SpondyloarthritisCLASSICNCT03993847
CLassification of Axial SpondyloarthritiS Inception Cohort
An observational study of Spondyloarthritis, run by Spondyloarthritis Research and Treatment Network at 20 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- How many people
- 501 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 4 Dec 2019to 22 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Undiagnosed back and/or buttock pain with onset ≤45 years and duration ≥ 3 months
Who may be able to join
- 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:
Who cannot join
- 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)
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States15 sites
University of Colorado
Aurora, Colorado, 80045
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Boston University School of Medicine
Boston, Massachusetts, 02118
Cleveland Clinic
Cleveland, Ohio, 44195
Dallas VA Medical Center VANTHCS
Dallas, Texas, 75216
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
VA Long Beach Healthcare System
Long Beach, California, 90822
Sacramento VA Medical Center
Mather, California, 95655
Yale University School of Medicine
New Haven, Connecticut, 06067
Columbia University
New York, New York, 10032
Oregon Health & Science University
Portland, Oregon, 97239
UCSF Medical Center - Rheumatology Clinic
San Francisco, California, 94143
Seattle Rheumatology Associates
Seattle, Washington, 98122
James J. Peters VAMC
The Bronx, New York, 10468
Canada3 sites
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
University Health Network
Toronto, Ontario, M5T2S8
Artus Health Center
Vancouver, British Columbia, V5Z 1L9
Mexico2 sites
Centro de Estudios de Investigacion Basica y Clinica, SC
Guadalajara, Jalisco, 44690
CLIDITER
Mexico City, Mexico City, 06700
About this study
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.
Read the 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.
- Conditions
- Spondyloarthritis
- Keywords
- Spondyloarthritis, SPARTAN, ASAS, SpA, Undiagnosed Back Pain
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation.
Physician will answer Yes or No.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start4 Dec 2019
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spondyloarthritis Research and Treatment Network
- Sponsor type
- Research network
- Collaborators
- AbbVie, Amgen, Janssen Scientific Affairs, LLC, Eli Lilly and Company, Novartis Pharmaceuticals, Pfizer, UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Walter P Maksymoywch, MD, Principal investigator, Spondyloarthritis Research and Treatment Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993847
- Sponsor's protocol ID
- CLASSIC
- Acronym
- CLASSIC
- Status last verified
- Dec 2022
- First submitted
- 12 Jun 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38656252
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLassification of Axial SpondyloarthritiS Inception Cohort
- ClinicalTrials.gov ID
- NCT03993847
- Acronym / sponsor ID
- CLASSIC / CLASSIC
- Conditions
- Spondyloarthritis
- Keywords
- Spondyloarthritis, SPARTAN, ASAS, SpA, Undiagnosed Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Spondyloarthritis Research and Treatment NetworkResearch network
- Collaborators
- AbbVie, Amgen, Janssen Scientific Affairs, LLC, Eli Lilly and Company, Novartis Pharmaceuticals, Pfizer, UCB Pharma
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Undiagnosed back and/or buttock pain with onset ≤45 years and duration ≥ 3 months
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation.
Time frame: 6 weeks
Physician will answer Yes or No.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Derived from this study: PubMed 38656252Helliwell 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter P Maksymoywch, MD principal investigator
Spondyloarthritis Research and Treatment Network
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis, run by Spondyloarthritis Research and Treatment Network at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician diagnosis of axial spondyloarthritis at the final diagnostic evaluation. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.