Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
1050
Trial Sponsor
Clinical Trial Start Date
February 1, 2018
0Primary Completion Date
December 31, 2018
0Study Completion Date
October 22, 2019
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Drug0
Intervention Name
BCD-089, 162 mg, s/c, qw0
placebo0
BCD-089, 162 mg, s/c, q2w0
Interventional Trial Phase
Phase 20
Participating Facility
Official Name
International Multicenter Comparative Randomized Double-blind Placebo-controlled Clinical Study of Efficacy and Safety of BCD-089 in Different Dosing Regimens in Patients With Active Rheumatoid Arthritis0
Last Updated
November 18, 2021
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Investigator0
Outcomes Assessor0
Care Provider0
Participant0
Study summary
The study is Phase II randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety, pharmacokinetics and pharmacodynamics of 2 dosing regimens (qw and q2w, s/c) of monoclonal antibody to IL6R (BCD-089) in patients with active rheumatoid arthritis and inadequate response to methotrexate.
Timeline
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Further Resources
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