Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475508
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
Comparison of Complarate Tocilizumab Biosimilar and Actemra in Patients With Rheumatoid Arthritis
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
Double-blind Multicenter Randomized Study of the Effectiveness and Safety of Tocilizumab Biosimilar Complarate and Actemra in Parallel Groups in Patients With Rheumatoid Arthritis With Repeated Intravenous Administration
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind comparative parallel group study of the efficacy and safety of tocilizumab biosimilar Complarate and Actemra in the treatment of patients with rheumatoid arthritis with moderate to high disease activity Participants received an intravenous dose of tocilizumab 8 mgkg once 4 weeks The time on study treatment was 24 weeks
Detailed Description:
Complarate INN tocilizumab is being developed as a biosimilar to the drug Actemra a concentrate for the preparation of a solution for infusion
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 IL-6 receptor from the immunoglobulin G1 IgG1 subclass of immunoglobulins Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors
This III phase study is aimed to compare the effectiveness safety and immunogenicity of Complarate and Actemra The study included patients aged 18-75 years at the time of signing the informed consent form with a documented diagnosis of rheumatoid artritis established according to the 2010 ACREULAR classification criteria at least 6 months before screening with moderate or high degree of disease activity and insufficient response to methotrexate monotherapy preservation of moderatehigh disease activity for at least 3 months andor poor tolerability of methotrexate including the subcutaneous form of the drug andor insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs sDMARDs with or without methotrexate inclusive who meet all criteria for participation in the study The study included a screening period and a treatment period Allocation of patients to treatment groups was carried out by randomization in a ratio of 21 to the study drug Complarate and comparator drug Actemra 465 patients 310 to the study drug group and 155 to the comparator drug group were randomized
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 IL-6 receptor from the immunoglobulin G1 IgG1 subclass of immunoglobulins Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors
This III phase study is aimed to compare the effectiveness safety and immunogenicity of Complarate and Actemra The study included patients aged 18-75 years at the time of signing the informed consent form with a documented diagnosis of rheumatoid artritis established according to the 2010 ACREULAR classification criteria at least 6 months before screening with moderate or high degree of disease activity and insufficient response to methotrexate monotherapy preservation of moderatehigh disease activity for at least 3 months andor poor tolerability of methotrexate including the subcutaneous form of the drug andor insufficient response to or intolerance to other synthetic disease-modifying anti-inflammatory drugs sDMARDs with or without methotrexate inclusive who meet all criteria for participation in the study The study included a screening period and a treatment period Allocation of patients to treatment groups was carried out by randomization in a ratio of 21 to the study drug Complarate and comparator drug Actemra 465 patients 310 to the study drug group and 155 to the comparator drug group were randomized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None