Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2017-12-26
• Target enrollment: 0
• Participant gender: All

Summary

This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Celecoxib

Criteria

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