Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

Columbia University

Status and phase: Terminated; Phase 4

Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis

Treatments: Drug: Diclofenac; Drug: Celecoxib; Drug: Meloxicam; Drug: Indomethacin

Study type: Interventional

Funder types: Other

Identifiers

NCT03473665

AAAR3505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 4 patient groups

Indomethacin

Active Comparator group

Description:

Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks

Treatment:

Drug: Indomethacin

Diclofenac

Active Comparator group

Description:

Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks

Treatment:

Drug: Diclofenac

Meloxicam

Active Comparator group

Description:

Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks

Treatment:

Drug: Meloxicam

Celecoxib

Active Comparator group

Description:

Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks

Treatment:

Drug: Celecoxib