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

NCT02780323 | Completed Phase 4

• 1 other identifier: CELB_RA_IV
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Celecoxib; CELBESTA

Outcome Measures

Primary Outcomes (1)

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

  week 6

Secondary Outcomes (1)

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

  week 6

Study Arms (2)

CELBESTA® and CELEBREX® placebo

EXPERIMENTAL

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

Drug: CELBESTA®; Drug: CELEBREX® placebo

CELEBREX®

ACTIVE COMPARATOR

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

Drug: CELEBREX®; Drug: CELBESTA® placebo

Interventions

CELBESTA® DRUG

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

Also known as: celecoxib

CELBESTA® and CELEBREX® placebo

CELEBREX® DRUG

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

Also known as: celecoxib

CELEBREX®

CELEBREX® placebo DRUG

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

Also known as: celecoxib placebo

CELBESTA® and CELEBREX® placebo

CELBESTA® placebo DRUG

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

Also known as: celecoxib placebo

CELEBREX®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, 130-702, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Seung-jae Hong, MD,PhD

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

• Sungsoo Kim, MD,PhD

  Gangneung Asan Hospital

  PRINCIPAL INVESTIGATOR

• Sangil Lee, MD,PhD

  Gyeongsang National Hospital

  PRINCIPAL INVESTIGATOR

• Changnam Son, MD,PhD

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

• Yeong Ho Seo, MD,PhD

  Korea University

  PRINCIPAL INVESTIGATOR

• Geun-Tae Kim, MD,PhD

  Kosin University Gospel Hospital

  PRINCIPAL INVESTIGATOR

• Jin-Wuk Hur, MD,PhD

  Seoul Eulji Hospital

  PRINCIPAL INVESTIGATOR

• Hyun-Sook Kim, MD,PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

• Myeong Soo Lee, MD,PhD

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

• Yun Sung Kim, MD,PhD

  Chosun University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 23, 2016
• Study Start: November 2, 2015
• Primary Completion: December 26, 2017
• Study Completion: December 26, 2017
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)