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The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis

NCT03455842 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-11-18

No results posted yet for this study

Summary

The study is Phase II randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety, pharmacokinetics and pharmacodynamics of 2 dosing regimens (qw and q2w, s/c) of monoclonal antibody to IL6R (BCD-089) in patients with active rheumatoid arthritis and inadequate response to methotrexate.

Conditions

  • Seropositive RA

Interventions

BIOLOGICAL

BCD-089, 162 mg, s/c, qw

Subcutaneous injections of anti-IL6R every week

BIOLOGICAL

BCD-089, 162 mg, s/c, q2w

Subcutaneous injections of anti-IL6R every other week

DRUG

placebo

Subcutaneous injections of placebo every week, until week 12. Thereafter subcutaneous injections of anti-IL6R every other week

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman Ivanov, PhD · Biocad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-12-31
Completion
2019-10-22

Countries

  • Belarus
  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT03455842 on ClinicalTrials.gov