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

This study is currently recruiting participants.
Verified August 2017 by Dong-A ST Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780323
First Posted: May 23, 2016
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
  Purpose
This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients

Condition Intervention Phase
Rheumatoid Arthritis Drug: CELBESTA® Drug: CELEBREX® Drug: CELEBREX® placebo Drug: CELBESTA® placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Change from baseline of 100mm VAS about pain in study at week 6 [ Time Frame: week 6 ]

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

Estimated Enrollment: 158
Study Start Date: October 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: celecoxib
Drug: CELEBREX® placebo
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
Other Name: 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 Name: celecoxib
Drug: CELBESTA® placebo
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
Other Name: celecoxib placebo

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780323


Contacts
Contact: Seung-jae Hong, MD,PhD +82-2-958-8200 hsj718@hanmail.net
Contact: Mihwa Han, Bachelor +82-2-958-8087 bfhan68@gmail.com

Locations
Korea, Republic of
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 130-702
Contact: Sohyun Park, Bachelor    +82-2-958-8087    pppp14v@gmail.com   
Sponsors and Collaborators
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
  More Information

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02780323     History of Changes
Other Study ID Numbers: CELB_RA_IV
First Submitted: May 19, 2016
First Posted: May 23, 2016
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dong-A ST Co., Ltd.:
Celecoxib
CELBESTA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents