CLassification of Axial SpondyloarthritiS Inception Cohort

Spondyloarthritis Clinical Trial

— CLASSIC  

Official title:

CLassification of Axial SpondyloarthritiS Inception Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993847
• Other study ID #: CLASSIC
• Status: Completed
• Start date: December 4, 2019
• Est. completion date: August 22, 2022

Study information

• Verified date: December 2022
• Source: Spondyloarthritis Research and Treatment Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A joint meeting of the ASAS (Assessment of Spondyloarthritis Internal Society) and SPARTAN (Spondyloarthritis Research and Treatment Network) executive boards recommended that the existing ASAS classification criteria for spondyloarthritis undergo further validation.

SPARTAN is in charge of conducting a a prospective study of a North American cohort of patients presenting with undiagnosed active chronic back pain to rheumatologists in the US and Canada, and one site in Mexico.

ASAS is in charge of conducting a similar study in Europe and other parts of the world.

Description:

The overall study design will follow a similar format to that used to develop the ASAS axial SpA classification criteria. All consecutive patients referred to a rheumatologist with current undiagnosed back pain of ≥3 months duration with onset ≤45 years of age will comprise the prospective cohort. The sample size of 500 from North America (minimum of 300 from the US) and 500 from outside North America is aimed at ensuring that a sufficient number of patients will have axSpA and also permit the option to conduct 5-year follow up to determine predictive validity of the classification criteria. The clinical assessment data, including the history and physical examination, will be recorded by the rheumatologist in the electronic case report form (eCRF). This will be accessed through an online portal.

The rheumatologist will complete 5 global assessments to determine the presence/absence of axSpA. The first will be completed immediately after the first clinical assessment at the end of the patient encounter and will incorporate details of the history and physical exam. This is aimed at ascertaining which clinical features are considered most important in formulating the rheumatologist's opinion regarding the diagnosis of axSpA. The second will be conducted once the C-Reactive Protein (CRP), and HLA-B27 data are made available. The third will be completed after the pelvic radiograph has been reviewed by the rheumatologist. The fourth will be completed after the rheumatologist has reviewed the report of the pelvic MRI scan provided by the local radiologist. The fifth will be completed after central review of the anonymized radiograph and pelvic MRI scan and feedback to both the rheumatologist and radiologist. In ASAS centers outside North America, it may not be possible to have an assessment of each separate step as indicated if the rheumatologist already receives information on lab and imaging results in the referral later. In that circumstance, only global assessments 4 and 5 will be used as external standards. Patients will then be followed according to the discretion of the rheumatologist and appropriate standards of clinical practice. Patient contact information will be obtained and patient consent obtained through the informed consent to allow contact with the patient after 5 years of follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Undiagnosed back and/or buttock pain

2. Back, buttock or hip discomfort in the week before the study visit

3. Discomfort in the back, buttocks, or hips that has lasted at least three months.

4. First symptoms of pain when patient was = 45 years of age:

Exclusion Criteria:

1. Patients with a known rheumatologist confirmed diagnosis of spondyloarthritis at the time of referral to the study-affiliated investigator.

2. Patients with a history of spinal trauma in the past 3 months.

3. Patients unable and/or unwilling to undergo MRI examination (embedded metallic fragments, pacemaker, joint replacement or similar hardware, too large (over 350 pounds unless their MRI can scan larger patients), claustrophobic)

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	Artus Health Center	Vancouver	British Columbia
Mexico	Centro de Estudios de Investigacion Basica y Clinica, SC	Guadalajara	Jalisco
Mexico	CLIDITER	Mexico City	Cdmx
United States	University of Colorado	Aurora	Colorado
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	James J. Peters VAMC	Bronx	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dallas VA Medical Center VANTHCS	Dallas	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Sacramento VA Medical Center	Mather	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	UCSF Medical Center - Rheumatology Clinic	San Francisco	California
United States	Seattle Rheumatology Associates	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Spondyloarthritis Research and Treatment Network	AbbVie, Amgen, Eli Lilly and Company, Janssen Scientific Affairs, LLC, Novartis Pharmaceuticals, Pfizer, UCB Pharma

Countries where clinical trial is conducted

United States,  Canada,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation.	Physician will answer Yes or No.	6 weeks