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Completed

NCT Number: NCT01270997

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospetal for Rheumatic Diseases Hanyang University Medical Center

Seoul, 133-792, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Biological

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

Other names: HD203

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hanwha Chemical

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2011
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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