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