CLassification of Axial SpondyloarthritiS Inception Cohort
NCT ID: NCT03993847
Last Updated: 2022-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
501 participants
OBSERVATIONAL
2019-12-04
2022-08-22
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective Cohort of Undiagnosed Back Pain
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.
This is a classification study; no intervention will be administered
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Amgen
INDUSTRY
Janssen Scientific Affairs, LLC
INDUSTRY
Eli Lilly and Company
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Pfizer
INDUSTRY
UCB Pharma
INDUSTRY
Spondyloarthritis Research and Treatment Network
NETWORK
Responsible Party
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Principal Investigators
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Walter P Maksymoywch, MD
Role: PRINCIPAL_INVESTIGATOR
Spondyloarthritis Research and Treatment Network
Locations
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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
University of Colorado
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Columbia University
New York, New York, United States
James J. Peters VAMC
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Dallas VA Medical Center VANTHCS
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Artus Health Center
Vancouver, British Columbia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Centro de Estudios de Investigacion Basica y Clinica, SC
Guadalajara, Jalisco, Mexico
CLIDITER
Mexico City, Mexico City, Mexico
Countries
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References
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Helliwell PS. 50 years of spondyloarthritis: a look back and a look ahead. Curr Opin Rheumatol. 2024 Jul 1;36(4):261-266. doi: 10.1097/BOR.0000000000001019. Epub 2024 Apr 24.
Other Identifiers
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CLASSIC
Identifier Type: -
Identifier Source: org_study_id
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