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
Verified date | July 2014 |
Source | Hanwha Chemical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
The objective is to prove the equivalence in efficacy and safety of HD203 and Enbrel® in combination with Methotrexate in patients with rheumatoid arthritis.
Status | Completed |
Enrollment | 294 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hospetal for Rheumatic Diseases Hanyang University Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanwha Chemical |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | 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 | Yes |
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