Ankylosing Spondylitis, Axial Spondyloarthritis
Conditions
Keywords
ankylosing spondylitis, spondyloarthritis
Brief summary
This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.
Detailed description
Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg every 12 hours (Q12H); 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. The treatment length will be 6 weeks. Primary outcome is the change of pain score from baseline to week 4 and to week 6.
Interventions
DRUGIndomethacin
Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
DRUGDiclofenac
Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
DRUGMeloxicam
meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
DRUGCelecoxib
Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of ankylosing spondylitis (AS) by treating rheumatologists, or a diagnosis of axial spondyloarthritis (axSpA) with a pelvis MRI with significant bone marrow edema on STIR sequences; * Minimum of 18 years old; * Are taking NSAIDs on a regular basis for AS or axSpA (defined as more than 20 days in the past month) and willing to withhold medication for one week; or having active symptoms that require initiation of NSAIDs; * Concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the past three months; * Have active disease after initial washout period, defined by BASDAI \>=4/10, or back pain numerical rating scale (NRS)\>=4/10
Exclusion criteria
* Patients who have concurrent rheumatic diseases other than AS or axSpA; * Patients who have oral corticosteroid in the past two weeks; patients who have acute peripheral arthritis; * Patients with a fibromyalgia score \>= 13; * Patient with extensive cardiac history, history of gastrointestinal bleeding that required blood transfusion, chronic kidney diseases, abnormal liver function tests; or female patients who are pregnant. Use of low-dose of aspirin (\<100mg daily) is allowed in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain Score | Baseline, Week 4, and Week 6 | Change of pain score by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline, Week 4, and Week 6 | Change of BASDAI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\] |
| Change of Bath Ankylosing Spondylitis Function Index (BASFI) | Baseline, Week 4, and Week 6 | Change of BASFI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\] |
| Change of ASAS Endorsed Disease Activity Score (ASDAS) | Baseline, Week 4, and Week 6 | Change of ASDAS by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\] |
| Patient Global Assessment of Response to Therapy (PGART) | Week 6 | Likert Scale on whether effective or not. |
Countries
United States
Participant flow
Pre-assignment details
This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Participants by arm
| Arm | Count |
|---|---|
| NSAIDs Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks; OR Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | NSAIDs | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| ASAS Endorsed Disease Activity Score (ASDAS) | 3.34 units on a scale | — |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 4.9 units on a scale | — |
| Bath Ankylosing Spondylitis Function Index (BASFI) | 3.7 units on a scale | — |
| Pain | 6 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 1 / 3 | 1 / 2 | 2 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change of Pain Score
Change of pain score by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Time frame: Baseline, Week 4, and Week 6
Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NSAIDs x 4 Weeks | Change of Pain Score | -2 units on a scale |
| NSAIDs x 6 Weeks | Change of Pain Score | -2 units on a scale |
Secondary
Change of ASAS Endorsed Disease Activity Score (ASDAS)
Change of ASDAS by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Time frame: Baseline, Week 4, and Week 6
Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NSAIDs x 4 Weeks | Change of ASAS Endorsed Disease Activity Score (ASDAS) | -0.37 units on a scale |
| NSAIDs x 6 Weeks | Change of ASAS Endorsed Disease Activity Score (ASDAS) | -0.84 units on a scale |
Secondary
Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Change of BASDAI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Time frame: Baseline, Week 4, and Week 6
Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NSAIDs x 4 Weeks | Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | -1.7 units on a scale |
| NSAIDs x 6 Weeks | Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | -2.09 units on a scale |
Secondary
Change of Bath Ankylosing Spondylitis Function Index (BASFI)
Change of BASFI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Time frame: Baseline, Week 4, and Week 6
Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NSAIDs x 4 Weeks | Change of Bath Ankylosing Spondylitis Function Index (BASFI) | -0.8 units on a scale |
| NSAIDs x 6 Weeks | Change of Bath Ankylosing Spondylitis Function Index (BASFI) | -1.2 units on a scale |
Secondary
Patient Global Assessment of Response to Therapy (PGART)
Likert Scale on whether effective or not.
Time frame: Week 6
Population: The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NSAIDs x 4 Weeks | Patient Global Assessment of Response to Therapy (PGART) | Strongly Disagree | 0 Participants |
| NSAIDs x 4 Weeks | Patient Global Assessment of Response to Therapy (PGART) | Somewhat Disagree | 0 Participants |
| NSAIDs x 4 Weeks | Patient Global Assessment of Response to Therapy (PGART) | Neutral | 2 Participants |
| NSAIDs x 4 Weeks | Patient Global Assessment of Response to Therapy (PGART) | Somewhat Agree | 3 Participants |
| NSAIDs x 4 Weeks | Patient Global Assessment of Response to Therapy (PGART) | Strongly Agree | 4 Participants |