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NCT03190603 Clinical Trial

Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis

Magnetic Resonance Imaging Clinical Trial

Official title:
Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03190603
Other study ID # Hong Ki Min
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 1, 2018
Est. completion date June 5, 2018

Study information
Verified date June 2018
Source Armed Forces Capital Hospital, Republic of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 5, 2018
Est. primary completion date June 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

1. 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis

2. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4

3. definite bone marrow edema on Sacroiliac joint MRI

Exclusion Criteria:

1. Patients who have underling cancer / infectious disease / kidney disease / liver disease / cardiovascular or cerebrovascular disease

2. Patients who is using TNF-a inhibitor

3. Patients with side effects of NSAID

4. Patients with history of peptic ulcer

5. Patients who can't keep NSAID treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Celecoxib
Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.

Locations
Country Name City State
Korea, Republic of Armed Forces Capital Hospital Seongnam-si

Sponsors (1)
Lead Sponsor Collaborator
Armed Forces Capital Hospital, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Baseline, 6 weeks after, 12 weeks after
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