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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

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE March 22, 2018
Results First Submitted Date  ICMJE July 15, 2020
Results First Posted Date  ICMJE September 22, 2020
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date August 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
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)]
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
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)]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
  • 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)]
  • 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)]
  • 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)]
  • Patient Global Assessment of Response to Therapy (PGART) [ Time Frame: Week 6 ]
    Likert Scale on whether effective or not.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • 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)]
  • 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)]
  • 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)]
  • Patient Global Assessment of Response to Therapy (PGART) [ Time Frame: at week 6 ]
    Patient's global assessment of effectiveness of a treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
Official Title  ICMJE Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ankylosing Spondylitis
  • Axial Spondyloarthritis
Intervention  ICMJE
  • 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
  • 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
  • Drug: Meloxicam
    meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
    Other Name: MLX
  • Drug: Celecoxib
    Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
    Other Name: CEL
Study Arms  ICMJE
  • Active Comparator: Indomethacin
    Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
    Intervention: Drug: Indomethacin
  • Active Comparator: Diclofenac
    Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
    Intervention: Drug: Diclofenac
  • Active Comparator: Meloxicam
    Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
    Intervention: Drug: Meloxicam
  • Active Comparator: Celecoxib
    Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
    Intervention: Drug: Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 15, 2020)
9
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
30
Actual Study Completion Date  ICMJE August 2, 2019
Actual Primary Completion Date August 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03473665
Other Study ID Numbers  ICMJE AAAR3505
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Runsheng Wang, MD, MHS, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Runsheng Wang, MD, MHS Columbia University
PRS Account Columbia University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP