Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
Phase 2
Completed
- Conditions
- Axial Spondyloarthritis
- Interventions
- Registration Number
- NCT04115098
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B Celecoxib 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 A, Then B Naproxen 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 A, Then B Meloxicam 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 Celecoxib 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 Naproxen 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 Naproxen 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 Meloxicam 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 B, Then A Naproxen 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 Celecoxib 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 Meloxicam 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 B, Then A Celecoxib 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 B, Then A Meloxicam 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 Celecoxib 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 Naproxen 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 Celecoxib 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 Meloxicam 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 Naproxen 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 Meloxicam 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 Celecoxib 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 Naproxen 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 Meloxicam 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 Celecoxib 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. Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A Meloxicam 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. Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A Naproxen 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 Celecoxib 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 Naproxen 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 Celecoxib 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 Meloxicam 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 Naproxen 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 Meloxicam 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 Celecoxib 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 Naproxen 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 Meloxicam 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 Naproxen 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 Celecoxib 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 Meloxicam 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in Patient-Information Measurement Information System (PROMIS-29) Baseline, 4 weeks The PROMIS-29 has 29 questions which are each scored form 1-5, with 1 being unable to do the item presented and 5 being able to do without difficulty. 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 "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 "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 form 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 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."Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain) Baseline, 4 weeks The VAS Pain total score is 0 - 10, with 0 being no pain and 10 being unbearable pain. 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 form 0-10, with 0 being not active and 10 being very active. The "Measure of Dispersion/Precision" indicated as "95% Confidence Interval" actually refers to a "95% Credible Interval."
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States