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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Etanercept

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospetal for Rheumatic Diseases Hanyang University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HD203

Enbrel

Arm Description

Subcutaneous injection (SC) HD203 25mg twice a week for 48 weeks

Subcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01270997

First Posted

January 2, 2011

Last Updated

July 13, 2014

Sponsor

Hanwha Chemical

1. Study Identification

Unique Protocol Identification Number

NCT01270997

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanwha Chemical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

294 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HD203

Arm Type

Experimental

Arm Description

Subcutaneous injection (SC) HD203 25mg twice a week for 48 weeks

Arm Title

Enbrel

Arm Type

Active Comparator

Arm Description

Subcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks.

Intervention Type

Biological

Intervention Name(s)

Etanercept

Other Intervention Name(s)

HD203

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Etanercept

Other Intervention Name(s)

Enbrel

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

12W, 24W, 48W

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang Chul Bae, MD, PhD, MPH

Organizational Affiliation

Hanyang University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospetal for Rheumatic Diseases Hanyang University Medical Center

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26905864

Citation

Bae SC, Kim J, Choe JY, Park W, Lee SH, Park YB, Shim SC, Lee SS, Sung YK, Choi CB, Lee SR, Park H, Ahn Y; HERA Study Investigators. A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study. Ann Rheum Dis. 2017 Jan;76(1):65-71. doi: 10.1136/annrheumdis-2015-207613. Epub 2016 Feb 23.

Results Reference

derived

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

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