Hospetal for Rheumatic Diseases Hanyang University Medical Center
Seoul, 133-792, South Korea
NCT Number: NCT01270997
The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Phase 3
Seoul, 133-792, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
Other names: HD203
Time frame: 24week
Time frame: 12W, 24W, 48W
Hanwha Chemical
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03649178
Arthritis, Arthritis, Rheumatoid
Nashville, Tennessee, United States
View Trial DetailsNCT03025308
Arthritis, Arthritis, Rheumatoid
Huntsville, Alabama, United States
View Trial DetailsNCT07715045
Arthritis, Arthritis, Rheumatoid
Palembang, South Sumatera, Indonesia
View Trial DetailsNCT00055055
Arthritis, Arthritis, Rheumatoid
Bethesda, Maryland, United States
View Trial Details