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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270997
• Other study ID #: EAGLE-III-10
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2011
• Last updated: July 13, 2014
• Start date: December 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2014
• Source: Hanwha Chemical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hospetal for Rheumatic Diseases Hanyang University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanwha Chemical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24week	Yes
Secondary	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		12W, 24W, 48W	Yes