Ankylosing SpondylitisPhase 1NCT02359903
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
A Phase 1 study testing Infliximab (BCD-055) and Infliximab (Remicade) in people with Ankylosing Spondylitis, run by Biocad at 6 sites in 2 countries.
Trial summary
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis. 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?
- Infliximab (BCD-055) and Infliximab (Remicade)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2015to Nov 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, which exists in patient within last 3 months
- BASDAI score > or equal to 4 points, spinal pain (by VAS) > or equal to 4 points
- history of NSAID use for the treatment of AS within last 3 months
- adequate renal and liver function
- absence of severe abnormalities in complete blood count
- consent to use adequate contraception
- ability to follow Protocol procedures
Who cannot join
- previously use of any biologic for AS treatment
- total ankylosing of the spine
- known allergy to chimeric proteins or any excipients of BCD-055/Remicade
- hepatitis B, active hepatitis C, HIV, syphilis
- known tuberculosis
- latent forms of tuberculosis
Show all 18Show fewer
- any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks)
- drug or alcohol abuse
- any other disease which can affect assessments or masking some symptoms of AS (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from AS, etc.)
- severe uncontrolled hypertension
- chronic heart failure
- decompensated renal or liver disorders
- severe uncontrolled diabetes mellitus
- chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis
- any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis
- unstable angina pectoris
- myocardial infarction within last 12 months
- Other exclusion criteria could be found in the Full Study Protocol
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Russia5 sites
Chelyabinsk Regional Clinical hospital
Chelyabinsk
Research Institute of Rheumotology
Moscow
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
N.Novgorod
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg
Local hospital at the station Smolensk OAO RZD
Smolensk
About this study
Official title: International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.
Read the detailed description
ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to Remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (AS).
The study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive Remicade at the same regimen.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Infliximab (BCD-055), Infliximab (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.
Infliximab (BCD-055)Drug
Also called Remicade, BCD-055
infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Infliximab (Remicade)Drug
| Study group | Role | What they receive |
|---|---|---|
| BCD-055 group | Experimental | BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Receives: Drug: Infliximab (BCD-055) |
| Remicade group | Active comparator | Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 Receives: Drug: Infliximab (Remicade) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade
Measured: 2 weeks
Secondary outcomes (20)
Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.
Measured: 2 weeks
Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Measured: 2 weeks
Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Measured: 28 weeks
Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Measured: 28 weeks
Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Measured: 28 weeks
Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade
Measured: 2 weeks / 28 weeks
Average Concentration of Infliximab at Steady State Phase
Measured: 28 weeks
Percentage of Patients in Each Group Achieving ASAS20
Measured: 14 weeks / 30 weeks
Percentage of Patients in Each Group Achieving ASAS40
Measured: 14 weeks / 30 weeks
Mean Change of BASDAI Score Compared With Baseline
Measured: 14 weeks / 30 weeks
Mean Change of BASMI Score Compared With Baseline
Measured: 14 weeks / 30 weeks
Mean Change of BASFI Score Compared With Baseline
Measured: 14 weeks / 30 weeks
Mean Change of MASES Score Compared With Baseline
Measured: 14 weeks / 30 weeks
Mean Change of SF36 Score Compared With Baseline
Measured: 14 weeks / 30 weeks
Mean Change of Chest Expansion Compared With Baseline
Measured: 14 weeks / 30 weeks
Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade
Measured: 2 weeks
Total Frequency of AE/SAE Within the Whole Time of the Study
Measured: 30 weeks
Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study
Measured: 30 weeks
Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected
Measured: screening / 14 weeks / 30 weeks
Frequency of Early Withdrawal Due to AE/SAE
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivanov Roman, PhD, Study chair, JCS BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359903
- Sponsor's protocol ID
- BCD-055-1/ASART-1
- Status last verified
- May 2016
- First submitted
- 30 Jan 2015
- Last updated
- 8 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02359903
- Acronym / sponsor ID
- BCD-055-1/ASART-1
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 8 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.
Detailed description
ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to Remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (AS).
The study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive Remicade at the same regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-055 group | Experimental | Drug: Infliximab (BCD-055)BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 |
| Remicade group | Active comparator | Drug: Infliximab (Remicade)Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- signed informed consent
- active ankylosing spondylitis, which exists in patient within last 3 months
- BASDAI score > or equal to 4 points, spinal pain (by VAS) > or equal to 4 points
- history of NSAID use for the treatment of AS within last 3 months
- adequate renal and liver function
Key exclusion criteria (18 listed)
- previously use of any biologic for AS treatment
- total ankylosing of the spine
- known allergy to chimeric proteins or any excipients of BCD-055/Remicade
- hepatitis B, active hepatitis C, HIV, syphilis
- known tuberculosis
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 |
|---|---|---|
| Infliximab (BCD-055)Also: Remicade, BCD-055infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha | Drug | BCD-055 group |
| Infliximab (Remicade) | Drug | Remicade group |
Primary outcome
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade
Time frame: 2 weeks
20 secondary outcomes
Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Time frame: 2 weeks
Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Time frame: 2 weeks
Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Time frame: 28 weeks
Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Time frame: 28 weeks
Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Time frame: 28 weeks
Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade
Time frame: 2 weeks / 28 weeks
Average Concentration of Infliximab at Steady State Phase
Time frame: 28 weeks
Percentage of Patients in Each Group Achieving ASAS20
Time frame: 14 weeks / 30 weeks
Percentage of Patients in Each Group Achieving ASAS40
Time frame: 14 weeks / 30 weeks
Mean Change of BASDAI Score Compared With Baseline
Time frame: 14 weeks / 30 weeks
Mean Change of BASMI Score Compared With Baseline
Time frame: 14 weeks / 30 weeks
Mean Change of BASFI Score Compared With Baseline
Time frame: 14 weeks / 30 weeks
Mean Change of MASES Score Compared With Baseline
Time frame: 14 weeks / 30 weeks
Mean Change of SF36 Score Compared With Baseline
Time frame: 14 weeks / 30 weeks
Mean Change of Chest Expansion Compared With Baseline
Time frame: 14 weeks / 30 weeks
Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade
Time frame: 2 weeks
Total Frequency of AE/SAE Within the Whole Time of the Study
Time frame: 30 weeks
Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study
Time frame: 30 weeks
Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected
Time frame: screening / 14 weeks / 30 weeks
Frequency of Early Withdrawal Due to AE/SAE
Time frame: 30 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ivanov Roman, PhD study chair
JCS BIOCAD
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infliximab (BCD-055) and Infliximab (Remicade) in people with Ankylosing Spondylitis, run by Biocad at 6 sites in 2 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 8 inclusion and 18 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 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia, Belarus. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade (time frame: 2 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 8 Jun 2016.