EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIESDESIRNCT01648907

French Cohort of Undifferentiated Spondyloarthritis

An observational study of EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is a large national multicenter, longitudinal, prospective follow-up of patients presenting with early inflammatory back pain in order to set up a database to facilitate several investigations on diagnosis, prognosis, epidemiology, pathogenesis and medico-economics in the field of early inflammatory back… Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES
What is being tested?: Imaging exams
How many people: 708 participants
Where: 1 siteFrance
Study dates: 15 Oct 2007to 23 Feb 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 to 50 years
All sexes
No healthy volunteers
Adult

Study population: Patients presenting early inflammatory back pain of more than 3 months and less than 3 years

Who may be able to join

Patients aged over 18 and under 50 years
Inflammatory back pain (buttock, lumbar or thoracic spine) fulfilling either the Calin orBerlin criteria :
Calin criteria (at least 4 of 5 criteria must be met) (ref. 25):
Insidious onset
Onset before age 40
Persistence since at least three months

Show all 17Show fewer

Morning stiffness 30 minutes
Improvement with exercise
Berlin criteria (at least 2 of 4 criteria must be met) (ref. 26):
Morning stiffness 30 minutes
Improvement with exercise and absence of improvement at rest
Nocturnal pain in the second part of the night
Alternating buttock pain
Symptom duration more than 3 months and less than 3 years
Symptoms suggestive of spondyloarthritis according to the local investigator's assessment(e.g. score ≥5 on a 0 to 10 numerical rating scale in which 0 = no suggestive and 10 = verysuggestive of spondyloarthritis)
Realization of a prior medical examination (article L.1121-11 of the Code of the Public health)
Informed consent Dated and signed voluntarily

Who cannot join

Other spinal disease clearly defined (eg symptomatic mechanical discopathy)
Pregnant woman
History of alcoholism, drug addiction, psychological problems, severe co-morbidities which might interfere with the validity of the informed consent and/or prevent an optimal compliance of the patient to the cohort
It was possible to include patients who have received or are receiving a thorough treatment such as Sulfasalazine, Methotrexate or Azathioprine. However any history of treatment with biotherapy including anti-TNF therapy defined exclusion criteria
Corticosteroid intake was permitted only in case of a dose lower than 10 mg prednisoneper day and stable for at least 4 weeks prior baseline
MRI contraindication
No affiliation to the French National Social Security System

Trial locations and contacts

1 site in 1 country.

France1 site

Department of Rheumatology, Cochin Hospital
Paris, 75014

Other trials in France

About this study

Official title: French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis

Read the detailed description

This large national multicenter, longitudinal, prospective follow-up of patients presenting with early inflammatory back pain in order to set up a database to facilitate several investigations on diagnosis, prognosis, epidemiology, pathogenesis and medico-economics in the field of early inflammatory back pain and spondyloarthritis.

The Patients were recruited if they had inflammatory back pain of more than 3months and less than 3years. Patients will be followed every 6months during the first 2years then every year during at least 5years. Apart from information collected on a Case Report Form (demographics, disease activity, severity, co-morbidities, socio-economics, treatments, radiological and MRI evaluation of the spine and the pelvis according to the local investigators, and for some centers bone densitometry and ultrasonography of entheses), the digital X-rays and MRI of the spine and pelvis are stored using a specific software (Carestream) and the biological samples (DNA, RNA, sera, urines) are centralized at the Biological Resources Center (Bichat Hospital).

