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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Vitebsk Regional Clinical Hospital
Vitebsk, Belarus
Chelyabinsk Regional Clinical hospital
Chelyabinsk, Russia
Research Institute of Rheumotology
Moscow, Russia
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
N.Novgorod, Russia
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
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.
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
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North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg, Russia
Local hospital at the station Smolensk OAO RZD
Smolensk, Russia
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