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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Etanercept
* Biological: Etanercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD203<br>Subcutaneous injection (SC) HD203 25mg twice a week for 48 weeks | Biological: Etanercept<br>* Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks<br>* Other names: HD203;|
| Active Comparator: Enbrel<br>Subcutaneous injection (SC) Enbrel® 25mg twice a week for 48 weeks. | Biological: Etanercept<br>* Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |