Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis

NCT03473665 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: AAAR3505
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis; Axial Spondyloarthritis

Keywords

ankylosing spondylitis; spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline, Week 4, and Week 6

• Change of Bath Ankylosing Spondylitis Function Index (BASFI)

  Baseline, Week 4, and Week 6

• Change of ASAS Endorsed Disease Activity Score (ASDAS)

  Baseline, Week 4, and Week 6

• Patient Global Assessment of Response to Therapy (PGART)

  Week 6

Study Arms (4)

Indomethacin

ACTIVE COMPARATOR

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

Drug: Indomethacin

Diclofenac

ACTIVE COMPARATOR

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

Drug: Diclofenac

Meloxicam

ACTIVE COMPARATOR

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

Drug: Meloxicam

Celecoxib

ACTIVE COMPARATOR

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

Drug: Celecoxib

Interventions

Indomethacin DRUG

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

Also known as: INDO, Indomethacin ER

Indomethacin

Diclofenac DRUG

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

Also known as: DIC, Diclofenac DR, Voltarin

Diclofenac

Meloxicam DRUG

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

Also known as: MLX

Meloxicam

Celecoxib DRUG

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

Also known as: CEL

Celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis; Spondylarthritis

Interventions

Indomethacin; Diclofenac; Dacarbazine; Meloxicam; Celecoxib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Thiazines; Sulfur Compounds; Thiazoles; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Pyrazoles

Results Point of Contact

• Title: Runsheng Wang
• Organization: Columbia University

rw2646@cumc.columbia.edu

212-305-4308

Study Officials

• Runsheng Wang, MD, MHS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 22, 2018
• Study Start: March 1, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: September 22, 2020
• Results First Posted: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)