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

February 3, 2020 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CELBESTA® and CELEBREX® placebo
CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks
Drug: CELBESTA®
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
Other Names:
  • celecoxib
Drug: CELEBREX® placebo
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
Other Names:
  • celecoxib placebo
ACTIVE_COMPARATOR: CELEBREX®
CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks
Drug: CELEBREX®
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
Other Names:
  • celecoxib
Drug: CELBESTA® placebo
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
Other Names:
  • celecoxib placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: 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, Chosun university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2015

Primary Completion (ACTUAL)

December 26, 2017

Study Completion (ACTUAL)

December 26, 2017

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (ESTIMATE)

May 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELB_RA_IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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