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

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: CELEBREX®; Drug: CELBESTA®; Drug: CELEBREX® placebo; Drug: CELBESTA® placebo

• Registration Number: NCT02780323
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Study Timeline

• Study Start: 2015-11-02
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-23
• Primary Completion: 2017-12-26
• Study Completion: 2017-12-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of