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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02780323 |
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Date of registration:
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19/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis
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Scientific 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 |
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Date of first enrolment:
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November 2, 2015 |
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Target sample size:
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119 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02780323 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jin-Wuk Hur, MD,PhD |
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Address:
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Email:
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Affiliation:
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Seoul Eulji Hospital |
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Name:
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Hyun-Sook Kim, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Soonchunhyang University Hospital |
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Name:
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Sungsoo Kim, MD,PhD |
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Address:
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Email:
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Affiliation:
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Gangneung Asan Hospital |
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Name:
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Yeong Ho Seo, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korea University |
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Name:
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Myeong Soo Lee, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wonkwang University Hospital |
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Name:
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Yun Sung Kim, MD,PhD |
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Address:
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Email:
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Affiliation:
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Chosun University Hospital |
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Name:
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Seung-jae Hong, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kyung Hee University Hospital |
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Name:
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Sangil Lee, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gyeongsang National Hospital |
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Name:
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Changnam Son, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Keimyung University Dongsan Medical Center |
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Name:
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Geun-Tae Kim, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kosin University Gospel Hospital |
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Key inclusion & exclusion 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
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: CELBESTA®
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Drug: CELEBREX® placebo
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Drug: CELBESTA® placebo
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Drug: CELEBREX®
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Primary Outcome(s)
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Change from baseline of 100mm VAS about pain in study at week 6
[Time Frame: week 6]
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Secondary Outcome(s)
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Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6
[Time Frame: week 6]
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Secondary ID(s)
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CELB_RA_IV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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