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Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT03473665
Recruitment Status : Terminated (Slow recruitment)
First Posted : March 22, 2018
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Runsheng Wang, MD, MHS, Columbia University

Study Description
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Brief Summary:
This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Axial Spondyloarthritis Drug: Indomethacin Drug: Diclofenac Drug: Meloxicam Drug: Celecoxib Phase 4

Detailed Description:
Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg every 12 hours (Q12H); 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. The treatment length will be 6 weeks. Primary outcome is the change of pain score from baseline to week 4 and to week 6.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Indomethacin
Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
 Drug: Indomethacin
Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Other Names:
  • INDO
  • Indomethacin ER
Active Comparator: Diclofenac
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
 Drug: Diclofenac
Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Other Names:
  • DIC
  • Diclofenac DR
  • Voltarin
Active Comparator: Meloxicam
Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
 Drug: Meloxicam
meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Other Name: MLX
Active Comparator: Celecoxib
Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
 Drug: Celecoxib
Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Other Name: CEL


Outcome Measures
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Primary Outcome Measures :
  1. Change of Pain Score [ Time Frame: Baseline, Week 4, and Week 6 ]
    Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]


Secondary Outcome Measures :
  1. Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Week 4, and Week 6 ]
    Change of BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]

  2. Change of Bath Ankylosing Spondylitis Function Index (BASFI) [ Time Frame: Baseline, Week 4, and Week 6 ]
    Change of BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]

  3. Change of ASAS Endorsed Disease Activity Score (ASDAS) [ Time Frame: Baseline, Week 4, and Week 6 ]
    Change of ASDAS by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]

  4. Patient Global Assessment of Response to Therapy (PGART) [ Time Frame: Week 6 ]
    Likert Scale on whether effective or not.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of ankylosing spondylitis (AS) by treating rheumatologists, or a diagnosis of axial spondyloarthritis (axSpA) with a pelvis MRI with significant bone marrow edema on STIR sequences;
  • Minimum of 18 years old;
  • Are taking NSAIDs on a regular basis for AS or axSpA (defined as more than 20 days in the past month) and willing to withhold medication for one week; or having active symptoms that require initiation of NSAIDs;
  • Concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the past three months;
  • Have active disease after initial washout period, defined by BASDAI >=4/10, or back pain numerical rating scale (NRS)>=4/10

Exclusion Criteria:

  • Patients who have concurrent rheumatic diseases other than AS or axSpA;
  • Patients who have oral corticosteroid in the past two weeks; patients who have acute peripheral arthritis;
  • Patients with a fibromyalgia score >= 13;
  • Patient with extensive cardiac history, history of gastrointestinal bleeding that required blood transfusion, chronic kidney diseases, abnormal liver function tests; or female patients who are pregnant.

Use of low-dose of aspirin (<100mg daily) is allowed in the study.

Contacts and Locations
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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): NCT03473665


Locations
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United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Runsheng Wang, MD, MHS Columbia University
  Study Documents (Full-Text)

Documents provided by Runsheng Wang, MD, MHS, Columbia University:
Study Protocol and Statistical Analysis Plan  [PDF] December 18, 2018

More Information
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Responsible Party: Runsheng Wang, MD, MHS, Instructor in Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03473665    
Other Study ID Numbers: AAAR3505
First Posted: March 22, 2018    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Runsheng Wang, MD, MHS, Columbia University:
ankylosing spondylitis
spondyloarthritis
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Spondylarthropathies
Ankylosis
Celecoxib
Diclofenac
Indomethacin
 Meloxicam
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
Gout Suppressants
Tocolytic Agents