NCT04115098

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Celecoxib	Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
DRUG	Naproxen	Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules
DRUG	Meloxicam	Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Timeline

• Start date: 2020-06-25
• Primary completion: 2023-08-11
• Completion: 2023-08-11
• First posted: 2019-10-03
• Last updated: 2025-08-13
• Results posted: 2024-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study