Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Ankylosing Spondylitis Clinical Trial

Official title:

Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03473665
• Other study ID #: AAAR3505
• Status: Terminated
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: September 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.

Description:

Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg every 12 hours (Q12H); 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. The treatment length will be 6 weeks. Primary outcome is the change of pain score from baseline to week 4 and to week 6.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Indomethacin
Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
• Diclofenac
Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
• Meloxicam
meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
• Celecoxib
Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain Score	Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]	Baseline, Week 4, and Week 6
Secondary	Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Change of BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]	Baseline, Week 4, and Week 6
Secondary	Change of Bath Ankylosing Spondylitis Function Index (BASFI)	Change of BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]	Baseline, Week 4, and Week 6
Secondary	Change of ASAS Endorsed Disease Activity Score (ASDAS)	Change of ASDAS by numerical rating score from baseline [scale range: 0 (better) -10 (worse)]	Baseline, Week 4, and Week 6
Secondary	Patient Global Assessment of Response to Therapy (PGART)	Likert Scale on whether effective or not.	Week 6