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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780323
• Other study ID #: CELB_RA_IV
• Status: Completed
• Phase: Phase 4
• Start date: November 2, 2015
• Est. completion date: December 26, 2017

Study information

• Verified date: February 2020
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 26, 2017
• Est. primary completion date: December 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of 100mm VAS about pain in study at week 6		week 6
Secondary	Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6		week 6