Overview

This trial is active, not recruiting.

Condition ankylosing spondylitis
Treatments infliximab (bcd-055), infliximab (remicade)
Phase phase 1
Sponsor Biocad
Start date February 2015
End date February 2016
Trial size 90 participants
Trial identifier NCT02359903, BCD-055-1/ASART-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(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
infliximab (bcd-055) Remicade
infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
(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
infliximab (remicade)

Primary Outcomes

Measure
Area under the plasma concentration-time curve at steady state phase
time frame: 28 weeks
Maximum concentration at steady state
time frame: 28 weeks

Secondary Outcomes

Measure
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
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
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - signed informed consent - active ankylosing spondylitis, which exists in patient within last 3 months - BASDAI score > or equal to 4 points, spinal pain (by VAS) > or equal to 4 points - history of NSAID use for the treatment of AS within last 3 months - adequate renal and liver function - absence of severe abnormalities in complete blood count - consent to use adequate contraception - ability to follow Protocol procedures Exclusion Criteria: - previously use of any biologic for AS treatment - total ankylosing of the spine - known allergy to chimeric proteins or any excipients of BCD-055/Remicade - hepatitis B, active hepatitis C, HIV, syphilis - known tuberculosis - latent forms of tuberculosis - any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks) - drug or alcohol abuse - any other disease which can affect assessments or masking some symptoms of AS (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from AS, etc.) - severe uncontrolled hypertension - chronic heart failure - decompensated renal or liver disorders - severe uncontrolled diabetes mellitus - chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis - any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis - unstable angina pectoris - myocardial infarction within last 12 months Other exclusion criteria could be found in the Full Study Protocol

Additional Information

Official title International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Biocad.