TerminatedNCT03473665Updated Sep 22, 2020Results posted

Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

A Phase 4 interventional study of Indomethacin and Diclofenac in Ankylosing Spondylitis and Axial Spondyloarthritis, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-22.

Sponsored by Columbia University · Phase 4, Interventional, and Treatment

Why this study was terminated

Slow recruitment

Phase: Phase 4
Study type: Interventional
Enrollment: 9
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Ankylosing Spondylitis
Axial Spondyloarthritis

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Keywords

ankylosing spondylitis
spondyloarthritis

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 9 participants (actual)

Study arms

Active comparator
Indomethacin
Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Drug: Indomethacin
Active comparator
Diclofenac
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
Drug: Diclofenac
Active comparator
Meloxicam
Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
Drug: Meloxicam
Active comparator
Celecoxib
Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
Drug: Celecoxib

Interventions

DrugIndomethacin
Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Also known as: INDO, Indomethacin ER
DrugDiclofenac
Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Also known as: DIC, Diclofenac DR, Voltarin
DrugMeloxicam
meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Also known as: MLX
DrugCelecoxib
Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Also known as: CEL

What researchers measure

Primary outcomes

Change of Pain Score
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 outcomes

Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Change of BASDAI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Time frame: Baseline, Week 4, and Week 6
Change of Bath Ankylosing Spondylitis Function Index (BASFI)
Change of BASFI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Time frame: Baseline, Week 4, and Week 6
Change of ASAS Endorsed Disease Activity Score (ASDAS)
Change of ASDAS by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Time frame: Baseline, Week 4, and Week 6
Patient Global Assessment of Response to Therapy (PGART)
Likert Scale on whether effective or not.
Time frame: Week 6

Results

Posted Sep 22, 2020

Participant flow

Participant flow — Overall Study
Milestone	NSAIDs
Started	9
Completed	9
Not completed	0

Outcome measures

PrimaryChange of Pain Score

Change of pain score by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]

Time frame:: Baseline, Week 4, and Week 6
Reported as:: Median · units on a scale

Change of Pain Score
units on a scale	NSAIDs x 4 Weeks	NSAIDs x 6 Weeks
Change of Pain Score	-2 (-6 to 2)	-2 (-5 to 0)

SecondaryChange of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Change of BASDAI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]

Time frame:: Baseline, Week 4, and Week 6
Reported as:: Median · units on a scale

Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
units on a scale	NSAIDs x 4 Weeks	NSAIDs x 6 Weeks
Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-1.7 (-6.08 to 0.48)	-2.09 (-5.05 to 0.48)

SecondaryChange of Bath Ankylosing Spondylitis Function Index (BASFI)

Change of BASFI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]

Time frame:: Baseline, Week 4, and Week 6
Reported as:: Median · units on a scale

Change of Bath Ankylosing Spondylitis Function Index (BASFI)
units on a scale	NSAIDs x 4 Weeks	NSAIDs x 6 Weeks
Change of Bath Ankylosing Spondylitis Function Index (BASFI)	-0.8 (-5.8 to 1.7)	-1.2 (-4.2 to 0.4)

SecondaryChange of ASAS Endorsed Disease Activity Score (ASDAS)

Change of ASDAS by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]

Time frame:: Baseline, Week 4, and Week 6
Reported as:: Median · units on a scale

Change of ASAS Endorsed Disease Activity Score (ASDAS)
units on a scale	NSAIDs x 4 Weeks	NSAIDs x 6 Weeks
Change of ASAS Endorsed Disease Activity Score (ASDAS)	-0.37 (-1.44 to 0.29)	-0.84 (-1.58 to -0.01)

SecondaryPatient Global Assessment of Response to Therapy (PGART)

Likert Scale on whether effective or not.

Time frame:: Week 6
Reported as:: Count of participants · Participants

Patient Global Assessment of Response to Therapy (PGART)
Participants	NSAIDs x 6 Weeks
Strongly Disagree	0
Somewhat Disagree	0
Neutral	2
Somewhat Agree	3
Strongly Agree	4

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Celecoxib	0/3 (0%)	0/3 (0%)	1/3 (33.3%)
Meloxicam	0/2 (0%)	0/2 (0%)	1/2 (50%)
Indomethacin	0/2 (0%)	0/2 (0%)	2/2 (100%)
Diclofenac	0/2 (0%)	0/2 (0%)	1/2 (50%)

Most frequent other events

Most frequent other events
Event	Celecoxib	Meloxicam	Indomethacin	Diclofenac
diarrheaGastrointestinal disorders	1/3	1/2	1/2	0/2
constipationGastrointestinal disorders	0/3	0/2	1/2	0/2
dizzinessNervous system disorders	1/3	0/2	1/2	0/2
HeadacheNervous system disorders	0/3	1/2	0/2	0/2
Shortness of BreathRespiratory, thoracic and mediastinal disorders	0/3	0/2	0/2	1/2
hematuriaRenal and urinary disorders	0/3	0/2	1/2	0/2

Baseline characteristics

This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.

Age, Categorical
Age, Categorical(Participants)	NSAIDs
<=18 years	0
Between 18 and 65 years	9
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	NSAIDs
Female	4
Male	5

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	NSAIDs

Pain
Pain(units on a scale)	NSAIDs
Median	6 (3 to 8)

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(units on a scale)	NSAIDs
Median	4.9 (1 to 7.65)

Bath Ankylosing Spondylitis Function Index (BASFI)
Bath Ankylosing Spondylitis Function Index (BASFI)(units on a scale)	NSAIDs
Median	3.7 (0.4 to 8.4)

ASAS Endorsed Disease Activity Score (ASDAS)
ASAS Endorsed Disease Activity Score (ASDAS)(units on a scale)	NSAIDs
Median	3.34 (2.03 to 4.79)

Study locations

1 site

Columbia University Irving Medical Center
New York, New York 10032, United States

References and documents

Study documents

Protocol and statistical analysis plan · Dec 18, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03473665
Lead sponsor: Columbia University
Responsible party: Runsheng Wang, MD, MHS (Instructor in Medicine, Columbia University) — Principal investigator
First posted: Mar 22, 2018
Start date: Mar 1, 2018
Primary completion: Aug 2, 2019
Completion: Aug 2, 2019
Results posted: Sep 22, 2020
Last update: Sep 22, 2020

Study contacts

Runsheng Wang, MD, MHS

principal investigator · Columbia University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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