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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Infliximab (BCD-055)
Infliximab (Remicade)
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vitebsk Regional Clinical Hospital
  • Chelyabinsk Regional Clinical hospital
  • Research Institute of Rheumotology
  • Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
  • Local hospital at the station Smolensk OAO RZD
  • North-Western State Medical University n.a. I.I.Mechnikov

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCD-055 group

Remicade group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade

Secondary Outcome Measures

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 of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade
Average Concentration of Infliximab at Steady State Phase
Percentage of Patients in Each Group Achieving ASAS20
Percentage of Patients in Each Group Achieving ASAS40
Mean Change of BASDAI Score Compared With Baseline
Mean Change of BASMI Score Compared With Baseline
Mean Change of BASFI Score Compared With Baseline
Mean Change of MASES Score Compared With Baseline
Mean Change of SF36 Score Compared With Baseline
Mean Change of Chest Expansion Compared With Baseline
Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade
Total Frequency of AE/SAE Within the Whole Time of the Study
Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study
Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected
Frequency of Early Withdrawal Due to AE/SAE

Full Information

First Posted
January 30, 2015
Last Updated
May 3, 2016
Sponsor
Biocad
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1. Study Identification

Unique Protocol Identification Number
NCT02359903
Brief Title
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Official Title
International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCD-055 group
Arm Type
Experimental
Arm Description
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
Arm Title
Remicade group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Infliximab (BCD-055)
Other Intervention Name(s)
Remicade, BCD-055
Intervention Description
infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Intervention Type
Drug
Intervention Name(s)
Infliximab (Remicade)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Description
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
Title
Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
Time Frame
2 weeks
Title
Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Time Frame
28 weeks
Title
Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Time Frame
28 weeks
Title
Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
Time Frame
28 weeks
Title
Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade
Time Frame
2 weeks / 28 weeks
Title
Average Concentration of Infliximab at Steady State Phase
Time Frame
28 weeks
Title
Percentage of Patients in Each Group Achieving ASAS20
Time Frame
14 weeks / 30 weeks
Title
Percentage of Patients in Each Group Achieving ASAS40
Time Frame
14 weeks / 30 weeks
Title
Mean Change of BASDAI Score Compared With Baseline
Time Frame
14 weeks / 30 weeks
Title
Mean Change of BASMI Score Compared With Baseline
Time Frame
14 weeks / 30 weeks
Title
Mean Change of BASFI Score Compared With Baseline
Time Frame
14 weeks / 30 weeks
Title
Mean Change of MASES Score Compared With Baseline
Time Frame
14 weeks / 30 weeks
Title
Mean Change of SF36 Score Compared With Baseline
Time Frame
14 weeks / 30 weeks
Title
Mean Change of Chest Expansion Compared With Baseline
Time Frame
14 weeks / 30 weeks
Title
Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade
Time Frame
2 weeks
Title
Total Frequency of AE/SAE Within the Whole Time of the Study
Time Frame
30 weeks
Title
Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study
Time Frame
30 weeks
Title
Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected
Time Frame
screening / 14 weeks / 30 weeks
Title
Frequency of Early Withdrawal Due to AE/SAE
Time Frame
30 weeks
Other Pre-specified Outcome Measures:
Title
Maximum Concentration at Steady State
Time Frame
28 weeks
Title
Area Under the Plasma Concentration-time Curve at Steady State Phase
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivanov Roman, PhD
Organizational Affiliation
JCS BIOCAD
Official's Role
Study Chair
Facility Information:
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
Country
Belarus
Facility Name
Chelyabinsk Regional Clinical hospital
City
Chelyabinsk
Country
Russian Federation
Facility Name
Research Institute of Rheumotology
City
Moscow
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
City
N.Novgorod
Country
Russian Federation
Facility Name
Local hospital at the station Smolensk OAO RZD
City
Smolensk
Country
Russian Federation
Facility Name
North-Western State Medical University n.a. I.I.Mechnikov
City
St.Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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