Back to resultsNon-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
Primary Purpose
Ankylosing Spondylitis, Axial Spondyloarthritis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Indomethacin
Diclofenac
Meloxicam
Celecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, spondyloarthritis
Eligibility 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.
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Indomethacin
Diclofenac
Meloxicam
Celecoxib
Arm Description
Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
Outcomes
Primary Outcome Measures
Change of Pain Score
Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Secondary Outcome Measures
Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Change of BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Change of Bath Ankylosing Spondylitis Function Index (BASFI)
Change of BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Change of ASAS Endorsed Disease Activity Score (ASDAS)
Change of ASDAS by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Patient Global Assessment of Response to Therapy (PGART)
Likert Scale on whether effective or not.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03473665
Brief Title
Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
Official Title
Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis, Axial Spondyloarthritis
Keywords
ankylosing spondylitis, spondyloarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indomethacin
Arm Type
Active Comparator
Arm Description
Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Description
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Arm Title
Meloxicam
Arm Type
Active Comparator
Arm Description
Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
Arm Title
Celecoxib
Arm Type
Active Comparator
Arm Description
Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Other Intervention Name(s)
INDO, Indomethacin ER
Intervention Description
Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
DIC, Diclofenac DR, Voltarin
Intervention Description
Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Other Intervention Name(s)
MLX
Intervention Description
meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
CEL
Intervention Description
Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Primary Outcome Measure Information:
Title
Change of Pain Score
Description
Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame
Baseline, Week 4, and Week 6
Secondary Outcome Measure Information:
Title
Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
Change of BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame
Baseline, Week 4, and Week 6
Title
Change of Bath Ankylosing Spondylitis Function Index (BASFI)
Description
Change of BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame
Baseline, Week 4, and Week 6
Title
Change of ASAS Endorsed Disease Activity Score (ASDAS)
Description
Change of ASDAS by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Time Frame
Baseline, Week 4, and Week 6
Title
Patient Global Assessment of Response to Therapy (PGART)
Description
Likert Scale on whether effective or not.
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runsheng Wang, MD, MHS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
We'll reach out to this number within 24 hrs