Rheumatoid ArthritisPhase 3ALTERRANCT02744196
Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis
A Phase 3 study testing Acellbia and Methotrexate in people with Rheumatoid Arthritis, run by Biocad.
Trial summary
The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate. 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?
- Acellbia and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 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
- Written informed consent. Age from 18 to 80 years. Rheumatoid arthritis diagnosed at least 6 months before informed consent signing Presence of more than 8 swollen and more than 8 painful joints at screening. C-reactive protein 7 mg/l or more AND/OR erythrocyte sedimentation rate 28 mm/hour or more.
- Antibodies to citrullinated cyclic peptide 20 U/ml or more AND/OR rheumatoid factor-IgM higher than upper normal limit.
- Documented regular methotrexate intake for 12 weeks, stable dose from 10 to 25 mg/week during last 4 weeks before signing informed consent.
Who cannot join
- Methotrexate intolerance. Felty's syndrome. Patient functional status - IV class according to ACR. Previous use of biologic drugs to treat rheumatoid arthritis, biologic drugs that deplete CD20-lymphocytes, azathioprine use in the last 28 days prior to informed consent signing, leflunomide use in the last 8 weeks prior to informed consent signing, sulphasalazine/hydroxyquinoline use in the last 28 days prior to informed consent signing, intraarticular use of corticosteroids in the last 4 weeks prior to informed consent signing, patient requires prednisolone (or analogues) in a dose more than 10 mg/day or dose is unstable during 4 weeks prior to informed consent signing, requirement in non-steroid antiinflammatory drugs if their dose was not stable during last 8 weeks prior to informed consent signing.
- Patient has inflammatory joint disease otherwise than rheumatoid arthritis or systemic autoimmune diseases.
- Full list of inclusion and exclusion criteria can be found in Study Protocol.
About this study
Official title: Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis
The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Acellbia, Placebo, Methotrexate
- Keywords
- rheumatoid arthritis, rheumatism, Acellbia, methotrexate, biologic therapy, monoclonal antibody, rituximab
- Medical subject headings
- Arthritis, Rheumatoid, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcellbiaBiological
Also called rituximab
Acellbia is rituximab biosimilar, monoclonal antibody which binds CD20.
PlaceboDrug
Placebo solution will look identical to the Acellbia solution.
MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| Acellbia + methotrexate | Experimental | 106 patients of this group will receive methotrexate in combination with a drug Acellbia to be used at a dose of 600 mg as a slow intravenous infusion carried out on day 1 and day 15.
If a follow-up examination at 24 weeks or later (up to 48 weeks) reveals that the patient still has active arthritis (evaluation index DAS28-4 (ESR)> 2,6 points), the therapy with Acellbia is repeated by the same scheme - 2 infusion at a dose of 600 mg at intervals of 14 days. Receives: Biological: Acellbia; Drug: Methotrexate |
| Placebo + methotrexate | Placebo comparator | 53 patients of this group will receive methotrexate in combination with a placebo to be used as a slow intravenous infusion carried out on day 1 and day 15.
If a follow-up examination at 24 weeks or later (up to 48 weeks) reveals that the patient still has active arthritis (evaluation index DAS28-4 (ESR)> 2,6 points), the patient receives open therapy with Acellbia is initiated: 2 infusion at a dose of 600 mg at intervals of 14 days. Receives: Biological: Acellbia; Drug: Placebo; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who developed ACR20 response on 24 week of therapy
The proportion of patients achieving at least a 20% improvement in ACR criteria at 24 weeks of therapy.
Measured: Week 24
Secondary outcomes (19)
Percentage of patients who developed ACR50 and ACR70 response on 24 week of therapy
The proportion of patients achieving at least 50% and 70% improvement in ACR criteria at 24 weeks of therapy.
Measured: Week 24
Percentage of patients who developed ACR20, ACR50 and ACR70 response on 16 week of therapy
The proportion of patients achieving at least 20%, 50% and 70% improvement in ACR criteria after 16 weeks of therapy.
Measured: Week 16
Change in average DAS28-4 (ESR) score after 24 weeks of therapy
Change in average DAS28-4 (ESR) score after 24 weeks of therapy
Measured: Week 24
Change in average HAQ-DI score after 24 weeks of therapy
Measured: Week 24
Change in average score according to modified Sharp method of assessment after 24 weeks of therapy
Measured: Week 24
Change in average score of erosions according to modified Sharp method of assessment after 24 weeks of therapy
Measured: Week 24
Change in average score of joint spase narrowing according to modified Sharp method of assessment after 24 weeks of therapy
Measured: Week 24
Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 24 weeks of treatment
Measured: Week 24
Percentage of patients who developed ACR20, ACR50 and ACR70 response on 52 week of therapy
The proportion of patients achieving at least 20%, 50% and 70% improvement in ACR criteria after 52 weeks of therapy.
Measured: Week 52
Change in average DAS28-4 (ESR) score after 52 weeks of therapy
Change in average DAS28-4 (ESR) score after 52 weeks of therapy
Measured: Week 52
Change in average HAQ-DI score after 52 weeks of therapy
Measured: Week 52
Change in average score according to modified Sharp method of assessment after 52 weeks of therapy
Measured: Week 52
Change in average score of erosions according to modified Sharp method of assessment after 52 weeks of therapy
Measured: Week 52
Change in average score of joint space narrowing according to modified Sharp method of assessment after 52 weeks of therapy
Measured: Week 52
Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 52 weeks of treatment
Measured: Week 52
Frequency and severity of AE/SAE
Frequency and severity of AE/SAE in patients who received at least one injection of study drug/placebo
Measured: 52 weeks
Frequency of AE 3-4 grade CTCAE 4.03
Frequency of AE 3-4 grade CTCAE 4.03 in patients who received at least one injection of study drug/placebo
Measured: 52 weeks
Frequency of premature withdrawal due to AE/SAE
Measured: 52 weeks
Percentage of patients who have developed binding and neutralizing antibodies to rituximab on week 24 and week 52
Measured: Week 24, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2017
- Study completionAug 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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, PhD, Study chair, JCS BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744196
- Sponsor's protocol ID
- BCD-020-4
- Acronym
- ALTERRA
- Status last verified
- Jan 2018
- First submitted
- 4 Apr 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02744196
- Acronym / sponsor ID
- ALTERRA / BCD-020-4
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, rheumatism, Acellbia, methotrexate, biologic therapy, monoclonal antibody, rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Apr 2016 (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 mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acellbia + methotrexate | Experimental | Biological: Acellbia, Drug: Methotrexate106 patients of this group will receive methotrexate in combination with a drug Acellbia to be used at a dose of 600 mg as a slow intravenous infusion carried out on day 1 and day 15. If a follow-up examination at 24 weeks or later (up to 48 weeks) reveals that the patient still has active arthritis (evaluation index DAS28-4 (ESR)> 2,6 points), the therapy with Acellbia is repeated by the same scheme - 2 infusion at a dose of 600 mg at intervals of 14 days. |
| Placebo + methotrexate | Placebo comparator | Biological: Acellbia, Drug: Placebo, Drug: Methotrexate53 patients of this group will receive methotrexate in combination with a placebo to be used as a slow intravenous infusion carried out on day 1 and day 15. If a follow-up examination at 24 weeks or later (up to 48 weeks) reveals that the patient still has active arthritis (evaluation index DAS28-4 (ESR)> 2,6 points), the patient receives open therapy with Acellbia is initiated: 2 infusion at a dose of 600 mg at intervals of 14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent. Age from 18 to 80 years. Rheumatoid arthritis diagnosed at least 6 months before informed consent signing Presence of more than 8 swollen and more than 8 painful joints at screening. C-reactive protein 7 mg/l or more AND/OR erythrocyte sedimentation rate 28 mm/hour or more.
