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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270997
First Posted: January 6, 2011
Last Update Posted: July 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanwha Chemical
  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: Quadruple (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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
Responsible Party: Hanwha Chemical
ClinicalTrials.gov Identifier: NCT01270997     History of Changes
Other Study ID Numbers: EAGLE-III-10
First Submitted: January 2, 2011
First Posted: January 6, 2011
Last Update Posted: July 15, 2014
Last Verified: July 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