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

D

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

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®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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