CLassification of Axial SpondyloarthritiS Inception Cohort
- Conditions
- Spondyloarthritis
- Registration Number
- NCT03993847
- Lead Sponsor
- Spondyloarthritis Research and Treatment Network
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
- Undiagnosed back and/or buttock pain
- Back, buttock or hip discomfort in the week before the study visit
- Discomfort in the back, buttocks, or hips that has lasted at least three months.
- First symptoms of pain when patient was ≤ 45 years of age:
- Patients with a known rheumatologist confirmed diagnosis of spondyloarthritis at the time of referral to the study-affiliated investigator.
- Patients with a history of spinal trauma in the past 3 months.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation. 6 weeks Physician will answer Yes or No.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Sacramento VA Medical Center
🇺🇸Mather, California, United States
UCSF Medical Center - Rheumatology Clinic
🇺🇸San Francisco, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
James J. Peters VAMC
🇺🇸Bronx, New York, United States
Columbia University
🇺🇸New York, New York, United States
Dallas VA Medical Center VANTHCS
🇺🇸Dallas, Texas, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Artus Health Center
🇨🇦Vancouver, British Columbia, Canada
CLIDITER
🇲🇽Mexico City, Cdmx, Mexico
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Centro de Estudios de Investigacion Basica y Clinica, SC
🇲🇽Guadalajara, Jalisco, Mexico
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University Health Network
🇨🇦Toronto, Ontario, Canada
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Seattle Rheumatology Associates
🇺🇸Seattle, Washington, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States