Clinical trial NCT04115098: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Axial Spondyloarthritis
Keywords: spondylitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-10-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in Health Related Quality of Life as Assessed by the Standard Gamble Utility Assessment
timeFrame: Baseline, 4 weeks
measure: Change in Patient-Information Measurement Information System (PROMIS-29)
timeFrame: Baseline, 4 weeks
measure: Change in Ability to Perform Tasks as Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, 4 weeks
measure: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, 4 weeks
measure: Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline, 4 weeks
measure: Change in Pain as Assessed by the Visual Analog Scale-Pain (VAS-Pain)
timeFrame: Baseline, 4 weeks
measure: Change in Visual Analog Scale-Global (VAS-Global)
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mark C Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: