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

NCT02359903 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-06-08

Study results available
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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.

Conditions

Interventions

DRUG

Infliximab (BCD-055)

infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha

DRUG

Infliximab (Remicade)

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Ivanov Roman, PhD · JCS BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Belarus
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02359903 on ClinicalTrials.gov