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Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

NCT04227366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2022-05-12

No results posted yet for this study

Summary

BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor.

The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate.

Conditions

Interventions

BIOLOGICAL

BCD-089

BCD-089 162 mg SC

BIOLOGICAL

Placebo

Placebo

DRUG

Methotrexat

15 to 25 mg/week

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Yulia Linkova, MD, PhD · JSC BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2021-03-15
Completion
2022-03-01

Countries

  • Russia

Study Locations

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Entities

Drugs
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 NCT04227366 on ClinicalTrials.gov