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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hanwha Chemical
ClinicalTrials.gov Identifier:
NCT01270997
First received: January 2, 2011
Last updated: September 6, 2011
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 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
Genders Eligible for Study:   Both
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
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

No publications provided

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: September 6, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013