This large cohort should facilitate the conduct of researches in different areas (clinical, medico-economics, translational) in order to improve our knowledge on the pathogenesis and natural history of axial spondyloarthritis

Conditions: EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES
Being tested: Imaging exams
Keywords: DESIR, SPONDYLARTHRITIS, EARLY INFLAMMATORY RACHIIALGIA, BACK PAIN
Medical subject headings: Spondylarthritis, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Imaging examsOther
Also called Radiological examinations, Bone densitometry, Enthesis ultrasound, Biological tests
Radiological examinations:
- Standard x-ray: they include an x-ray of the cervical, thoracic, and lumbar spine (side-on), of the lumbar spine from the front and an x-ray of the pelvis from the front
- MRI scan: are taken of the cervical, thoracic and lumbar spine and sacroiliac joints.
Bone densitometry: evaluation of bone densitometry of the lumbar spine and femoral neck.
Enthesis ultrasound: bilateral evaluation of entheseal insertions for the Achilles tendon, patella tendons and epicondyle tendons.
Biological tests :
- Genetic test : DNA will be collected at the first visit from all centers. RNA will be collected at the inclusion visit in AP-HP centres only.
- Serum will be collected by all centres at the initial visit, then in M6, M12 and M24 for the first two years of the study, then in M60.
- Urine will be collected by all centres at the initial visit, then in M24 for the first two years of the study, then in M60.

Study groups in NCT01648907
Study group	Role	What they receive
SPONDYLARTHRITIS COHORT		Not described Receives: Other: Imaging exams

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiological sacroiliitis
Percentage of patients after 5 years of evolution, that will have a radiological sacroiliitis according to the presence or absence of the sacroiliac inflammatory abnormalities of the sacroiliac joints at study entry on MRI
Measured: 5 years

Secondary outcomes (6)

Predictive biomarker(s) of structural radiographic or IRM progression in SpA
To identify biomarker(s) of bone formation (DKK-1, sclérostin, BMP-7, périostin) which are predictive of structural radiographic progression and in IRM at 5 years
Measured: 5 years
Changes of level of biomarkers in the disease in 5 years
To assess the 5-year changes in of serum periostin, serum sclerostin, DKK-1 and BMP-7 in a large population of early axial SpA
Measured: 5 years
Changes of level of biomarkers in the disease in 2 years
To assess the 2-year changes in of serum periostin, serum sclerostin, DKK-1 and BMP-7 in a large population of early axial SpA
Measured: 2 years
Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years
Measured: 5 years
Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years
Measured: 5 years
Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 200723 Feb 2022

