TerminatedPhase 2

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

Stopped: lack of recruitment

United States42 participantsStarted 2020-06-25

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Disease Activity as Measured by the Ankylosing Spondylitis Disease Activity Score (ASDAS)

Timeframe: Baseline, 4 weeks

Trial details

NCT IDNCT04115098

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-11

Results submitted2024-08-08