Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03993847
Other study ID # CLASSIC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 4, 2019
Est. completion date August 22, 2022

Study information

Verified date December 2022
Source Spondyloarthritis Research and Treatment Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 501
Est. completion date August 22, 2022
Est. primary completion date August 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada The Ottawa Hospital Ottawa Ontario
Canada University Health Network Toronto Ontario
Canada Artus Health Center Vancouver British Columbia
Mexico Centro de Estudios de Investigacion Basica y Clinica, SC Guadalajara Jalisco
Mexico CLIDITER Mexico City Cdmx
United States University of Colorado Aurora Colorado
United States Boston University School of Medicine Boston Massachusetts
United States Brigham & Women's Hospital Boston Massachusetts
United States James J. Peters VAMC Bronx New York
United States Cleveland Clinic Cleveland Ohio
United States Dallas VA Medical Center VANTHCS Dallas Texas
United States University of Texas Health Science Center at Houston Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States VA Long Beach Healthcare System Long Beach California
United States Sacramento VA Medical Center Mather California
United States Yale University School of Medicine New Haven Connecticut
United States Columbia University New York New York
United States Oregon Health & Science University Portland Oregon
United States UCSF Medical Center - Rheumatology Clinic San Francisco California
United States Seattle Rheumatology Associates Seattle Washington

Sponsors (8)

Lead Sponsor Collaborator
Spondyloarthritis Research and Treatment Network AbbVie, Amgen, Eli Lilly and Company, Janssen Scientific Affairs, LLC, Novartis Pharmaceuticals, Pfizer, UCB Pharma

Countries where clinical trial is conducted

United States,  Canada,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation. Physician will answer Yes or No. 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT03564743 - Description of Spondylarthritis and Validation of ASAS Criteria in West Indian Patients Seen in Consultation of Rheumatology.
Completed NCT01219257 - Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy
Recruiting NCT05433168 - Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis N/A
Terminated NCT03232580 - 99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis Phase 2
Recruiting NCT05039216 - Biobank for Inflammatory Chronic Diseases and Osteoporosis
Completed NCT04483648 - Cervical Stabilization Exercises in Patients With Spondyloarthritis N/A
Recruiting NCT04602091 - Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)
Not yet recruiting NCT04077957 - Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs Phase 4
Recruiting NCT05290363 - The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis N/A
Not yet recruiting NCT05006690 - Telerehabilitation, Face-to-Face and Home-Based Spinal Stabilization Exercise Training in Patients With Spondyloarthritis N/A
Completed NCT02998398 - Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital
Completed NCT02148640 - The NOR-SWITCH Study Phase 4
Completed NCT01174186 - Intestinal Inflammation in Ankylosing Spondylitis and the Effects of Adalimumab on Mucosal Healing Phase 4
Recruiting NCT04499001 - Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs
Completed NCT03253796 - Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038) Phase 4
Active, not recruiting NCT04169373 - A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis Phase 3
Recruiting NCT04292067 - Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Completed NCT04946539 - Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis
Recruiting NCT03983473 - Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. N/A
Terminated NCT03345355 - MRI of Sacroiliac Joints: Evaluation of Accuracy of Dixon Sequences in the Diagnosis of Axial Spondyloarthritis