Ankylosing SpondylitisPhase 3NCT02762812
Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
A Phase 3 study testing BCD-055 and Remicade® in people with Ankylosing Spondylitis, run by Biocad at 1 site in Russia.
Trial summary
BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis. BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- BCD-055 and Remicade®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2016to Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening.
- Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening.
- Mean backache intensity equals 4 points or more.
Who cannot join
- Previous therapy of ankylosing spondylitis with monoclonal antibodies (including tumor necrosis factor)
- Total spinal ankylosis
- History of tuberculosis
- Body mass more than 120 kg
- Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
- Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization.
Show all 9Show fewer
- Prior use of alkylating agents for up to 12 months prior to signing informed consent.
- Intraarticular use of corticosteroids for up to 4 weeks before randomization.
- Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg
About this study
Official title: International Multi-center Comparative Double-blind Randomized Clinical Trial to Evaluate Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Patients With Ankylosing Spondylitis
BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis.
BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia)
- Conditions
- Ankylosing Spondylitis
- Being tested
- BCD-055, Remicade®
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-055Biological
Also called infliximab
Remicade®Biological
Also called infliximab
| Study group | Role | What they receive |
|---|---|---|
| BCD-055 | Experimental | Patients in this group will receive BCD-055 in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54. Receives: Biological: BCD-055 |
| Remicade® | Active comparator | Patients in this group will receive Remicade® in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54. Receives: Biological: Remicade® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of patients with ASAS20 response after 30 weeks of therapy
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 30 weeks of therapy with BCD-055.
Measured: Week 30
Secondary outcomes (11)
Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 14 and 54 weeks of therapy with BCD-055.
Measured: Week 14, Week 54
Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more after 14, 30 and 54 weeks of therapy with BCD-055.
Measured: Week 14, Week 30, Week 54
Mean change in BASDAI after 14, 30 and 54 weeks of therapy
Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) after 14, 30 and 54 weeks of therapy
Measured: Week 14, Week 30, Week 54
Mean change in BASMI after 14, 30 and 54 weeks of therapy
Mean change in Bath Ankylosing Spondylitis Metrology Index (BASMI), after 14, 30 and 54 weeks of therapy
Measured: Week 14, Week 30, Week 54
Mean change in BASFI after 14, 30 and 54 weeks of therapy
Mean change in Bath Ankylosing Spondylitis Functional Index (BASFI) after 14, 30 and 54 weeks of therapy
Measured: Week 14, Week 30, Week 54
Mean change in MASES after 14, 30 and 54 weeks of therapy
Mean change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) after 14, 30 and 54 weeks of therapy
Measured: Week 14, Week 30, Week 54
Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy
Mean score of quality of life as assessed by Short Form-36 (SF-36) at screening and after 14, 30 and 54 weeks of therapy
Measured: Week 14, Week 30, Week 54
Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy
Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy
Measured: Week 14, Week 30, Week 54
Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
Measured: Week 14, Week 30, Week 54
Frequency of AE/SAE
Frequency of AE/SAE
Measured: 54 weeks
Frequency of AE 3-4 grade CTCAE
Frequency of AE 3-4 grade CTCAE
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- 199 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
- NCT02762812
- Sponsor's protocol ID
- BCD-055-2
- Status last verified
- Feb 2018
- First submitted
- 4 Apr 2016
- Last updated
- 23 Feb 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multi-center Comparative Double-blind Randomized Clinical Trial to Evaluate Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02762812
- Acronym / sponsor ID
- BCD-055-2
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 5 May 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.
BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis.
BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia)
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 |
|---|---|---|
| BCD-055 | Experimental | Biological: BCD-055Patients in this group will receive BCD-055 in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54. |
| Remicade® | Active comparator | Biological: Remicade®Patients in this group will receive Remicade® in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening.
- Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening.
- Mean backache intensity equals 4 points or more.
Key exclusion criteria (9 listed)
- Previous therapy of ankylosing spondylitis with monoclonal antibodies (including tumor necrosis factor)
- Total spinal ankylosis
- History of tuberculosis
- Body mass more than 120 kg
- Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
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 |
|---|---|---|
| BCD-055Also: infliximab | Biological | BCD-055 |
| Remicade®Also: infliximab | Biological | Remicade® |
Primary outcome
Ratio of patients with ASAS20 response after 30 weeks of therapy
Time frame: Week 30
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 30 weeks of therapy with BCD-055.
11 secondary outcomes
Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy
Time frame: Week 14, Week 54
Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Mean change in BASDAI after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Mean change in BASMI after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Mean change in BASFI after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Mean change in MASES after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
Time frame: Week 14, Week 30, Week 54
Frequency of AE/SAE
Time frame: 54 weeks
Frequency of AE 3-4 grade CTCAE
Time frame: 54 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 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Ankylosing Spondylitis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-055 and Remicade® in people with Ankylosing Spondylitis, run by Biocad at 1 site in Russia.
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 4 inclusion and 9 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Ratio of patients with ASAS20 response after 30 weeks of therapy (time frame: Week 30). 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 23 Feb 2018.