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

Primary Purpose

Spondylarthropathies, Magnetic Resonance Imaging

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
Armed Forces Capital Hospital, Republic of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylarthropathies

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Armed Forces Capital Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib arm

Arm Description

Axial Spondyloarthritis patients who takes celecoxib 400mg for day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 15, 2017
Last Updated
June 4, 2018
Sponsor
Armed Forces Capital Hospital, Republic of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03190603
Brief Title
Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis
Official Title
Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Capital Hospital, Republic of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylarthropathies, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib arm
Arm Type
Experimental
Arm Description
Axial Spondyloarthritis patients who takes celecoxib 400mg for day
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.
Primary Outcome Measure Information:
Title
Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score of sacroiliac joint
Description
Change from baseline SPARCC MRI score of sacroiliac joint at 6 weeks and 12 weeks
Time Frame
Baseline, 6 weeks after, 12 weeks after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Armed Forces Capital Hospital
City
Seongnam-si
ZIP/Postal Code
KS009
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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