Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02359903
• Other study ID #: BCD-055-1/ASART-1
• 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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

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