Rheumatoid Arthritis
Conditions
Keywords
Celecoxib, CELBESTA
Brief summary
This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients
Detailed description
Thisi is 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. The subject will receive two tablets twice daily for 6 weeks.
Interventions
DRUGCELBESTA®
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
DRUGCELEBREX®
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
DRUGCELEBREX® placebo
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
DRUGCELBESTA® placebo
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of 100mm VAS about pain in study at week 6 | week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6 | week 6 |
Countries
South Korea
Outcome results
None listed