SpondyloarthritisSPACANCT03564743
Description of Spondylarthritis and Validation of ASAS Criteria in West Indian Patients Seen in Consultation of Rheumatology.
An observational study of Spondyloarthritis, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
In 2004 an ASAS for the Assessment of SpondyloArthritis International Society decided to work to improve the criteria for classification of spondyloarthropathies to allow for early diagnosis, Nuclear magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Evaluation of ASAS criteria
- How many people
- 104 participants
- Where
- 1 siteMartinique
- Study dates
- Sep 2015to 1 Sep 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: Patient with presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005
Who may be able to join
- Patient over 18 years of age
- Patient seen in the usual framework of the consultation of rheumatology
- Patients consulting with:
- Presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005:
- Or with known sacroiliitis or asymmetric inflammatory rheumatism
- Or with chronic inflammatory bowel disease (Crohn, ulcerative colitis (RCH) ...) and associated inflammatory rheumatism
- Patients who received a lumbosacral MRI after 2005
- Patient not participating in a clinical trial
Who cannot join
- Patient under 18 years of age
- Patient participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Description of Spondylarthritis and Validation of Assessment of SpondyloArthritis International Society (ASAS) Criteria in West Indian Patients Seen in the Routine Consultation of Rheumatology.
In 2004 an ASAS for the Assessment of SpondyloArthritis International Society decided to work to improve the criteria for classification of spondyloarthropathies to allow for early diagnosis, Nuclear magnetic resonance imaging (MRI). This approach led to the publication in 2009 of the classification criteria for spondylarthritis, in particular axial spondyloarthritis, as well as a proposal to modify the classification of criteria defined by Mr. Amor (AMOR) and European Spondylarthropathy Study Group (ESSG) criteria, taking into account the potential abnormalities visible in Magnetic Resonance Imaging Nuclear (MRI).
The performance (specificity, sensitivity, positive and negative predictive values) of the ASAS criteria was then prospectively tested on a sample of the Metropolitan Caucasian population and this systematic study allowed to estimate the performance of the ASAS criteria in the usual framework Of the French Liberal Rheumatology Consultation.
Read more
Note that this approach is exposed to a criticism of "circular" approach, indeed the expert who is the gold standard for the diagnosis, uses more or less consciously "criteria" based on the presence of such and such sign, then checks in this selected population the diagnostic validity of these signs.
However, no data on the performance of ASAS criteria are available in populations of African descent.
Read the detailed description
Historically, spondyloarthritis is considered rare in these populations in the image of human Leukocyte Antigen B27 (HLA B27) which is observed only in 0.3% of individuals. Its presence determines the appearance of sacroiliitis - the cardinal sign of the disease - which is therefore rare. The recent contribution of MRI has changed investigators point of view and makes it possible to make the diagnosis in frequent situations but more atypical clinically.
In practice:
- ASAS signs are not systematically found in the West Indies (sacroiliitis, uveitis, cervicitis, urethritis, inflammatory syndrome, HLAB27 ...)
- Apart from cases associated with Chronic Inflammatory Bowel Disease (IBD), clinical panels are atypical and the ASAS criteria for little help
- MRI imaging is used to correct diagnosis. It is therefore necessary to describe these patients and to study the interest of the ASAS criteria in this population On the other hand, the validation of the ASAS criteria is part of the recommendations of treatment of the SPA (spondyloarthritis) by the French Society of Rheumatology in 2014. Clearly a patient who does not validate these criteria does not have access to anti- tumor necrosis factor (TNF) biotherapies, effective but Expensive. Thus, it is not known whether West Indian patients validate these criteria or not, but it is clear that despite the large number of local SPAs, few receive anti-TNF biotherapies.
The investigators propose to describe a population of Caribbean spondyloarthritis through a cross-sectional observational study carried out with a sample of rheumatologist doctors in three sites (Martinique, Guadeloupe, French Guyana). The methodology of the cluster survey of physicians, with a systematic evaluation of the first patients seen in consultation (chronological selection) provides the best guarantee of representativeness.
The interest of this work is to reproduce exactly the methodology of a previous work carried out in a Caucasian population, validated and published, and thus be able to compare the value of the ASAS criteria between the Caucasian and Caribbean populations.
- Conditions
- Spondyloarthritis
- Being tested
- Evaluation of ASAS criteria
- Keywords
- Spondyloarthritis, ASAS criteria, Diagnosis criteria, Classification criteria
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of ASAS criteriaDiagnostic test
Perform ASAS criteria at the time of physician diagnosis of chronic low back pain in rheumatological practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks.
Measured: September 2018
ASAS criteria
Assess the performance of ASAS criteria (sensitivity, specificity, positive predictive value, negative predictive value) at the time of physician's diagnosis of chronic low back pain in rheumatological practice (Evaluation of the concept of "diagnostic criteria" and Classification criteria).
Measured: September 2018
Secondary outcomes (1)
Assessment and comparison of ASAS performance against other classifications
Performance calculation of other classification systems (ESSG, Amor, New York modified): sensitivity, specificity, positive and negative predictive values.
Measured: September 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study startSep 2015
- Primary completionNov 2020
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel MD De Bandt, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564743
- Sponsor's protocol ID
- 14/E/20
- Acronym
- SPACA
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2017
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gran JT. An epidemiological survey of the signs and symptoms of ankylosing spondylitis. Clin Rheumatol. 1985 Jun;4(2):161-9. doi: 10.1007/BF02032287.
PubMed 3159533Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.
PubMed 1930310Amor B, Dougados M, Mijiyawa M. [Criteria of the classification of spondylarthropathies]. Rev Rhum Mal Osteoartic. 1990 Feb;57(2):85-9. French.
PubMed 2181618van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361-8. doi: 10.1002/art.1780270401.
PubMed 6231933Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann Rheum Dis. 2009 Jun;68(6):784-8. doi: 10.1136/ard.2008.101501. Epub 2009 Jan 15.
PubMed 19147614Boy FN, Kayhan A, Karakas HM, Unlu-Ozkan F, Silte D, Aktas I. The role of multi-parametric MR imaging in the detection of early inflammatory sacroiliitis according to ASAS criteria. Eur J Radiol. 2014 Jun;83(6):989-996. doi: 10.1016/j.ejrad.2014.03.002. Epub 2014 Mar 22.
PubMed 24703519Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.
PubMed 3358796Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
PubMed 20872595
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Description of Spondylarthritis and Validation of Assessment of SpondyloArthritis International Society (ASAS) Criteria in West Indian Patients Seen in the Routine Consultation of Rheumatology.
- ClinicalTrials.gov ID
- NCT03564743
- Acronym / sponsor ID
- SPACA / 14/E/20
- Conditions
- Spondyloarthritis
- Keywords
- Spondyloarthritis, ASAS criteria, Diagnosis criteria, Classification criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Jun 2018 (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.
In 2004 an ASAS for the Assessment of SpondyloArthritis International Society decided to work to improve the criteria for classification of spondyloarthropathies to allow for early diagnosis, Nuclear magnetic resonance imaging (MRI). This approach led to the publication in 2009 of the classification criteria for spondylarthritis, in particular axial spondyloarthritis, as well as a proposal to modify the classification of criteria defined by Mr. Amor (AMOR) and European Spondylarthropathy Study Group (ESSG) criteria, taking into account the potential abnormalities visible in Magnetic Resonance Imaging Nuclear (MRI).
The performance (specificity, sensitivity, positive and negative predictive values) of the ASAS criteria was then prospectively tested on a sample of the Metropolitan Caucasian population and this systematic study allowed to estimate the performance of the ASAS criteria in the usual framework Of the French Liberal Rheumatology Consultation.
Note that this approach is exposed to a criticism of "circular" approach, indeed the expert who is the gold standard for the diagnosis, uses more or less consciously "criteria" based on the presence of such and such sign, then checks in this selected population the diagnostic validity of these signs.
However, no data on the performance of ASAS criteria are available in populations of African descent.
Detailed description
Historically, spondyloarthritis is considered rare in these populations in the image of human Leukocyte Antigen B27 (HLA B27) which is observed only in 0.3% of individuals. Its presence determines the appearance of sacroiliitis - the cardinal sign of the disease - which is therefore rare. The recent contribution of MRI has changed investigators point of view and makes it possible to make the diagnosis in frequent situations but more atypical clinically.
In practice:
- ASAS signs are not systematically found in the West Indies (sacroiliitis, uveitis, cervicitis, urethritis, inflammatory syndrome, HLAB27 ...)
- Apart from cases associated with Chronic Inflammatory Bowel Disease (IBD), clinical panels are atypical and the ASAS criteria for little help
- MRI imaging is used to correct diagnosis. It is therefore necessary to describe these patients and to study the interest of the ASAS criteria in this population On the other hand, the validation of the ASAS criteria is part of the recommendations of treatment of the SPA (spondyloarthritis) by the French Society of Rheumatology in 2014. Clearly a patient who does not validate these criteria does not have access to anti- tumor necrosis factor (TNF) biotherapies, effective but Expensive. Thus, it is not known whether West Indian patients validate these criteria or not, but it is clear that despite the large number of local SPAs, few receive anti-TNF biotherapies.
The investigators propose to describe a population of Caribbean spondyloarthritis through a cross-sectional observational study carried out with a sample of rheumatologist doctors in three sites (Martinique, Guadeloupe, French Guyana). The methodology of the cluster survey of physicians, with a systematic evaluation of the first patients seen in consultation (chronological selection) provides the best guarantee of representativeness.
The interest of this work is to reproduce exactly the methodology of a previous work carried out in a Caucasian population, validated and published, and thus be able to compare the value of the ASAS criteria between the Caucasian and Caribbean populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005
Key inclusion criteria (8 listed)
- Patient over 18 years of age
- Patient seen in the usual framework of the consultation of rheumatology
- Patients consulting with:
- Presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005:
- Or with known sacroiliitis or asymmetric inflammatory rheumatism
Key exclusion criteria (2 listed)
- Patient under 18 years of age
- Patient participating in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of ASAS criteriaPerform ASAS criteria at the time of physician diagnosis of chronic low back pain in rheumatological practice. | Diagnostic test | – |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: September 2018
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks.
ASAS criteria
Time frame: September 2018
Assess the performance of ASAS criteria (sensitivity, specificity, positive predictive value, negative predictive value) at the time of physician's diagnosis of chronic low back pain in rheumatological practice (Evaluation of the concept of "diagnostic criteria" and Classification criteria).
1 secondary outcome
Assessment and comparison of ASAS performance against other classifications
Time frame: September 2018
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 19 Jul 2023.
- Background: PubMed 3159533Gran JT. An epidemiological survey of the signs and symptoms of ankylosing spondylitis. Clin Rheumatol. 1985 Jun;4(2):161-9. doi: 10.1007/BF02032287.
- Background: PubMed 1930310Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.
- Background: PubMed 2181618Amor B, Dougados M, Mijiyawa M. [Criteria of the classification of spondylarthropathies]. Rev Rhum Mal Osteoartic. 1990 Feb;57(2):85-9. French.
- Background: PubMed 6231933van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361-8. doi: 10.1002/art.1780270401.
- Background: PubMed 19147614Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann Rheum Dis. 2009 Jun;68(6):784-8. doi: 10.1136/ard.2008.101501. Epub 2009 Jan 15.
- Background: PubMed 24703519Boy FN, Kayhan A, Karakas HM, Unlu-Ozkan F, Silte D, Aktas I. The role of multi-parametric MR imaging in the detection of early inflammatory sacroiliitis according to ASAS criteria. Eur J Radiol. 2014 Jun;83(6):989-996. doi: 10.1016/j.ejrad.2014.03.002. Epub 2014 Mar 22.
- Background: PubMed 3358796Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.
- Background: PubMed 20872595Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
- Individual participant dataSharing planned: No
Related trials for Spondyloarthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Michel MD De Bandt principal investigator
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis, run by University Hospital Center of Martinique at 1 site in Martinique.
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 8 inclusion and 2 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: September 2018). The study lists 2 primary outcomes in all. 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 NCT03564743, which also lists 8 linked publications.
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 19 Jul 2023.