Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

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.

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