SpondylarthropathiesPhase 4NCT03190603
Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis
A Phase 4 study testing Celecoxib in people with Spondylarthropathies and Magnetic Resonance Imaging, run by Armed Forces Capital Hospital, Republic of Korea at 1 site in South Korea.
Trial summary
Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness, peripheral arthritis, enthesitis. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Spondylarthropathies, Magnetic Resonance Imaging
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2018to 5 Jun 2018
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4
- definite bone marrow edema on Sacroiliac joint MRI
Who cannot join
- Patients who have underling cancer / infectious disease / kidney disease / liver disease / cardiovascular or cerebrovascular disease
- Patients who is using TNF-a inhibitor
- Patients with side effects of NSAID
- Patients with history of peptic ulcer
- Patients who can't keep NSAID treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding
Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness, peripheral arthritis, enthesitis. Controlling aforementioned symptoms are one of the goal in treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine. Ankylosis can limit range of motion and lower the quality of life.
Non-steroidal antiinflammatory drug (NSAID) and Tumor necrosis factor (TNF)-a inhibitor are the current treatment options for axial SpA. These medications can improve pain and stiffness of axial SpA patients, however preventing bony ankylosis is not proven. Current study showed attenuating inflammation at early stage could prevent further bony destruction and ankylosis in axial SpA. Present study is designed to discover the therapeutic effect of NSAID whether NSAID could recover the early inflammatory bony change (bone marrow edema at MRI) and prevent further bony change.
- Conditions
- Spondylarthropathies, Magnetic Resonance Imaging
- Being tested
- Celecoxib
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib arm | Experimental | Axial Spondyloarthritis patients who takes celecoxib 400mg for day Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score of sacroiliac joint
Change from baseline SPARCC MRI score of sacroiliac joint at 6 weeks and 12 weeks
Measured: Baseline, 6 weeks after, 12 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Jun 2018
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthropathiesStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Capital Hospital, Republic of Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hong Ki Min, Armed Forces Capital Hospital, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190603
- Sponsor's protocol ID
- Hong Ki Min
- Status last verified
- Jun 2018
- First submitted
- 15 Jun 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding
- ClinicalTrials.gov ID
- NCT03190603
- Acronym / sponsor ID
- Hong Ki Min
- Conditions
- Spondylarthropathies, Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Armed Forces Capital Hospital, Republic of KoreaOther government
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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.
Axial Spondyloarthritis (SpA) is a kind of inflammatory arthritis which includes ankylosing spondylitis. Common symptoms of axial SpA are inflammatory back pain, morning stiffness, peripheral arthritis, enthesitis. Controlling aforementioned symptoms are one of the goal in treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine. Ankylosis can limit range of motion and lower the quality of life.
Non-steroidal antiinflammatory drug (NSAID) and Tumor necrosis factor (TNF)-a inhibitor are the current treatment options for axial SpA. These medications can improve pain and stiffness of axial SpA patients, however preventing bony ankylosis is not proven. Current study showed attenuating inflammation at early stage could prevent further bony destruction and ankylosis in axial SpA. Present study is designed to discover the therapeutic effect of NSAID whether NSAID could recover the early inflammatory bony change (bone marrow edema at MRI) and prevent further bony change.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib arm | Experimental | Drug: CelecoxibAxial Spondyloarthritis patients who takes celecoxib 400mg for day |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4
- definite bone marrow edema on Sacroiliac joint MRI
Key exclusion criteria (5 listed)
- Patients who have underling cancer / infectious disease / kidney disease / liver disease / cardiovascular or cerebrovascular disease
- Patients who is using TNF-a inhibitor
- Patients with side effects of NSAID
- Patients with history of peptic ulcer
- Patients who can't keep NSAID treatment
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 |
|---|---|---|
| CelecoxibContinue celecoxib 400mg/day for 3months in axial spondyloarthritis patients. | Drug | Celecoxib arm |
Primary outcome
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score of sacroiliac joint
Time frame: Baseline, 6 weeks after, 12 weeks after
Change from baseline SPARCC MRI score of sacroiliac joint at 6 weeks and 12 weeks
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 6 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Celecoxib in people with Spondylarthropathies and Magnetic Resonance Imaging, run by Armed Forces Capital Hospital, Republic of Korea 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 3 inclusion and 5 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 6 Jun 2018. 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?
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score of sacroiliac joint (time frame: Baseline, 6 weeks after, 12 weeks after). 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 6 Jun 2018.