Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Information source: Biocad
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Infliximab (BCD-055) (Drug); Infliximab (Remicade) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Biocad Official(s) and/or principal investigator(s): Ivanov Roman, PhD, Study Chair, Affiliation: JCS BIOCAD
Overall contact: Andrey Biryulin, MD, Phone: +78123804934, Ext: 925, Email: biryulin@biocad.ru
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.
Clinical Details
Official title: International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Area under the plasma concentration-time curve at steady state phaseMaximum concentration at steady state
Secondary outcome: Area under the plasma concentration-time curve from zero (0) hours to 336 hours after the single infusion of BCD-055/RemicadeMaximum concentration of infliximab after the single infusion of BCD-055/Remicade 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
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Andrey Biryulin, MD, Phone: +78123804934, Ext: 925, Email: biryulin@biocad.ru
Vitebsk Regional Clinical Hospital, Vitebsk, Belarus; Not yet recruiting
Chelyabinsk Regional Clinical hospital, Chelyabinsk, Russian Federation; Recruiting
Research Institute of Rheumotology, Moscow, Russian Federation; Not yet recruiting Marina L. Stanislav, Principal Investigator
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko, N.Novgorod, Russian Federation; Recruiting
Local hospital at the station Smolensk OAO RZD, Smolensk, Russian Federation; Recruiting
North-Western State Medical University n.a. I.I.Mechnikov, St.Petersburg, Russian Federation; Recruiting
Additional Information
Starting date: February 2015
Last updated: July 27, 2015
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