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

NCT03190603 | Completed Phase 4 DMC

• 1 other identifier: Hong Ki Min
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylarthropathies; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Celecoxib arm

EXPERIMENTAL

Axial Spondyloarthritis patients who takes celecoxib 400mg for day

Drug: Celecoxib

Interventions

Celecoxib DRUG

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

Celecoxib arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armed Forces Capital Hospital, Republic of Korea: lead

Study Sites (1)

Armed Forces Capital Hospital

Seongnam-si, KS009, South Korea

Location

MeSH Terms

Conditions

Spondylarthropathies

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: June 1, 2018
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)