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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 phase

Maximum 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/Remicade

Maximum 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

Page last updated: August 23, 2015

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