CLassification of Axial SpondyloarthritiS Inception Cohort (CLASSIC)

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.

Study Overview

• Status: Completed
• Conditions: Spondyloarthritis

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.

• Study Type: Observational
• Enrollment (Actual): 501

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L9
      • Artus Health Center
  • Ontario
    • Ottawa, Ontario, Canada, K1H 7W9
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5T2S8
      • University Health Network
• Mexico
  • Cdmx
    • Mexico City, Cdmx, Mexico, 06700
      • CLIDITER
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44690
      • Centro de Estudios de Investigacion Basica y Clinica, Sc
• United States
  • California
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System
    • Mather, California, United States, 95655
      • Sacramento VA Medical Center
    • San Francisco, California, United States, 94143
      • UCSF Medical Center - Rheumatology Clinic
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06067
      • Yale University School Of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Medicine
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New York
    • Bronx, New York, United States, 10468
      • James J. Peters VAMC
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center VANTHCS
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
  • Washington
    • Seattle, Washington, United States, 98122
      • Seattle Rheumatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Undiagnosed back and/or buttock pain with onset ≤45 years and duration ≥ 3 months

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation.	Physician will answer Yes or No.	6 weeks

Collaborators and Investigators

• Sponsor: Spondyloarthritis Research and Treatment Network
• Collaborators: Eli Lilly and Company; UCB Pharma; Pfizer; AbbVie; Janssen Scientific Affairs, LLC; Novartis Pharmaceuticals; Amgen
• Investigators: Principal Investigator: Walter P Maksymoywch, MD, Spondyloarthritis Research and Treatment Network

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Spondyloarthritis; SpA; SPARTAN; ASAS; Undiagnosed Back Pain
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: CLASSIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No