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

Hanwha Chemical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270997

EAGLE-III-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 294 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 2 patient groups

HD203

Experimental group

Description:

Subcutaneous injection (SC) HD203 25mg twice a week for 48 weeks

Treatment:

Biological: Etanercept

Biological: Etanercept

Enbrel

Active Comparator group

Description:

Subcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks.

Treatment:

Biological: Etanercept

Biological: Etanercept