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Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

NCT02762838 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2019-06-14

No results posted yet for this study

Summary

BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

BCD-055

BCD-055 is infliximab biosimilar

BIOLOGICAL

Remicade®

DRUG

Methotrexate

All patients will receive methotrexate in a dose from 10 to 25 mg per week.

DRUG

Folic acid

All patients will receive folic acid in a dose of 5 mg per week.

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman Ivanov, PhD · JSC BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Belarus
  • India
  • 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 NCT02762838 on ClinicalTrials.gov