At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 90 enrolled
Drug / intervention
Infliximab (BCD-055) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
In Brief
A Phase 1 clinical trial evaluating Infliximab (BCD-055) and Infliximab (Remicade) for Ankylosing Spondylitis. Completed, enrolled 90 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesBelarus, Russia
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedFeb 2015
Primary CompletionNov 2015
TodayJul 2026
First PostedFeb 10, 2015
Enrollment StartFeb 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.4 years ago
Interventions
Infliximab (BCD-055)drug
infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Infliximab (Remicade)drug