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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR003168 | U.S. NIH Grant/Contract | View source |
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lack of recruitment
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark C Hwang, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40676732 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B | 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. |
| FG001 | Celecoxib, Then Meloxicam, Then Naproxen, Then B, Then A | 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. |
| FG002 | Celecoxib, Then Naproxen, Then Meloxicam, Then A, Then B | 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. |
| FG003 | Celecoxib, Then Naproxen, Then Meloxicam, Then B, Then A | 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. |
| FG004 | Meloxicam, Then Celecoxib, Then Naproxen, Then A, Then B | 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. |
| FG005 | Meloxicam, Then Celecoxib, Then Naproxen, Then B, Then A | 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. |
| FG006 | Meloxicam, Then Naproxen, Then Celecoxib, Then A, Then B | 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. |
| FG007 | Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A | 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. |
| FG008 | Naproxen, Then Celecoxib, Then Meloxicam, Then A, Then B | 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. |
| FG009 | Naproxen, Then Celecoxib, Then Meloxicam, Then B, Then A | 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. |
| FG010 | Naproxen, Then Meloxicam, Then Celecoxib, Then A, Then B | 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. |
| FG011 | Naproxen, Then Meloxicam, Then Celecoxib, Then B, Then A | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
29 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib | Celecoxib 200 mg capsules twice daily (BID) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | CTCAE version 5.0 | Systematic Assessment |
Terminated due to lack of recruitment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark C. Hwang, MD | The University of Texas Health Science Center at Houston | (713) 500-6597 | Mark.C.Hwang@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2021 | Aug 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D013166 | Spondylitis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D009288 | Naproxen |
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Naproxen | Drug | Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules |
|
| Meloxicam | Drug | Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules |
|
| 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." | 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." | 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." | 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." | 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." | 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." | Baseline, 4 weeks |
| years |
|
| Sex: Female, Male | Sex data were not collected from any participant. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Naproxen | Naproxen 500 mg tablets twice daily (BID) |
|
|
| Secondary | 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. | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | 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." | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | 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." | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | 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." | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | 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." | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | 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." | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | 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." | Posted | Median | 95% Confidence Interval | score on a scale | Baseline, 4 weeks |
|
|
|
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Meloxicam | Meloxicam 7.5 mg tablets twice daily (BID) | 0 | 30 | 1 | 30 | 4 | 30 |
| EG002 | Naproxen | Naproxen 500 mg tablets twice daily (BID) | 0 | 30 | 0 | 30 | 5 | 30 |
| Diarrhea | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE version 5.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009140 |
| Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013843 | Thiazines |
| D013844 | Thiazoles |