The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
294
Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
Hospetal for Rheumatic Diseases Hanyang University Medical Center
Seoul, South Korea
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
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
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