Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03473665
• Date of registration: 13/03/2018
• Prospective Registration: No
• Primary sponsor: Columbia University
• Public title: Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis
• Scientific title: Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study
• Date of first enrolment: March 1, 2018
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03473665
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Runsheng Wang, MD, MHS
• Affiliation: Columbia University

Key inclusion & exclusion criteria

Inclusion Criteria:

- A clinical diagnosis of ankylosing spondylitis (AS) by treating rheumatologists, or a
diagnosis of axial spondyloarthritis (axSpA) with a pelvis MRI with significant bone
marrow edema on STIR sequences;

- Minimum of 18 years old;

- Are taking NSAIDs on a regular basis for AS or axSpA (defined as more than 20 days in
the past month) and willing to withhold medication for one week; or having active
symptoms that require initiation of NSAIDs;

- Concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the past
three months;

- Have active disease after initial washout period, defined by BASDAI >=4/10, or back
pain numerical rating scale (NRS)>=4/10

Exclusion Criteria:

- Patients who have concurrent rheumatic diseases other than AS or axSpA;

- Patients who have oral corticosteroid in the past two weeks; patients who have acute
peripheral arthritis;

- Patients with a fibromyalgia score >= 13;

- Patient with extensive cardiac history, history of gastrointestinal bleeding that
required blood transfusion, chronic kidney diseases, abnormal liver function tests; or
female patients who are pregnant.

Use of low-dose of aspirin (<100mg daily) is allowed in the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Axial Spondyloarthritis

Intervention(s)

Drug: Diclofenac

Drug: Celecoxib

Drug: Indomethacin

Drug: Meloxicam

Primary Outcome(s)

Change of Pain Score [Time Frame: Baseline, Week 4, and Week 6]

Secondary Outcome(s)

Change of ASAS Endorsed Disease Activity Score (ASDAS) [Time Frame: Baseline, Week 4, and Week 6]

Patient Global Assessment of Response to Therapy (PGART) [Time Frame: Week 6]

Change of Bath Ankylosing Spondylitis Function Index (BASFI) [Time Frame: Baseline, Week 4, and Week 6]

Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: Baseline, Week 4, and Week 6]

Secondary ID(s)

AAAR3505

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03473665