- Antibodies to citrullinated cyclic peptide 20 U/ml or more AND/OR rheumatoid factor-IgM higher than upper normal limit.
- Documented regular methotrexate intake for 12 weeks, stable dose from 10 to 25 mg/week during last 4 weeks before signing informed consent.
Key exclusion criteria (3 listed)
- Methotrexate intolerance. Felty's syndrome. Patient functional status - IV class according to ACR. Previous use of biologic drugs to treat rheumatoid arthritis, biologic drugs that deplete CD20-lymphocytes, azathioprine use in the last 28 days prior to informed consent signing, leflunomide use in the last 8 weeks prior to informed consent signing, sulphasalazine/hydroxyquinoline use in the last 28 days prior to informed consent signing, intraarticular use of corticosteroids in the last 4 weeks prior to informed consent signing, patient requires prednisolone (or analogues) in a dose more than 10 mg/day or dose is unstable during 4 weeks prior to informed consent signing, requirement in non-steroid antiinflammatory drugs if their dose was not stable during last 8 weeks prior to informed consent signing.
- Patient has inflammatory joint disease otherwise than rheumatoid arthritis or systemic autoimmune diseases.
- Full list of inclusion and exclusion criteria can be found in Study Protocol.
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 |
|---|---|---|
| AcellbiaAlso: rituximabAcellbia is rituximab biosimilar, monoclonal antibody which binds CD20. | Biological | Acellbia + methotrexate, Placebo + methotrexate |
| PlaceboPlacebo solution will look identical to the Acellbia solution. | Drug | Placebo + methotrexate |
| Methotrexate | Drug | Acellbia + methotrexate, Placebo + methotrexate |
Primary outcome
Percentage of patients who developed ACR20 response on 24 week of therapy
Time frame: Week 24
The proportion of patients achieving at least a 20% improvement in ACR criteria at 24 weeks of therapy.
19 secondary outcomes
Percentage of patients who developed ACR50 and ACR70 response on 24 week of therapy
Time frame: Week 24
Percentage of patients who developed ACR20, ACR50 and ACR70 response on 16 week of therapy
Time frame: Week 16
Change in average DAS28-4 (ESR) score after 24 weeks of therapy
Time frame: Week 24
Change in average HAQ-DI score after 24 weeks of therapy
Time frame: Week 24
Change in average score according to modified Sharp method of assessment after 24 weeks of therapy
Time frame: Week 24
Change in average score of erosions according to modified Sharp method of assessment after 24 weeks of therapy
Time frame: Week 24
Change in average score of joint spase narrowing according to modified Sharp method of assessment after 24 weeks of therapy
Time frame: Week 24
Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 24 weeks of treatment
Time frame: Week 24
Percentage of patients who developed ACR20, ACR50 and ACR70 response on 52 week of therapy
Time frame: Week 52
Change in average DAS28-4 (ESR) score after 52 weeks of therapy
Time frame: Week 52
Change in average HAQ-DI score after 52 weeks of therapy
Time frame: Week 52
Change in average score according to modified Sharp method of assessment after 52 weeks of therapy
Time frame: Week 52
Change in average score of erosions according to modified Sharp method of assessment after 52 weeks of therapy
Time frame: Week 52
Change in average score of joint space narrowing according to modified Sharp method of assessment after 52 weeks of therapy
Time frame: Week 52
Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 52 weeks of treatment
Time frame: Week 52
Frequency and severity of AE/SAE
Time frame: 52 weeks
Frequency of AE 3-4 grade CTCAE 4.03
Time frame: 52 weeks
Frequency of premature withdrawal due to AE/SAE
Time frame: 52 weeks
Percentage of patients who have developed binding and neutralizing antibodies to rituximab on week 24 and week 52
Time frame: Week 24, Week 52
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 25 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Roman Ivanov, PhD study chair
JCS BIOCAD
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acellbia and Methotrexate in people with Rheumatoid Arthritis, run by Biocad.
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 3 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 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 who developed ACR20 response on 24 week of therapy (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 25 Jan 2018.