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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab (BCD-055) | Drug | infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration at Steady State | 28 weeks | |
| Area Under the Plasma Concentration-time Curve at Steady State Phase | 28 weeks |
Inclusion Criteria:
Exclusion Criteria:
Other exclusion criteria could be found in the Full Study Protocol
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| Name | Affiliation | Role |
|---|---|---|
| Ivanov Roman, PhD | JCS BIOCAD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitebsk Regional Clinical Hospital | Vitebsk | Belarus | ||||
| Chelyabinsk Regional Clinical hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | BCD-055 Group | 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 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha |
| FG001 | Remicade Group | 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 Infliximab (Remicade) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who received at least 1 injection of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | BCD-055 Group | 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 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha |
| BG001 | Remicade Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours 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. | Posted | Median | Inter-Quartile Range | (ng/ml)*hour | 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BCD-055 Group | 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 Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Collapse | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial hypertension | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biryulin Andrey | BIOCAD | +7812380 49 33 | 925 | biryulin@biocad.ru |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| C000706147 | BCD-055 |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Infliximab (Remicade) | Drug |
|
| 2 weeks |
| Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade | 28 weeks |
| Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade | 28 weeks |
| Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade | 28 weeks |
| Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade | 2 weeks / 28 weeks |
| Average Concentration of Infliximab at Steady State Phase | 28 weeks |
| Percentage of Patients in Each Group Achieving ASAS20 | 14 weeks / 30 weeks |
| Percentage of Patients in Each Group Achieving ASAS40 | 14 weeks / 30 weeks |
| Mean Change of BASDAI Score Compared With Baseline | 14 weeks / 30 weeks |
| Mean Change of BASMI Score Compared With Baseline | 14 weeks / 30 weeks |
| Mean Change of BASFI Score Compared With Baseline | 14 weeks / 30 weeks |
| Mean Change of MASES Score Compared With Baseline | 14 weeks / 30 weeks |
| Mean Change of SF36 Score Compared With Baseline | 14 weeks / 30 weeks |
| Mean Change of Chest Expansion Compared With Baseline | 14 weeks / 30 weeks |
| Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade | 2 weeks |
| Total Frequency of AE/SAE Within the Whole Time of the Study | 30 weeks |
| Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study | 30 weeks |
| Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected | screening / 14 weeks / 30 weeks |
| Frequency of Early Withdrawal Due to AE/SAE | 30 weeks |
| Chelyabinsk |
| Russia |
| Research Institute of Rheumotology | Moscow | Russia |
| Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko | N.Novgorod | Russia |
| North-Western State Medical University n.a. I.I.Mechnikov | Saint Petersburg | Russia |
| Local hospital at the station Smolensk OAO RZD | Smolensk | Russia |
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 Infliximab (Remicade) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | ng/ml | 2 weeks |
|
|
|
| Secondary | Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade | Not Posted | 2 weeks |
| Secondary | Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade | Not Posted | 28 weeks |
| Secondary | Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade | Not Posted | 28 weeks |
| Secondary | Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade | Not Posted | 28 weeks |
| Secondary | Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade | Not Posted | 2 weeks / 28 weeks |
| Secondary | Average Concentration of Infliximab at Steady State Phase | Not Posted | 28 weeks |
| Secondary | Percentage of Patients in Each Group Achieving ASAS20 | Not Posted | 14 weeks / 30 weeks |
| Secondary | Percentage of Patients in Each Group Achieving ASAS40 | Not Posted | 14 weeks / 30 weeks |
| Secondary | Mean Change of BASDAI Score Compared With Baseline | Not Posted | 14 weeks / 30 weeks |
| Secondary | Mean Change of BASMI Score Compared With Baseline | Not Posted | 14 weeks / 30 weeks |
| Secondary | Mean Change of BASFI Score Compared With Baseline | Not Posted | 14 weeks / 30 weeks |
| Secondary | Mean Change of MASES Score Compared With Baseline | Not Posted | 14 weeks / 30 weeks |
| Secondary | Mean Change of SF36 Score Compared With Baseline | Not Posted | 14 weeks / 30 weeks |
| Secondary | Mean Change of Chest Expansion Compared With Baseline | Not Posted | 14 weeks / 30 weeks |
| Secondary | Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade | Not Posted | 2 weeks |
| Secondary | Total Frequency of AE/SAE Within the Whole Time of the Study | Not Posted | 30 weeks |
| Secondary | Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study | Not Posted | 30 weeks |
| Secondary | Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected | Not Posted | screening / 14 weeks / 30 weeks |
| Secondary | Frequency of Early Withdrawal Due to AE/SAE | Not Posted | 30 weeks |
| Other Pre-specified | Maximum Concentration at Steady State | Not Posted | Dec 2016 | 28 weeks |
| Other Pre-specified | Area Under the Plasma Concentration-time Curve at Steady State Phase | Not Posted | Dec 2016 | 28 weeks |
| 0 |
| 45 |
| 4 |
| 45 |
| EG001 | Remicade Group | 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 Infliximab (Remicade) | 1 | 45 | 4 | 45 |
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| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |