Axial Spondyloarthritis
Conditions
Keywords
spondylitis
Brief 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 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
Interventions
DRUGCelecoxib
Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
DRUGNaproxen
Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
DRUGMeloxicam
Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score | Baseline, 4 weeks | 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. |
| Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline, 4 weeks | 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. |
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline, 4 weeks | 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. |
| Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment | Baseline, 4 weeks | 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. |
| Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain) | Baseline, 4 weeks | 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. |
| Change in Visual Analog Scale-Global (VAS-Global) | Baseline, 4 weeks | 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. |
| Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) | Baseline, 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 40.40 years STANDARD_DEVIATION 13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 4 / 30 | 5 / 30 |
| serious Total, serious adverse events | 0 / 30 | 1 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 0.61 score on a scale |
| Meloxicam | Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 0.54 score on a scale |
| Naproxen | Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS) | 0.58 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) | 0.55 score on a scale |
| Meloxicam | Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) | 0.53 score on a scale |
| Naproxen | Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) | 0.37 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 1.07 score on a scale |
| Meloxicam | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 1.19 score on a scale |
| Naproxen | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 1.17 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) | 0.15 score on a scale |
| Meloxicam | Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) | 0.03 score on a scale |
| Naproxen | Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) | 0.11 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score | -0.10 score on a scale |
| Meloxicam | Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score | -0.11 score on a scale |
| Naproxen | Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score | -0.11 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment | -0.07 score on a scale |
| Meloxicam | Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment | -0.04 score on a scale |
| Naproxen | Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment | -0.05 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain) | 11.28 score on a scale |
| Meloxicam | Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain) | 11.26 score on a scale |
| Naproxen | Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain) | 11.32 score on a scale |
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Celecoxib | Change in Visual Analog Scale-Global (VAS-Global) | 14.29 score on a scale |
| Meloxicam | Change in Visual Analog Scale-Global (VAS-Global) | 14.33 score on a scale |
| Naproxen | Change in Visual Analog Scale-Global (VAS-Global) | 14.39 score on a scale |