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Completed

NCT Number: NCT03190603

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

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.

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Key information

Conditions

Spondylarthropathies Arthritis Bone Diseases Joint Diseases Magnetic Resonance Imaging Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Armed Forces Capital Hospital

Seongnam-si, KS009, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Armed Forces Capital Hospital, Republic of Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2017
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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