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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CELBESTA®

CELEBREX®

CELEBREX® placebo

CELBESTA® placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Celecoxib, CELBESTA

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CELBESTA® and CELEBREX® placebo

CELEBREX®

Arm Description

CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks

CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02780323

First Posted

May 19, 2016

Last Updated

February 3, 2020

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02780323

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

November 2, 2015 (Actual)

Primary Completion Date

December 26, 2017 (Actual)

Study Completion Date

December 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Celecoxib, CELBESTA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CELBESTA® and CELEBREX® placebo

Arm Type

Experimental

Arm Description

CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks

Arm Title

CELEBREX®

Arm Type

Active Comparator

Arm Description

CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks

Intervention Type

Drug

Intervention Name(s)

CELBESTA®

Other Intervention Name(s)

celecoxib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CELEBREX®

Other Intervention Name(s)

celecoxib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CELEBREX® placebo

Other Intervention Name(s)

celecoxib placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CELBESTA® placebo

Other Intervention Name(s)

celecoxib placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

week 6

Secondary Outcome Measure Information:

Title

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

Time Frame

week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: