CLassification of Axial SpondyloarthritiS Inception Cohort

NCT03993847

Last updated date
Study Location
Yale University School of Medicine
New Haven, Connecticut, 06067, United States
Contact
587-400-9524

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Spondyloarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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)

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SpondyloarthritisCLassification of Axial SpondyloarthritiS Inception Cohort
NCT03993847
  1. New Haven, Connecticut
  2. Boston, Massachusetts
  3. New York, New York
  4. Seattle, Washington
  5. Guadalajara, Jalisco
  6. San Francisco, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title CLassification of Axial SpondyloarthritiS Inception Cohort
Official Title CLassification of Axial SpondyloarthritiS Inception Cohort
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Undiagnosed back and/or buttock pain with onset ?45 years and duration ? 3 months
Condition Spondyloarthritis
Intervention Not Provided
Study Groups/Cohorts 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

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Amanda Carapellucci, BSc587-400-9524 ext 1004[email protected]
Listed Location Countries Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03993847
Other Study ID Numbers CLASSIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Undecided
Responsible Party Spondyloarthritis Research and Treatment Network
Study Sponsor Spondyloarthritis Research and Treatment Network
Collaborators
  • AbbVie
  • Amgen
  • Janssen Scientific Affairs, LLC
  • Eli Lilly and Company
  • Novartis Pharmaceuticals
  • Pfizer
  • UCB Pharma
Investigators
Principal Investigator:Walter P Maksymoywch, MDSpondyloarthritis Research and Treatment Network
PRS Account Spondyloarthritis Research and Treatment Network
Verification Date July 2020