Clinical trial NCT02780323: Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Celecoxib
CELBESTA
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-23
Enrollment: 119
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline of 100mm VAS about pain in study at week 6
timeFrame: week 6
Secondary outcomes:
measure: Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6
timeFrame: week 6
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Seung-jae Hong, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangneung Asan Hospital
name: Sungsoo Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gyeongsang National Hospital
name: Sangil Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Changnam Son, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: Yeong Ho Seo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kosin University Gospel Hospital
name: Geun-Tae Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Eulji Hospital
name: Jin-Wuk Hur, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Hyun-Sook Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Myeong Soo Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chosun University Hospital
name: Yun Sung Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: