Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
Primary Purpose
Axial Spondyloarthritis
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drug order 1
Drug order 2
Drug order 3
Drug order 4
Drug order 5
Drug order 6
Sponsored by
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring spondylitis
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Drug order 1
Drug order 2
Drug order 3
Drug order 4
Drug order 5
Drug order 6
Arm Description
Outcomes
Primary Outcome Measures
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Secondary Outcome Measures
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Health related quality of life as assessed by the Standard Gamble Utility assessment
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Patient-Information Measurement Information System (PROMIS-29)
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
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)
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)
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)
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)
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)
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)
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)
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)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Visual Analog Scale-Global VAS-Global
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Full Information
NCT ID
NCT04115098
First Posted
October 2, 2019
Last Updated
May 22, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT04115098
Brief Title
Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
Official Title
Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
August 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug order 1
Arm Type
Experimental
Arm Title
Drug order 2
Arm Type
Experimental
Arm Title
Drug order 3
Arm Type
Experimental
Arm Title
Drug order 4
Arm Type
Experimental
Arm Title
Drug order 5
Arm Type
Experimental
Arm Title
Drug order 6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Drug order 1
Intervention Description
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. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Intervention Type
Drug
Intervention Name(s)
Drug order 2
Intervention Description
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. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Intervention Type
Drug
Intervention Name(s)
Drug order 3
Intervention Description
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. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Intervention Type
Drug
Intervention Name(s)
Drug order 4
Intervention Description
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. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Intervention Type
Drug
Intervention Name(s)
Drug order 5
Intervention Description
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. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Intervention Type
Drug
Intervention Name(s)
Drug order 6
Intervention Description
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. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Primary Outcome Measure Information:
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Baseline
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Visit 1,week 5
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Visit 2,week 9
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Visit 3,week 13
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Visit 4,week 17
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Visit 5,week 21
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Visit 6,week 25
Title
Extent of disease activity as measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
The ASDAS score ranges from 0-10 with a higher score meaning worse disease activity.
Time Frame
Visit 7,week 29
Secondary Outcome Measure Information:
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
baseline,week 1
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
Visit 1,week 5
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
Visit 2,week 9
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
Visit 3,week 13
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
Visit 4,week 17
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
Visit 5,week 21
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
Visit 6,week 25
Title
Health related quality of life as assessed by the Standard Gamble Utility assessment
Description
The Standard Gamble Utility assessment is scored between 0-1,0 being worst outcome and 1 being best outcome
Time Frame
Visit 7,week 29
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Baseline,Week 1
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Visit 1,week 5
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Visit 2,week 9
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Visit 3,week 13
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Visit 4,week 17
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Visit 5,week 21
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Visit 6,week 25
Title
Patient-Information Measurement Information System (PROMIS-29)
Description
The PROMIS-29 has 29 questions which are each scored form 1-5,1 being unable to do and 5 being able to do without difficulty
Time Frame
Visit 7,week 29
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Baseline,Week1
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Visit 1,week 5
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Visit 2,week 9
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Visit 3,week 13
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Visit 4,week 17
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Visit 5,week 21
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Visit 6,week 25
Title
Change in ability to perform tasks as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
BASFI score ranges form 0-10, 0 being easy and 10 being impossible
Time Frame
Visit 7,week 29
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Baseline,Week1
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Visit 1,week 5
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Visit 2,week 9
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Visit 3,week 13
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Visit 4,week 17
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Visit 5,week 21
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Visit 6,week 25
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Description
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem)
Time Frame
Visit 7,week 29
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
Baseline,Week1
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
Visit 1,week 5
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
Visit 2, week 9
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
Visit 3,week 13
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
Visit 4,week 17
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
Visit 5,week 21
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
visit 6,week 25
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
BASMI score of 0-10 is calculated.The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
Time Frame
visit 7,week 29
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Baseline,Week 1
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Visit 1,Week 5
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Visit 2,Week 9
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Visit 3,Week13
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Visit 4,Week17
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Visit 5,Week 21
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Visit 6,Week 25
Title
Change in pain as assessed by the Visual Analog Scale-Pain (VAS-Pain)
Description
The VAS Pain is scored form 0-10 0 being no pain and 10 being unbearable pain
Time Frame
Visit 7,Week 29
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Baseline,week1
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Visit1,week5
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Visit2,week9
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Visit 3,week 13
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Visit 4,week 17
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Visit 5,week 21
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Visit 6,week 25
Title
Visual Analog Scale-Global VAS-Global
Description
The VAS-Global is scored form 0-10 0 being not active and 10 being very active
Time Frame
Visit 7,week 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C Hwang, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials
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