Clinical trial NCT02359903: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ankylosing Spondylitis
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2015-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade
timeFrame: 2 weeks
Secondary outcomes:
measure: Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
timeFrame: 2 weeks
measure: Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
timeFrame: 2 weeks
measure: Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
timeFrame: 28 weeks
measure: Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
timeFrame: 28 weeks
measure: Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade
timeFrame: 28 weeks
measure: Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade
timeFrame: 2 weeks / 28 weeks
measure: Average Concentration of Infliximab at Steady State Phase
timeFrame: 28 weeks
measure: Percentage of Patients in Each Group Achieving ASAS20
timeFrame: 14 weeks / 30 weeks
measure: Percentage of Patients in Each Group Achieving ASAS40
timeFrame: 14 weeks / 30 weeks
measure: Mean Change of BASDAI Score Compared With Baseline
timeFrame: 14 weeks / 30 weeks
measure: Mean Change of BASMI Score Compared With Baseline
timeFrame: 14 weeks / 30 weeks
measure: Mean Change of BASFI Score Compared With Baseline
timeFrame: 14 weeks / 30 weeks
measure: Mean Change of MASES Score Compared With Baseline
timeFrame: 14 weeks / 30 weeks
measure: Mean Change of SF36 Score Compared With Baseline
timeFrame: 14 weeks / 30 weeks
measure: Mean Change of Chest Expansion Compared With Baseline
timeFrame: 14 weeks / 30 weeks
measure: Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade
timeFrame: 2 weeks
measure: Total Frequency of AE/SAE Within the Whole Time of the Study
timeFrame: 30 weeks
measure: Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study
timeFrame: 30 weeks
measure: Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected
timeFrame: screening / 14 weeks / 30 weeks
measure: Frequency of Early Withdrawal Due to AE/SAE
timeFrame: 30 weeks
Other outcomes:
measure: Maximum Concentration at Steady State
timeFrame: 28 weeks
measure: Area Under the Plasma Concentration-time Curve at Steady State Phase
timeFrame: 28 weeks
Locations:
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical hospital
city: Moscow
country: Russian Federation
facility: Research Institute of Rheumotology
city: N.Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
city: Smolensk
country: Russian Federation
facility: Local hospital at the station Smolensk OAO RZD
city: St.Petersburg
country: Russian Federation
facility: North-Western State Medical University n.a. I.I.Mechnikov
Study officials:
affiliation: JCS BIOCAD
name: Ivanov Roman, PhD
role: STUDY_CHAIR
References: