety (Phase III) with an active comparator; the study provides the additional evaluation of the interchangeability of rituximab biosimilar and original product MabThera.
The study will include 308 subjects with active seropositive rheumatoid arthritis who had intolerance or inadequate response to current therapy regimens including one or more TNF inhibitors, or who had contraindications to TNF inhibitors.
The first 24-week stage includes one course of rituximab therapy. The first study stage proposes central randomization into 2 large groups (1:1): patients from the first group will recieve BCD-020 (rituximab manufactured by CJSC BIOCAD) at a dose 1000 mg in a drop-wise manner on day 1 and day 15; patients from the second group will recieve MabThera at a same regimen.
On the final visit of Stage 1 (visit 11 at week 24) all efficacy parameters must be evaluated. If the disease activity remains (DAS28 score ≥2.6 or increased by 0.6 points or more compared to the last measurement) the patient will recieve another course of rituximab treatment. In this case a partial crossover (Stage 2) will take place (by means of the second randomization): one half of patients with active RA, previously treated with BCD-020, will receive MabThera at a dose 1000 mg on day 1 and day 15; and one half of patients with active RA, previously treated with MabThera, will receive BCD-020 at a dose 1000 mg ion day 1 and day 15. After the first rituximab infusion performed for retreatment, the patient will undergo 24-week follow-up (counted starting from the date of retreatment initiation). Thus, effects of the switch from BCD-020 to MabThera and vice versa will be assessed in 24 weeks after the crossover (Stage 2 of the study).
Patients in whom remission of RA (DAS28 < 2.6) is reported on week 24 counting from the initial randomization will undergo the follow up for the next 24 weeks. During this period they will attend 3 visits (weeks 32, 40 and 48) in order to monitor the disease. If the exacerbation occurs within the time period not corresponding to week 32 or week 40, the patient will be invited to the study site for an out-of-schedule visit. If disease exacerbation is confirmed, he/she undergoes the second randomization, second rituximab treatment course and further follow up for 6 months (as described above).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MabThera (F. Hoffmann-La Roche Ltd.) | Active comparator | Drug: RituximabStage 1 (week 1 - week 24) MabThera will be administered at a dose of 1000 mg, IV (on day 1 and day 15). Stage 2 (week 24 - 48) If the disease activity remains on Week 24 the patient will undergo the second randomization (1:1 ratio): if he/she randomised into group A then he/she recieves BCD-020 at a dose f 1000 mg, IV, once in 2 weeks, 2 infusions per course (on day 1 and day 15); if he/she if he/she randomised into group B then he/she continues to recieve MabThera at a dose f 1000 mg, IV, once in 2 weeks, 2 infusions per course (on day 1 and day 15). MabThera/BCD-020 will be used in combination with methotrexate (irrespectively to study stage). |
| BCD-020 (CJSC BIOCAD) | Experimental | Drug: RituximabStage 1 (week 1-week 24) BCD-020 will be administered at a dose of 1000 mg, IV (on day 1 and day 15). Stage 2 (week 24-48) If the disease activity remains on Week 24 the patient will undergo the second randomization (1:1 ratio): if he/she randomised into group A then he/she recieves MabThera at a dose f 1000 mg, IV, on day 1 and day 15; if he/she if he/she randomised into group B then he/she continues to recieve BCD-020 at a dose f 1000 mg, IV, on day 1 and day 15. MabThera/BCD-020 will be used in combination with methotrexate (irrespectively to study stage). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Having signed a written informed consent form.
- Patients must be from 18 to 80 years of age (both ages inclusive)
- Rheumatoid arthritis confirmed according to ACR 1987 criteria.
- Seropositive rheumatoid arthritis.
- Active rheumatoid arthritis during the last 3 months.
Key exclusion criteria (36 listed)
- Patients with Felty's syndrome (irrespectively to clinical form).
- Patient's functional status - class IV according to ACR classification .
- Rheumatoid arthritis low activity (less than 3.2 according to DAS28).
- Concomitant therapy:
- Pregnancy and breast-feeding.
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 |
|---|---|---|
| RituximabAlso: MabThera, Rituxan, BCD-020Patients will will receive rituximab a dose of 1000 mg , intravenously, slowly, once in 2 weeks, with 2 infusions per course (on day 1 and day 15). | Drug | BCD-020 (CJSC BIOCAD), MabThera (F. Hoffmann-La Roche Ltd.) |
Primary outcome
Number of patients who have reached ACR20 within 24 weeks after the treatment initiation
Time frame: week 24
5 secondary outcomes
Frequency of adverse events (AE) and serious adverse events (SAE) that is related, in Investigator's opinion, to rheumatoid arthritis therapy
Time frame: during all time of participation in the study
Frequency of AE and SAE grade 3-4 that is related, in Investigator's opinion, to rheumatoid arthritis therapy
Time frame: during all time of participation in the study
Number of cases of early withdrawal from the study caused by AE or SAE
Time frame: during all time of participation in the study
Level of binding and neutralizing antibodies to rituximab in patients from both groups
Time frame: at screening, week 12, week 24
CD19+ and CD20+ lymphocyte counts
Time frame: before infusion, after the 1st and the 2nd infusion of rituximab, on day 3,17,29 after the 1st infusion, at week 12,24,48
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 27 Mar 2017.
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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.
40 sites in 4 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 Biocad at 40 sites in 4 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 11 inclusion and 36 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in India, Russia, Belarus, Ukraine. 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?
Number of patients who have reached ACR20 within 24 weeks after the treatment initiation (time frame: week 24). 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 27 Mar 2017.