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Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients

NCT01270997 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2014-07-15

No results posted yet for this study

Summary

The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

Etanercept

Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks

BIOLOGICAL

Etanercept

Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks

Sponsors & Collaborators

  • Hanwha Chemical

    lead INDUSTRY

Principal Investigators

  • Sang Chul Bae, MD, PhD, MPH · Hanyang University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Korea

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 NCT01270997 on ClinicalTrials.gov