Clinical trial NCT03993847: CLassification of Axial SpondyloarthritiS Inception Cohort
Official title: CLassification of Axial SpondyloarthritiS Inception Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthritis
Keywords: Spondyloarthritis
SPARTAN
ASAS
SpA
Undiagnosed Back Pain
Lead sponsor: Spondyloarthritis Research and Treatment Network
Sponsor class: NETWORK
Collaborators: name: AbbVie
name: Amgen
name: Janssen Scientific Affairs, LLC
name: Eli Lilly and Company
name: Novartis Pharmaceuticals
name: Pfizer
name: UCB Pharma
First posted: 2019-06-21
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Undiagnosed back and/or buttock pain with onset ≤45 years and duration ≥ 3 months

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Mather
country: United States
facility: Sacramento VA Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center - Rheumatology Clinic
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Bronx
country: United States
facility: James J. Peters VAMC
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: Dallas VA Medical Center VANTHCS
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Vancouver
country: Canada
facility: Artus Health Center
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Mexico City
country: Mexico
facility: CLIDITER
state: Cdmx
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica, SC
state: Jalisco
Study officials:
affiliation: Spondyloarthritis Research and Treatment Network
name: Walter P Maksymoywch, MD
role: PRINCIPAL_INVESTIGATOR
References: