Axial SpondyloarthritisPhase 2NCT04115098
Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
A Phase 2 study testing Celecoxib, Naproxen and Meloxicam in people with Axial Spondyloarthritis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare selective COX-2 and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Celecoxib, Naproxen and Meloxicam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 11 Aug 2023
- Phase
- Phase 2
- 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
- Patients must meet modified New York Classification and/or Assessment of Spondyloarthritis International Society (ASAS) criteria for Classification Criteria for AxSpA
- Ankylosing Spondylitis Disease Activity Score greater than or equal to 2.1.
Who cannot join
- Changing background biologic/disease modifying-rheumatic medications within less than 3 months.
- Opioid medication use
- Current or expected pregnancy
- History of cardiovascular disease (previous stroke, myocardial infarction, or percutaneous intervention.
- End stage liver disease
- Chronic Kidney Disease greater than Stage IIIb
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare selective COX-2 and nonselective COX inhibitors impact on Health related Quality of Life (HrQOL) and how this relates to changes in disease activity and to conduct proteomic assessment of predictive biomarkers of non steroidal anti-inflammatory drug(NSAID) response
- Conditions
- Axial Spondyloarthritis
- Being tested
- Celecoxib, Naproxen, Meloxicam
- Keywords
- spondylitis
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
NaproxenDrug
Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
MeloxicamDrug
Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Celecoxib, Then Meloxicam, Then Naproxen, Then B, Then A | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Celecoxib, Then Naproxen, Then Meloxicam, Then A, Then B | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Celecoxib, Then Naproxen, Then Meloxicam, Then B, Then A | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Meloxicam, Then Celecoxib, Then Naproxen, Then A, Then B | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Meloxicam, Then Celecoxib, Then Naproxen, Then B, Then A | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Meloxicam, Then Naproxen, Then Celecoxib, Then A, Then B | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Naproxen, Then Celecoxib, Then Meloxicam, Then A, Then B | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Naproxen, Then Celecoxib, Then Meloxicam, Then B, Then A | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Naproxen, Then Meloxicam, Then Celecoxib, Then A, Then B | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
| Naproxen, Then Meloxicam, Then Celecoxib, Then B, Then A | Experimental | Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. Receives: Drug: Celecoxib; Drug: Naproxen; Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS total score ranges from 0-10, with a higher score meaning worse disease activity. The change in score is reported as [(ASDAS score at baseline) - (ASDAS score at 4 weeks)]--a positive value indicates that the score (and disease activity) decreased over time.
The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Measured: Baseline, 4 weeks
Secondary outcomes (7)
Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment
The Standard Gamble Utility assessment is scored between 0-1, with 0 being the worst outcome and 1 being the best outcome. The change in score is reported as [(Standard Gamble score at baseline) - (Standard Gamble score at 4 weeks)]--a negative value indicates that the Health Related Quality of Life increased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval.
Measured: Baseline, 4 weeks
Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score
The reported Patient-Reported Outcomes Measurement Information System-Preference (PROPr) Score ranges from 0 to 1, with 0 being the worst outcome and 1 being the best outcome. The change in score is reported as [(PROPr score at baseline) - (PROPR score at 4 weeks)] - a negative value indicates that the person's Health Related Quality of Life increased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Measured: Baseline, 4 weeks
Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges from 0-10, with 0 being easy and 10 being impossible. The change in score is reported as [(BASFI score at baseline) - (BASFI score at 4 weeks)], and a positive value indicates that the score (and difficulty with tasks) decreased over time.
The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Measured: Baseline, 4 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem). The change in score is reported as [(BASDAI score at baseline) - (BASDAI score at 4 weeks)] -- a positive value indicates that the score (and disease activity) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Measured: Baseline, 4 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI total score ranges from 0 - 10.The higher the BASMI score, the more severe the patient's limitation of movement due to their ankylosing spondylitis. The change in score is reported as [(BASMI score at baseline) - (BASMI score at 4 weeks)]--a positive value indicates that the score (and limitation of movement) decreased over time.
The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Measured: Baseline, 4 weeks
Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS-Pain total score is 0 - 100, with 0 being no pain and 100 being unbearable pain. The change in score is reported as [(VAS- Pain score at baseline) - (VAS- Pain score at 4 weeks)] --a positive value indicates that the score (and pain level) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Measured: Baseline, 4 weeks
Change in Visual Analog Scale-Global (VAS-Global)
The VAS-Global is scored from 0-100, with 0 being not active and 100 being very active. The change in score is reported as [(VAS- Global score at baseline) - (VAS- Global score at 4 weeks)] --a negative value indicates that the score (and activity level) increased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start25 Jun 2020
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Why it stopped: lack of 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Mark C Hwang, The University of Texas Health Science Center, Houston
- Investigators
- Mark C Hwang, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115098
- Sponsor's protocol ID
- HSC-MS-19-0677
- Other IDs
- KL2TR003168
- Status last verified
- Aug 2025
- First submitted
- 2 Oct 2019
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang MC, Kim S, Assassi S, Chavez R, Samuel J, Green C, Tyson J, Reveille J. Individualizing NSAID therapy in axial spondyloarthritis: N-of-1 trials with Bayesian analysis. Rheumatology (Oxford). 2025 Dec 1;64(12):6114-6121. doi: 10.1093/rheumatology/keaf393.
