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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02359903
Other study ID # BCD-055-1/ASART-1
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received January 30, 2015
Last updated January 12, 2016
Start date February 2015
Est. completion date December 2016

Study information

Verified date January 2016
Source Biocad
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date December 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Infliximab (BCD-055)
infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Infliximab (Remicade)


Locations

Country Name City State
Belarus Vitebsk Regional Clinical Hospital Vitebsk
Russian Federation Chelyabinsk Regional Clinical hospital Chelyabinsk
Russian Federation Research Institute of Rheumotology Moscow
Russian Federation Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko N.Novgorod
Russian Federation Local hospital at the station Smolensk OAO RZD Smolensk
Russian Federation North-Western State Medical University n.a. I.I.Mechnikov St.Petersburg

Sponsors (1)

Lead Sponsor Collaborator
Biocad

Countries where clinical trial is conducted

Belarus,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration-time curve at steady state phase 28 weeks No
Primary Maximum concentration at steady state 28 weeks No
Secondary Area under the plasma concentration-time curve from zero (0) hours to 336 hours after the single infusion of BCD-055/Remicade 2 weeks No
Secondary Maximum concentration of infliximab after the single infusion of BCD-055/Remicade 2 weeks No
Secondary Time of maximum concentration of infliximab after the single infusion of BCD-055/Remicade 2 weeks No
Secondary Maximum concentration of infliximab after the 1st, 2nd, 3rd, 4th and 5th infusion of BCD-055/Remicade 28 weeks No
Secondary Minimum concentration of infliximab after the 1st, 2nd, 3rd, 4th and 5th infusion of BCD-055/Remicade 28 weeks No
Secondary Time of maximum concentration of infliximab after the1st, 2nd, 3rd, 4th and 5th infusion of BCD-055/Remicade 28 weeks No
Secondary Half life of infliximab after the 1st and 5th infusion of BCD-055/Remicade 2 weeks / 28 weeks No
Secondary Average concentration of infliximab at steady state phase 28 weeks No
Secondary Percentage of patients in each group achieving ASAS20 14 weeks / 30 weeks No
Secondary Percentage of patients in each group achieving ASAS40 14 weeks / 30 weeks No
Secondary Mean change of BASDAI score compared with baseline 14 weeks / 30 weeks No
Secondary Mean change of BASMI score compared with baseline 14 weeks / 30 weeks No
Secondary Mean change of BASFI score compared with baseline 14 weeks / 30 weeks No
Secondary Mean change of MASES score compared with baseline 14 weeks / 30 weeks No
Secondary Mean change of SF36 score compared with baseline 14 weeks / 30 weeks No
Secondary Mean change of chest expansion compared with baseline 14 weeks / 30 weeks No
Secondary Frequency of AE/SAE after the single infusion of BCD-055/Remicade 2 weeks Yes
Secondary Total frequency of AE/SAE within the whole time of the study 30 weeks Yes
Secondary Total frequency of grade 3-4 laboratory abnormalities within the whole time of the study 30 weeks Yes
Secondary Percentage of patients in whom bind or neutralizing antibodies to infliximab were detected screening / 14 weeks / 30 weeks No
Secondary Frequency of early withdrawal due to AE/SAE 30 weeks Yes
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