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A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

NCT02167139 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2017-08-17

Study results available
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Summary

This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.

Conditions

Interventions

DRUG

Humira (adalimumab)

DRUG

SB5 (proposed biosimilar to adalimumab)

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Asta Baranauskaite, M.D., Ph.D. · Hospital of Lithuanian University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-04-30
Completion
2015-10-31

Countries

  • Lithuania
  • Poland

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 NCT02167139 on ClinicalTrials.gov