Trial Outcomes & Findings for Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials (NCT NCT04115098)
NCT ID: NCT04115098
Last Updated: 2025-08-13
Results Overview
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."
TERMINATED
PHASE2
42 participants
Baseline, 4 weeks
2025-08-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
3
|
4
|
5
|
2
|
0
|
7
|
4
|
3
|
4
|
3
|
|
Overall Study
4-week Treatment Session 1
|
5
|
2
|
3
|
4
|
5
|
2
|
0
|
7
|
4
|
3
|
4
|
3
|
|
Overall Study
4-week Treatment Session 2
|
4
|
2
|
3
|
4
|
4
|
2
|
0
|
6
|
3
|
3
|
4
|
3
|
|
Overall Study
4-week Treatment Session 3
|
3
|
2
|
3
|
4
|
4
|
1
|
0
|
6
|
3
|
2
|
4
|
2
|
|
Overall Study
4-week Treatment Session 4
|
3
|
2
|
3
|
4
|
3
|
1
|
0
|
6
|
2
|
2
|
4
|
2
|
|
Overall Study
4-week Treatment Session 5
|
2
|
2
|
3
|
4
|
3
|
1
|
0
|
6
|
2
|
1
|
4
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
4
|
3
|
1
|
0
|
6
|
2
|
1
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
2
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=30 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.
|
|---|---|
|
Age, Continuous
|
40.40 years
STANDARD_DEVIATION 13 • n=30 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe 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."
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
|
0.61 score on a scale
Interval 0.35 to 0.87
|
0.54 score on a scale
Interval 0.28 to 0.81
|
0.58 score on a scale
Interval 0.32 to 0.84
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThe 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.
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment
|
-0.07 score on a scale
Interval -0.18 to 0.04
|
-0.04 score on a scale
Interval -0.16 to 0.07
|
-0.05 score on a scale
Interval -0.16 to 0.06
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThe 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."
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Health-Related Quality of Life as Assessed by the PROMIS-Preference (PROPr) Score
|
-0.10 score on a scale
Interval -0.14 to -0.05
|
-0.11 score on a scale
Interval -0.16 to -0.06
|
-0.11 score on a scale
Interval -0.16 to -0.06
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksBASFI 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."
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
|
0.55 score on a scale
Interval 0.11 to 1.0
|
0.53 score on a scale
Interval 0.08 to 0.99
|
0.37 score on a scale
Interval -0.07 to 0.83
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThe 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."
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
1.07 score on a scale
Interval 0.49 to 1.63
|
1.19 score on a scale
Interval 0.62 to 1.76
|
1.17 score on a scale
Interval 0.59 to 1.74
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksBASMI 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."
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)
|
0.15 score on a scale
Interval -0.07 to 0.37
|
0.03 score on a scale
Interval -0.19 to 0.26
|
0.11 score on a scale
Interval -0.11 to 0.33
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThe 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."
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain)
|
11.28 score on a scale
Interval 5.32 to 17.22
|
11.26 score on a scale
Interval 5.26 to 17.18
|
11.32 score on a scale
Interval 5.42 to 17.12
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThe 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."
Outcome measures
| Measure |
Celecoxib
n=30 Participants
Celecoxib 200 mg capsules BID
|
Meloxicam
n=30 Participants
Meloxicam 7.5 mg tablets
|
Naproxen
n=30 Participants
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Change in Visual Analog Scale-Global (VAS-Global)
|
14.29 score on a scale
Interval 7.94 to 20.35
|
14.33 score on a scale
Interval 7.97 to 20.38
|
14.39 score on a scale
Interval 8.13 to 20.36
|
Adverse Events
Celecoxib
Meloxicam
Naproxen
Serious adverse events
| Measure |
Celecoxib
n=30 participants at risk
Celecoxib 200 mg capsules twice daily (BID)
|
Meloxicam
n=30 participants at risk
Meloxicam 7.5 mg tablets twice daily (BID)
|
Naproxen
n=30 participants at risk
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
Other adverse events
| Measure |
Celecoxib
n=30 participants at risk
Celecoxib 200 mg capsules twice daily (BID)
|
Meloxicam
n=30 participants at risk
Meloxicam 7.5 mg tablets twice daily (BID)
|
Naproxen
n=30 participants at risk
Naproxen 500 mg tablets twice daily (BID)
|
|---|---|---|---|
|
Eye disorders
Uveitis
|
0.00%
0/30 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
6.7%
2/30 • Number of events 2 • 29 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • Number of events 1 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/30 • 29 weeks
|
0.00%
0/30 • 29 weeks
|
3.3%
1/30 • Number of events 11 • 29 weeks
|
Additional Information
Mark C. Hwang, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place