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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03190603
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hong Ki Min, Armed Forces Capital Hospital, Republic of Korea

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.


Condition or disease Intervention/treatment Phase
Spondylarthropathies Magnetic Resonance Imaging Drug: Celecoxib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Nonsteroidal Anti-inflammatory Drug (NSAID) on Inflammatory Lesion of Axial Spondyloarthritis Results From MRI Finding
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celecoxib arm
Axial Spondyloarthritis patients who takes celecoxib 400mg for day
Drug: Celecoxib
Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190603


Locations
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Korea, Republic of
Armed Forces Capital Hospital
Seongnam-si, Korea, Republic of, KS009
Sponsors and Collaborators
Armed Forces Capital Hospital, Republic of Korea
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Responsible Party: Hong Ki Min, M.D., Armed Forces Capital Hospital, Republic of Korea
ClinicalTrials.gov Identifier: NCT03190603    
Other Study ID Numbers: Hong Ki Min
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylarthritis
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action