Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials

Axial Spondyloarthritis Clinical Trial

Official title:

Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115098
• Other study ID #: HSC-MS-19-0677
• Secondary ID: KL2TR003168
• Status: Completed
• Phase: Phase 2
• Start date: June 25, 2020
• Est. completion date: November 27, 2023

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 27, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• Drug order 1
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.
• Drug order 2
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.
• Drug order 3
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.
• Drug order 4
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.
• Drug order 5
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.
• Drug order 6
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Visit 1,week 5
Primary	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.	Visit 2,week 9
Primary	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.	Visit 3,week 13
Primary	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.	Visit 4,week 17
Primary	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.	Visit 5,week 21
Primary	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.	Visit 6,week 25
Primary	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.	Visit 7,week 29
Secondary	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	baseline,week 1
Secondary	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	Visit 1,week 5
Secondary	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	Visit 2,week 9
Secondary	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	Visit 3,week 13
Secondary	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	Visit 4,week 17
Secondary	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	Visit 5,week 21
Secondary	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	Visit 6,week 25
Secondary	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	Visit 7,week 29
Secondary	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	Baseline,Week 1
Secondary	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	Visit 1,week 5
Secondary	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	Visit 2,week 9
Secondary	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	Visit 3,week 13
Secondary	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	Visit 4,week 17
Secondary	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	Visit 5,week 21
Secondary	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	Visit 6,week 25
Secondary	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	Visit 7,week 29
Secondary	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	Baseline,Week1
Secondary	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	Visit 1,week 5
Secondary	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	Visit 2,week 9
Secondary	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	Visit 3,week 13
Secondary	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	Visit 4,week 17
Secondary	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	Visit 5,week 21
Secondary	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	Visit 6,week 25
Secondary	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	Visit 7,week 29
Secondary	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)	Baseline,Week1
Secondary	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)	Visit 1,week 5
Secondary	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)	Visit 2,week 9
Secondary	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)	Visit 3,week 13
Secondary	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)	Visit 4,week 17
Secondary	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)	Visit 5,week 21
Secondary	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)	Visit 6,week 25
Secondary	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)	Visit 7,week 29
Secondary	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	Baseline,Week1
Secondary	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	Visit 1,week 5
Secondary	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	Visit 2, week 9
Secondary	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	Visit 3,week 13
Secondary	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	Visit 4,week 17
Secondary	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	Visit 5,week 21
Secondary	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	visit 6,week 25
Secondary	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	visit 7,week 29
Secondary	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	Baseline,Week 1
Secondary	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	Visit 1,Week 5
Secondary	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	Visit 2,Week 9
Secondary	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	Visit 3,Week13
Secondary	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	Visit 4,Week17
Secondary	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	Visit 5,Week 21
Secondary	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	Visit 6,Week 25
Secondary	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	Visit 7,Week 29
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Baseline,week1
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Visit1,week5
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Visit2,week9
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Visit 3,week 13
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Visit 4,week 17
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Visit 5,week 21
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Visit 6,week 25
Secondary	Visual Analog Scale-Global VAS-Global	The VAS-Global is scored form 0-10 0 being not active and 10 being very active	Visit 7,week 29