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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 26, 2017

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.

Interventions

  • Drug: CELBESTA®
    • 1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
  • Drug: CELEBREX®
    • 1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
  • Drug: CELEBREX® placebo
    • 1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
  • Drug: CELBESTA® placebo
    • 1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks

Arms, Groups and Cohorts

  • Experimental: CELBESTA® and CELEBREX® placebo
    • CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks
  • Active Comparator: CELEBREX®
    • CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline of 100mm VAS about pain in study at week 6
    • Time Frame: week 6

Secondary Measures

  • Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6
    • Time Frame: week 6

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dong-A ST Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seung-jae Hong, MD,PhD, Principal Investigator, Kyung Hee University Hospital
    • Sungsoo Kim, MD,PhD, Principal Investigator, Gangneung Asan Hospital
    • Sangil Lee, MD,PhD, Principal Investigator, Gyeongsang National Hospital
    • Changnam Son, MD,PhD, Principal Investigator, Keimyung University Dongsan Medical Center
    • Yeong Ho Seo, MD,PhD, Principal Investigator, Korea University
    • Geun-Tae Kim, MD,PhD, Principal Investigator, Kosin University Gospel Hospital
    • Jin-Wuk Hur, MD,PhD, Principal Investigator, Seoul Eulji Hospital
    • Hyun-Sook Kim, MD,PhD, Principal Investigator, Soonchunhyang University Hospital
    • Myeong Soo Lee, MD,PhD, Principal Investigator, Wonkwang University Hospital
    • Yun Sung Kim, MD,PhD, Principal Investigator, Chosun University Hospital

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