PubMed 40676732
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
- ClinicalTrials.gov ID
- NCT04115098
- Acronym / sponsor ID
- HSC-MS-19-0677
- Conditions
- Axial Spondyloarthritis
- Keywords
- spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 4 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare selective COX-2 and nonselective COX inhibitors impact on Health related Quality of Life (HrQOL) and how this relates to changes in disease activity and to conduct proteomic assessment of predictive biomarkers of non steroidal anti-inflammatory drug(NSAID) response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Celecoxib, Then Meloxicam, Then Naproxen, Then B, Then A | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Celecoxib, Then Naproxen, Then Meloxicam, Then A, Then B | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Celecoxib, Then Naproxen, Then Meloxicam, Then B, Then A | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Meloxicam, Then Celecoxib, Then Naproxen, Then A, Then B | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Meloxicam, Then Celecoxib, Then Naproxen, Then B, Then A | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Meloxicam, Then Naproxen, Then Celecoxib, Then A, Then B | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Naproxen, Then Celecoxib, Then Meloxicam, Then A, Then B | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Naproxen, Then Celecoxib, Then Meloxicam, Then B, Then A | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Naproxen, Then Meloxicam, Then Celecoxib, Then A, Then B | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
| Naproxen, Then Meloxicam, Then Celecoxib, Then B, Then A | Experimental | Drug: Celecoxib, Drug: Naproxen, Drug: MeloxicamEach participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions [randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must meet modified New York Classification and/or Assessment of Spondyloarthritis International Society (ASAS) criteria for Classification Criteria for AxSpA
- Ankylosing Spondylitis Disease Activity Score greater than or equal to 2.1.
Key exclusion criteria (6 listed)
- Changing background biologic/disease modifying-rheumatic medications within less than 3 months.
- Opioid medication use
- Current or expected pregnancy
- History of cardiovascular disease (previous stroke, myocardial infarction, or percutaneous intervention.
- End stage liver disease
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 |
|---|---|---|
| CelecoxibCelecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules | Drug | Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B, Celecoxib, Then Meloxicam, Then Naproxen, Then B, Then A, Celecoxib, Then Naproxen, Then Meloxicam, Then A, Then B, Celecoxib, Then Naproxen, Then Meloxicam, Then B, Then A, Meloxicam, Then Celecoxib, Then Naproxen, Then A, Then B, Meloxicam, Then Celecoxib, Then Naproxen, Then B, Then A, Meloxicam, Then Naproxen, Then Celecoxib, Then A, Then B, Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A, Naproxen, Then Celecoxib, Then Meloxicam, Then A, Then B, Naproxen, Then Celecoxib, Then Meloxicam, Then B, Then A, Naproxen, Then Meloxicam, Then Celecoxib, Then A, Then B, Naproxen, Then Meloxicam, Then Celecoxib, Then B, Then A |
| NaproxenNaproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules | Drug | Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B, Celecoxib, Then Meloxicam, Then Naproxen, Then B, Then A, Celecoxib, Then Naproxen, Then Meloxicam, Then A, Then B, Celecoxib, Then Naproxen, Then Meloxicam, Then B, Then A, Meloxicam, Then Celecoxib, Then Naproxen, Then A, Then B, Meloxicam, Then Celecoxib, Then Naproxen, Then B, Then A, Meloxicam, Then Naproxen, Then Celecoxib, Then A, Then B, Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A, Naproxen, Then Celecoxib, Then Meloxicam, Then A, Then B, Naproxen, Then Celecoxib, Then Meloxicam, Then B, Then A, Naproxen, Then Meloxicam, Then Celecoxib, Then A, Then B, Naproxen, Then Meloxicam, Then Celecoxib, Then B, Then A |
| MeloxicamMeloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules | Drug | Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B, Celecoxib, Then Meloxicam, Then Naproxen, Then B, Then A, Celecoxib, Then Naproxen, Then Meloxicam, Then A, Then B, Celecoxib, Then Naproxen, Then Meloxicam, Then B, Then A, Meloxicam, Then Celecoxib, Then Naproxen, Then A, Then B, Meloxicam, Then Celecoxib, Then Naproxen, Then B, Then A, Meloxicam, Then Naproxen, Then Celecoxib, Then A, Then B, Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A, Naproxen, Then Celecoxib, Then Meloxicam, Then A, Then B, Naproxen, Then Celecoxib, Then Meloxicam, Then B, Then A, Naproxen, Then Meloxicam, Then Celecoxib, Then A, Then B, Naproxen, Then Meloxicam, Then Celecoxib, Then B, Then A |
Primary outcome
Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Baseline, 4 weeks
The ASDAS total score ranges from 0-10, with a higher score meaning worse disease activity. The change in score is reported as [(ASDAS score at baseline) - (ASDAS score at 4 weeks)]--a positive value indicates that the score (and disease activity) decreased over time. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
7 secondary outcomes
Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment
Time frame: Baseline, 4 weeks
Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score
Time frame: Baseline, 4 weeks
Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline, 4 weeks
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline, 4 weeks
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Baseline, 4 weeks
Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain)
Time frame: Baseline, 4 weeks
Change in Visual Analog Scale-Global (VAS-Global)
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40676732Hwang MC, Kim S, Assassi S, Chavez R, Samuel J, Green C, Tyson J, Reveille J. Individualizing NSAID therapy in axial spondyloarthritis: N-of-1 trials with Bayesian analysis. Rheumatology (Oxford). 2025 Dec 1;64(12):6114-6121. doi: 10.1093/rheumatology/keaf393.
- Individual participant dataSharing planned: No
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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.
Mark C Hwang, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib, Naproxen and Meloxicam in people with Axial Spondyloarthritis, run by The University of Texas Health Science Center, Houston 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 2 inclusion and 6 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 13 Aug 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Sep 2024). 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 in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS) (time frame: Baseline, 4 weeks). 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 NCT04115098, which also lists 1 linked publication.
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 13 Aug 2025.