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Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

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

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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. change of pain score [ Time Frame: at week 4 vs. at week 6 ]
    change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]


Secondary Outcome Measures :
  1. change of BASDAI [ Time Frame: at week 4 vs. at week 6 ]
    change of Bath Ankylosing Spondylitis Disease Activity Index from baseline [scale range: 0 (better) -10 (worse)]

  2. change of BASFI [ Time Frame: at week 4 vs. at week 6 ]
    change of Bath Ankylosing Spondylitis Functional Index from baseline [scale range: 0 (better) -10 (worse)]

  3. change of ASDAS [ Time Frame: at week 4 vs. at week 6 ]
    change of Ankylosing Spondylitis Disease Activity Score from baseline [composite score: 0 (no disease activity) - 6.5 (very high disease activity)]

  4. Patient Global Assessment of Response to Therapy (PGART) [ Time Frame: at week 6 ]
    patient's global assessment of effectiveness of a treatment



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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.


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


Contacts
Contact: Christopher Depender 212-305-4114 cd2686@cumc.columbia.edu
Contact: Runsheng Wang, MD, MHS 212-342-2706 rw2646@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christopher Depender    212-305-4114    cd2686@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Runsheng Wang, MD, MHS Columbia University
  Study Documents (Full-Text)

Documents provided by Runsheng Wang, MD, MHS, Columbia University:

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

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:
ankylsoing spondylitis
spondyloarthritis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis
Celecoxib
Diclofenac
Indomethacin
Meloxicam
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents