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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: CELBESTA®
* Drug: CELEBREX®
* Drug: CELEBREX® placebo
* Drug: CELBESTA® placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CELBESTA® and CELEBREX® placebo<br>CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks | Drug: CELBESTA®<br>* 1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks<br>* Other names: celecoxib;Drug: CELEBREX® placebo<br>* 1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks<br>* Other names: celecoxib placebo;|
| Active Comparator: CELEBREX®<br>CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks | Drug: CELEBREX®<br>* 1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks<br>* Other names: celecoxib;Drug: CELBESTA® placebo<br>* 1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks<br>* Other names: celecoxib placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of 100mm VAS about pain in study at week 6 |  | week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6 |  | week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celecoxib, CELBESTA