NCT02359903

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2015

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 8, 2016

Completed
Last Updated

June 8, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

January 30, 2015

Results QC Date

April 3, 2016

Last Update Submit

May 3, 2016

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (20)

  • Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade

    2 weeks

  • 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

  • +15 more secondary outcomes

Other Outcomes (2)

  • Maximum Concentration at Steady State

    28 weeks

  • Area Under the Plasma Concentration-time Curve at Steady State Phase

    28 weeks

Study Arms (2)

BCD-055 group

EXPERIMENTAL

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

Drug: Infliximab (BCD-055)

Remicade group

ACTIVE COMPARATOR

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

Drug: Infliximab (Remicade)

Interventions

Infliximab (BCD-055)DRUG

infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

Also known as: Remicade, BCD-055
BCD-055 group
Infliximab (Remicade)DRUG
Remicade group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Vitebsk Regional Clinical Hospital

Vitebsk, Belarus

Location

Chelyabinsk Regional Clinical hospital

Chelyabinsk, Russia

Location

Research Institute of Rheumotology

Moscow, Russia

Location

Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko

N.Novgorod, Russia

Location

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, Russia

Location

Local hospital at the station Smolensk OAO RZD

Smolensk, Russia

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

InfliximabBCD-055

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Biryulin Andrey
Organization
BIOCAD
biryulin@biocad.ru
+7812380 49 33

Study Officials

  • Ivanov Roman, PhD

    JCS BIOCAD

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 10, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 8, 2016

Results First Posted

June 8, 2016

Record last verified: 2016-05

Locations

RU(5)BE(1)