CLassification of Axial SpondyloarthritiS Inception Cohort

NCT03993847 | Completed

• 1 other identifier: CLASSIC
• Study Type: observational
• Target: 501
• Locations: 3 countries
• Sites: 20

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.

Conditions

Spondyloarthritis

Keywords

Spondyloarthritis; SPARTAN; ASAS; SpA; Undiagnosed Back Pain

Outcome Measures

Primary Outcomes (1)

• Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation.

  Physician will answer Yes or No.

  6 weeks

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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:

You may not qualify if:

• 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)

Sponsors & Collaborators

• Spondyloarthritis Research and Treatment Network: lead
• AbbVie: collaborator
• Amgen: collaborator
• Janssen Scientific Affairs, LLC: collaborator
• Eli Lilly and Company: collaborator
• Novartis Pharmaceuticals: collaborator
• Pfizer: collaborator
• UCB Pharma: collaborator

Study Sites (20)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Sacramento VA Medical Center

Mather, California, 95655, United States

Location

UCSF Medical Center - Rheumatology Clinic

San Francisco, California, 94143, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06067, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Columbia University

New York, New York, 10032, United States

Location

James J. Peters VAMC

The Bronx, New York, 10468, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Dallas VA Medical Center VANTHCS

Dallas, Texas, 75216, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98122, United States

Location

Artus Health Center

Vancouver, British Columbia, V5Z 1L9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

University Health Network

Toronto, Ontario, M5T2S8, Canada

Location

Centro de Estudios de Investigacion Basica y Clinica, SC

Guadalajara, Jalisco, 44690, Mexico

Location

CLIDITER

Mexico City, Mexico City, 06700, Mexico

Location

Related Publications (1)

• 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.

  PMID: 38656252 DERIVED

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Walter P Maksymoywch, MD

  Spondyloarthritis Research and Treatment Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 21, 2019
• Study Start: December 4, 2019
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

CA (3); US (15); ME (2)