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This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CELBESTA® and CELEBREX® placebo | Experimental | CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks |
|
| CELEBREX® | Active Comparator | CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELBESTA® | Drug | 1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of 100mm VAS about pain in study at week 6 | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6 | week 6 |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Seung-jae Hong, MD,PhD | Kyung Hee University Hospital | Principal Investigator |
| Sungsoo Kim, MD,PhD | Gangneung Asan Hospital | Principal Investigator |
| Sangil Lee, MD,PhD | Gyeongsang National Hospital | Principal Investigator |
| Changnam Son, MD,PhD | Keimyung University Dongsan Medical Center | Principal Investigator |
| Yeong Ho Seo, MD,PhD | Korea University | Principal Investigator |
| Geun-Tae Kim, MD,PhD | Kosin University Gospel Hospital | Principal Investigator |
| Jin-Wuk Hur, MD,PhD | Seoul Eulji Hospital | Principal Investigator |
| Hyun-Sook Kim, MD,PhD | Soonchunhyang University Hospital | Principal Investigator |
| Myeong Soo Lee, MD,PhD | Wonkwang University Hospital | Principal Investigator |
| Yun Sung Kim, MD,PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Seoul | 130-702 | South Korea |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| CELEBREX® | Drug | 1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks |
|
|
| CELEBREX® placebo | Drug | 1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks |
|
|
| CELBESTA® placebo | Drug | 1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks |
|
|
| Chosun University Hospital |
| Principal Investigator |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |