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

July 13, 2014 updated by: Hanwha Chemical

A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase Ⅲ Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

To prove the equivalence between two groups by comparing the ACR20 of W24 with the baseline after injecting HD203 25mg and (Enbrel®) 25mg into the patients with rheumatoid arthritis for 24 weeks.

Secondary Objective:

To compare the efficacy of ACR20, ACR50 and ACR70, etc along with safety in adverse event, vital signs, Laboratory test, physical examination and immunogenicity, etc between two groups with baseline after injecting HD203 25mg and (Enbrel®) 25mg into patients with rheumatoid arthritis for 48 weeks.

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 133-792
        • Hospetal for Rheumatic Diseases Hanyang University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females who are 20 or over
  • Patients who satisfy the classification criteria of Rheumatoid Arthritis according to American Colleague of Rheumatology (ACR 1987)
  • Patients who are applicable to functional status I - III of American Colleague of Rheumatology

Exclusion Criteria:

  • Patients who have autoimmune diseases other than rheumatoid arthritis or have significant secondary systematic disease caused by rheumatoid arthritis
  • Patients who are currently participating in other clinical studies or receiving treatment for drugs not sold in the market or for experiment
  • Patients who have significant other diseases that may affect the clinical trial when judged by the clinical trial Investigator
  • In the opinion of the investigator, may put the patient at risk because of participation on the study or may influence the patients' ability to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HD203
Subcutaneous injection (SC) HD203 25mg twice a week for 48 weeks
Biological: Etanercept
Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
Other Names:
  • Enbrel
Active Comparator: Enbrel
Subcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks.
Biological: Etanercept
Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
Other Names:
  • Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To prove the equivalence between two groups by comparing the ACR20 of W24 with the baseline after injecting HD203 and Enbrel® into rheumatoid arthritis patients for 24 weeks.
Time Frame: 24week
24week

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the efficacy of ACR20, ACR50 and ACR70 along with safety and immunogenicity between two groups with baseline after injecting HD203 and Enbrel® into rheumatoid arthritis patients for 48 weeks
Time Frame: 12W, 24W, 48W
12W, 24W, 48W

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanwha Chemical

Investigators

  • Principal Investigator: Sang Chul Bae, MD, PhD, MPH, Hanyang University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 2, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 13, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAGLE-III-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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