Rheumatoid ArthritisPhase 4NCT02780323
Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis
A Phase 4 study testing CELBESTA® and CELEBREX® in people with Rheumatoid Arthritis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CELBESTA® and CELEBREX®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2015to 26 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
This Phase IV clinical study is to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Rheumatoid Arthritis Patients
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CELBESTA®, CELEBREX®, CELEBREX® placebo, CELBESTA® placebo
- Keywords
- Celecoxib, CELBESTA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELBESTA®Drug
Also called celecoxib
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
CELEBREX®Drug
Also called celecoxib
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
CELEBREX® placeboDrug
Also called celecoxib placebo
1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
CELBESTA® placeboDrug
Also called celecoxib placebo
1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| CELBESTA® and CELEBREX® placebo | Experimental | CELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks Receives: Drug: CELBESTA®; Drug: CELEBREX® placebo |
| CELEBREX® | Active comparator | CELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks Receives: Drug: CELEBREX®; Drug: CELBESTA® placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of 100mm VAS about pain in study at week 6
Measured: week 6
Secondary outcomes (1)
Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start2 Nov 2015
- Primary completion26 Dec 2017
- Study completion26 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung-jae Hong, MD,PhD, Principal investigator, Kyung Hee University HospitalSungsoo Kim, MD,PhD, Principal investigator, Gangneung Asan HospitalSangil Lee, MD,PhD, Principal investigator, Gyeongsang National HospitalChangnam Son, MD,PhD, Principal investigator, Keimyung University Dongsan Medical CenterYeong Ho Seo, MD,PhD, Principal investigator, Korea UniversityGeun-Tae Kim, MD,PhD, Principal investigator, Kosin University Gospel HospitalJin-Wuk Hur, MD,PhD, Principal investigator, Seoul Eulji HospitalHyun-Sook Kim, MD,PhD, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780323
- Sponsor's protocol ID
- CELB_RA_IV
- Status last verified
- Feb 2020
- First submitted
- 19 May 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02780323
- Acronym / sponsor ID
- CELB_RA_IV
- Conditions
- Rheumatoid Arthritis
- Keywords
- Celecoxib, CELBESTA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 26 Dec 2017 (actual)
- Study completion
- 26 Dec 2017 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CELBESTA® and CELEBREX® placebo | Experimental | Drug: CELBESTA®, Drug: CELEBREX® placeboCELBESTA® and CELEBREX® placebo is administered twice daily for 6 weeks |
| CELEBREX® | Active comparator | Drug: CELEBREX®, Drug: CELBESTA® placeboCELEBREX® and CELBESTA® placebo is administered twice daily for 6 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CELBESTA®Also: celecoxib1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks | Drug | CELBESTA® and CELEBREX® placebo |
| CELEBREX®Also: celecoxib1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks | Drug | CELEBREX® |
| CELEBREX® placeboAlso: celecoxib placebo1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks | Drug | CELBESTA® and CELEBREX® placebo |
| CELBESTA® placeboAlso: celecoxib placebo1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks | Drug | CELEBREX® |
Primary outcome
Change from baseline of 100mm VAS about pain in study at week 6
Time frame: week 6
1 secondary outcome
Change from baseline of DAS28-ESR(Disease Activity Score in 28 joints) at week 6
Time frame: week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-jae Hong, MD,PhD principal investigator
Kyung Hee University Hospital
Sungsoo Kim, MD,PhD principal investigator
Gangneung Asan Hospital
Sangil Lee, MD,PhD principal investigator
Gyeongsang National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CELBESTA® and CELEBREX® in people with Rheumatoid Arthritis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of 100mm VAS about pain in study at week 6 (time frame: week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.