Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

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

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.

Study Overview

• Status: Terminated
• Conditions: Ankylosing Spondylitis; Axial Spondyloarthritis
• Intervention / Treatment: Drug: Indomethacin; Drug: Diclofenac; Drug: Meloxicam; Drug: Celecoxib

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Indomethacin; Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks	Drug: Indomethacin; Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks; Other Names: INDO; Indomethacin ER
Active Comparator: Diclofenac; Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks	Drug: Diclofenac; Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks; Other Names: DIC; Diclofenac DR; Voltarin
Active Comparator: Meloxicam; Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks	Drug: Meloxicam; meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks; Other Names: MLX
Active Comparator: Celecoxib; Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks	Drug: Celecoxib; Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks; Other Names: CEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Patient Global Assessment of Response to Therapy (PGART)	Likert Scale on whether effective or not.	Week 6

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Runsheng Wang, MD, MHS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: ankylosing spondylitis; spondyloarthritis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Cyclooxygenase 2 Inhibitors; Gout Suppressants; Tocolytic Agents; Celecoxib; Diclofenac; Indomethacin; Meloxicam
• Other Study ID Numbers: AAAR3505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No