Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Registration Number
- NCT02359903
- Lead Sponsor
- Biocad
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remicade group Infliximab (Remicade) 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 BCD-055 group Infliximab (BCD-055) 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
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade 2 weeks
- Secondary Outcome Measures
Name Time Method Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade 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 2 weeks Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade 28 weeks Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade 28 weeks Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade 28 weeks Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade 2 weeks / 28 weeks Average Concentration of Infliximab at Steady State Phase 28 weeks Percentage of Patients in Each Group Achieving ASAS20 14 weeks / 30 weeks Percentage of Patients in Each Group Achieving ASAS40 14 weeks / 30 weeks Mean Change of BASDAI Score Compared With Baseline 14 weeks / 30 weeks Mean Change of BASMI Score Compared With Baseline 14 weeks / 30 weeks Mean Change of BASFI Score Compared With Baseline 14 weeks / 30 weeks Mean Change of MASES Score Compared With Baseline 14 weeks / 30 weeks Mean Change of SF36 Score Compared With Baseline 14 weeks / 30 weeks Mean Change of Chest Expansion Compared With Baseline 14 weeks / 30 weeks Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade 2 weeks Total Frequency of AE/SAE Within the Whole Time of the Study 30 weeks Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study 30 weeks Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected screening / 14 weeks / 30 weeks Frequency of Early Withdrawal Due to AE/SAE 30 weeks
Trial Locations
- Locations (6)
Vitebsk Regional Clinical Hospital
🇧🇾Vitebsk, Belarus
Chelyabinsk Regional Clinical hospital
🇷🇺Chelyabinsk, Russian Federation
Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
🇷🇺N.Novgorod, Russian Federation
North-Western State Medical University n.a. I.I.Mechnikov
🇷🇺St.Petersburg, Russian Federation
Research Institute of Rheumotology
🇷🇺Moscow, Russian Federation
Local hospital at the station Smolensk OAO RZD
🇷🇺Smolensk, Russian Federation