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Completed

NCT Number: NCT02780323

Study 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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyung Hee University Hospital

Seoul, 130-702, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CELBESTA®

Drug

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

Other names: celecoxib

CELEBREX®

Drug

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

Other names: celecoxib

CELEBREX® placebo

Drug

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

Other names: celecoxib placebo

CELBESTA® placebo

Drug

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

Other names: celecoxib placebo

Primary outcomes

  1. Change from baseline of 100mm VAS about pain in study at week 6

    Time frame: week 6

Secondary outcomes

  1. Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6

    Time frame: week 6

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 23, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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