Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

NCT ID: NCT03473665

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-08-02

Brief 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.

Detailed 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.

Conditions

Ankylosing Spondylitis; Axial Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Indomethacin

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

Group Type: ACTIVE_COMPARATOR

Indomethacin

Intervention Type: DRUG

Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Diclofenac

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

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Meloxicam

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

Group Type: ACTIVE_COMPARATOR

Meloxicam

Intervention Type: DRUG

meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Celecoxib

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

Group Type: ACTIVE_COMPARATOR

Celecoxib

Intervention Type: DRUG

Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Interventions

Indomethacin

Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Intervention Type: DRUG

Diclofenac

Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Intervention Type: DRUG

Meloxicam

meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Intervention Type: DRUG

Celecoxib

Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks

Intervention Type: DRUG

Other Intervention Names

INDO; Indomethacin ER; DIC; Diclofenac DR; Voltarin; MLX; CEL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Runsheng Wang, MD, MHS

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Runsheng Wang, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR3505

Identifier Type: -

Identifier Source: org_study_id