Ankylosing SpondylitisPhase 4NCT03473665

Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

A Phase 4 study testing Indomethacin, Diclofenac and Meloxicam in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Columbia University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ankylosing Spondylitis, Axial Spondyloarthritis
What is being tested?: Indomethacin, Diclofenac and Meloxicam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2018to 2 Aug 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study

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: Ankylosing Spondylitis, Axial Spondyloarthritis
Being tested: Indomethacin, Diclofenac, Meloxicam, Celecoxib
Keywords: ankylosing spondylitis, spondyloarthritis
Medical subject headings: Spondylitis, Ankylosing, Axial Spondyloarthritis, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IndomethacinDrug
Also called INDO, Indomethacin ER
Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
DiclofenacDrug
Also called DIC, Diclofenac DR, Voltarin
Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
MeloxicamDrug
Also called MLX
meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
CelecoxibDrug
Also called CEL
Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Study groups in NCT03473665
Study group	Role	What they receive
Indomethacin	Active comparator	Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks Receives: Drug: Indomethacin
Diclofenac	Active comparator	Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks Receives: Drug: Diclofenac
Meloxicam	Active comparator	Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks Receives: Drug: Meloxicam
Celecoxib	Active comparator	Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks Receives: Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Pain Score
Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]
Measured: Baseline, Week 4, and Week 6

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20182 Aug 2019

First posted22 Mar 2018
Study start1 Mar 2018
Primary completion2 Aug 2019
Study completion2 Aug 2019

Why it stopped: Slow recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03473665
Sponsor's protocol ID: AAAR3505
Status last verified: Sep 2020
First submitted: 13 Mar 2018
Last updated: 22 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis

All Ankylosing Spondylitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study
ClinicalTrials.gov ID: NCT03473665
Acronym / sponsor ID: AAAR3505
Conditions: Ankylosing Spondylitis, Axial Spondyloarthritis
Keywords: ankylosing spondylitis, spondyloarthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment
Enrolment: 9 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: 1 Mar 2018 (actual)
Primary completion: 2 Aug 2019 (actual)
Study completion: 2 Aug 2019 (actual)
First posted: 22 Mar 2018 (actual)
Results: Posted 22 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IndomethacinAlso: INDO, Indomethacin ERIndomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks	Drug	Indomethacin
DiclofenacAlso: DIC, Diclofenac DR, VoltarinDiclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks	Drug	Diclofenac
MeloxicamAlso: MLXmeloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks	Drug	Meloxicam
CelecoxibAlso: CELCelecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks	Drug	Celecoxib

Primary outcome

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)]

4 secondary outcomes

Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline, Week 4, and Week 6
Change of Bath Ankylosing Spondylitis Function Index (BASFI)
Time frame: Baseline, Week 4, and Week 6
Change of ASAS Endorsed Disease Activity Score (ASDAS)
Time frame: Baseline, Week 4, and Week 6
Patient Global Assessment of Response to Therapy (PGART)
Time frame: Week 6

Results and safety

Results posted to the registry on 22 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NSAIDs	9	9

Primary outcome: Change of Pain Score

Time frame: Baseline, Week 4, and Week 6. Median (Full Range). Unit: units on a scale

Measure	NSAIDs x 4 Weeks n = 9	NSAIDs x 6 Weeks n = 9
Value	-2 (-6 to 2)	-2 (-5 to 0)

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Meloxicam	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Indomethacin	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Diclofenac	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Ankylosing Spondylitis

RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Runsheng Wang, MD, MHS principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indomethacin, Diclofenac and Meloxicam in people with Ankylosing Spondylitis and Axial Spondyloarthritis, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Pain Score (time frame: Baseline, Week 4, and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.