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

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: Etanercept	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Hanwha Chemical:

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. [ Time Frame: 24week ]

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 [ Time Frame: 12W, 24W, 48W ]


Enrollment:	294
Study Start Date:	December 2010
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: HD203
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 Name: Enbrel

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.

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270997

Locations


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

Sponsors and Collaborators

Hanwha Chemical

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Hanwha Chemical
ClinicalTrials.gov Identifier:	NCT01270997 History of Changes
Other Study ID Numbers:	EAGLE-III-10
Study First Received:	January 2, 2011
Last Updated:	July 13, 2014

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Etanercept Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors

ClinicalTrials.gov processed this record on July 17, 2017