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

NCT ID: NCT02359903

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-11-30

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Infliximab (BCD-055)

Intervention Type: DRUG

infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

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

Group Type: ACTIVE_COMPARATOR

Infliximab (Remicade)

Intervention Type: DRUG

Interventions

Infliximab (BCD-055)

infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

Intervention Type: DRUG

Infliximab (Remicade)

Intervention Type: DRUG

Other Intervention Names

Remicade; BCD-055

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivanov Roman, PhD

Role: STUDY_CHAIR

JCS BIOCAD

Locations

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

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, , Russia

Local hospital at the station Smolensk OAO RZD

Smolensk, , Russia

Countries

Belarus; Russia

Other Identifiers

BCD-055-1/ASART-1

Identifier Type: -

Identifier Source: org_study_id