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

Overview

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.

Full Title of Study: “International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2015

Detailed 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.

Interventions

  • Drug: Infliximab (BCD-055)
    • infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
  • Drug: Infliximab (Remicade)

Arms, Groups and Cohorts

  • Experimental: BCD-055 group
    • 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
  • Active Comparator: Remicade group
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
    • Time Frame: 2 weeks
    • 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biocad
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ivanov Roman, PhD, Study Chair, JCS BIOCAD

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