Rheumatoid Arthritis Clinical Trial
Official title:
A Multi-center, Double-blind, Active-controlled, Randomized, Parallel-group Clinical Trial to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis
Verified date | February 2020 |
Source | Dong-A ST Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients
Status | Completed |
Enrollment | 119 |
Est. completion date | December 26, 2017 |
Est. primary completion date | December 26, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Anyone over the age of 19 - Subjects who are diagnosed as established rheumatoid arthritis at screening visit and before - Pain greater than 40/100mm-VAS(Visual Analgue Scale) after wash-out period - Patients who are taking oral corticosteroids without dosage change (within a range of prednisolone 10mg a day) at least 4weeks and more than 1 DMARDs at least 3 months from screening test - Patients willing and able to provide signed informed consent after the nature of the study has been explained Exclusion Criteria: - History of angina pectoris or congestive heart failure at rest or minimum activity - History of myocardial infarction or artherosclerosis - Patients who had a coronary angioplaty or coronary artery bypass graft within 1 year - History of stroke, transient ischemic attack or hepatitis within 2 years - Patients who have uncontrolled hypertension at screening - Patients who take the medicines that might effect the test results by study investigators or might cause a excessive risk to the patients - Intra-articular corticosteroid injection within 4 weeks from screening - biological DMARDs such as infliximab, adlimumab, entanercept, anakinara or abatacept wihin 6 months from randomization - biological DMARDs such as rituximab within 1 year from randomization - History of a malignant tumor (except for the patients whose tumor was removed and there's no recurrence within 5 years) - Patients who have gastrointestinal bleeding or peptic ulcer (except scar) within 30 days - History of a gastroesophageal surgery such as antigastric-secretion surgery or esophagogastrectomy (except a simple perforator surgery) - Patients who have severe disability in GI, Kidney, Liver and Blood - Pregnant women, Lactating women and Women of child-bering potential who are not using adequate means of contraception - History of allergy to COX-2 inhibitors or sulphonamides or other NSAIDs - Any condition that, in the view of the investigator, would interfere with study participation |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Dong-A ST Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline of 100mm VAS about pain in study at week 6 | week 6 | ||
Secondary | Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6 | week 6 |
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