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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: CELEBREX®; Drug: CELEBREX® placebo; Drug: CELBESTA®; Drug: CELBESTA® placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02780323

CELB_RA_IV

Details and patient eligibility

About

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

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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119 participants in 2 patient groups

CELBESTA® and CELEBREX® placebo

Experimental group

Description:

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

Treatment:

Drug: CELEBREX® placebo

Drug: CELBESTA®

CELEBREX®

Active Comparator group

Description:

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

Treatment:

Drug: CELBESTA® placebo

Drug: CELEBREX®