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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: National Center for Advancing Translational Science (NCATS)
• Treatments: Anti-Inflammatory Agents

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