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
Etanercept
Sponsored by

About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
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
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
No
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Learn more about this trial
Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients
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