First posted24 Jul 2012 (estimated)
Study start15 Oct 2007
Primary completion20 Jun 2016
Study completion23 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIESStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
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: 708 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01648907
Sponsor's protocol ID: P070302
Other IDs: IDRCB 2007-A00608-45
Acronym: DESIR
Status last verified: Mar 2026
First submitted: 20 Jul 2012
Last updated: 10 Mar 2026
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Dougados M, d'Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daures JP, Fautrel B, Feydy A, Goupille P, Leblanc V, Logeart I, Pham T, Richette P, Roux C, Rudwaleit M, Saraux A, Treluyer JM, van der Heijde D, Wendling D. The DESIR cohort: a 10-year follow-up of early inflammatory back pain in France: study design and baseline characteristics of the 708 recruited patients. Joint Bone Spine. 2011 Dec;78(6):598-603. doi: 10.1016/j.jbspin.2011.01.013. Epub 2011 Mar 31.
PubMed 21458351
Chung HY, Machado P, van der Heijde D, D'Agostino MA, Dougados M. HLA-B27 positive patients differ from HLA-B27 negative patients in clinical presentation and imaging: results from the DESIR cohort of patients with recent onset axial spondyloarthritis. Ann Rheum Dis. 2011 Nov;70(11):1930-6. doi: 10.1136/ard.2011.152975. Epub 2011 Jul 28.
PubMed 21803752
Fakih O, Molto A, Verhoeven F, Prati C, Wendling D. Incidence, baseline-associated factors and burden of difficult-to-manage axial spondyloarthritis: a 10-year analysis of the DESIR cohort. RMD Open. 2026 Sep 7;12(3):e007094. doi: 10.1136/rmdopen-2026-007094.
PubMed 42705859
Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Erosions on T1-Weighted Magnetic Resonance Imaging Versus Radiography of Sacroiliac Joints in Recent-Onset Axial Spondyloarthritis: 2-Year Data (EMBARK Trial and DESIR Cohort). J Rheumatol. 2024 May 1;51(5):462-471. doi: 10.3899/jrheum.2023-0906.
PubMed 38359938
Aouad K, Tournadre A, Lucasson F, Wendling D, Molto A, Fautrel B, Gossec L. Influence of Sex on Early Axial Spondyloarthritis: A Six-Year Longitudinal Analysis From a Large National Cohort. Arthritis Care Res (Hoboken). 2023 Oct;75(10):2107-2116. doi: 10.1002/acr.25103. Epub 2023 Mar 15.
PubMed 36785996
Ruyssen-Witrand A, Rousseau V, Sommet A, Goupille P, Degboe Y, Constantin A. Factors associated with drug-free remission at 5-year in early onset axial spondyloarthritis patients: Data from the DESIR cohort. Joint Bone Spine. 2022 Jul;89(4):105358. doi: 10.1016/j.jbspin.2022.105358. Epub 2022 Feb 12.
PubMed 35167972
Lucasson F, Richette P, Aouad K, Ryussen-Witrand A, Wendling D, Fautrel B, Gossec L. Prevalence and consequences of psoriasis in recent axial spondyloarthritis: an analysis of the DESIR cohort over 6 years. RMD Open. 2022 Jan;8(1):e001986. doi: 10.1136/rmdopen-2021-001986.
PubMed 35091462
Costantino F, Aegerter P, Schett G, De Craemer AS, Molto A, Van den Bosch F, Elewaut D, Breban M, D'Agostino MA. Cluster analysis in early axial spondyloarthritis predicts poor outcome in the presence of peripheral articular manifestations. Rheumatology (Oxford). 2022 Aug 3;61(8):3289-3298. doi: 10.1093/rheumatology/keab873.
PubMed 34864930
Kumaradev S, Roux C, Sellam J, Perrot S, Pham T, Dugravot A, Molto A. Socio-demographic determinants in the evolution of pain in inflammatory rheumatic diseases: results from ESPOIR and DESIR cohorts. Rheumatology (Oxford). 2022 Apr 11;61(4):1496-1509. doi: 10.1093/rheumatology/keab562.
PubMed 34270700
Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Structural changes in the sacroiliac joint on MRI and relationship to ASDAS inactive disease in axial spondyloarthritis: a 2-year study comparing treatment with etanercept in EMBARK to a contemporary control cohort in DESIR. Arthritis Res Ther. 2021 Jan 29;23(1):43. doi: 10.1186/s13075-021-02428-8.
PubMed 33514428
Carvalho PD, Ruyssen-Witrand A, Marreiros A, Machado PM. Long-Term Association Between Disease Activity and Disability in Early Axial Spondyloarthritis: Results From a Prospective Observational Study of Inflammatory Back Pain. Arthritis Care Res (Hoboken). 2022 May;74(5):768-775. doi: 10.1002/acr.24515. Epub 2022 Mar 7.
PubMed 33207078
Descamps E, Molto A, Borderie D, Lories R, Richard CM, Pons M, Roux C, Briot K. Changes in bone formation regulator biomarkers in early axial spondyloarthritis. Rheumatology (Oxford). 2021 Mar 2;60(3):1185-1194. doi: 10.1093/rheumatology/keaa296.
PubMed 32888036
Lopez-Medina C, Molto A, Claudepierre P, Dougados M. Clinical manifestations, disease activity and disease burden of radiographic versus non-radiographic axial spondyloarthritis over 5 years of follow-up in the DESIR cohort. Ann Rheum Dis. 2020 Feb;79(2):209-216. doi: 10.1136/annrheumdis-2019-216218. Epub 2019 Nov 29.
PubMed 31784451
Ruyssen-Witrand A, Luxembourger C, Cantagrel A, Nigon D, Claudepierre P, Degboe Y, Constantin A. Association between IL23R and ERAP1 polymorphisms and sacroiliac or spinal MRI inflammation in spondyloarthritis: DESIR cohort data. Arthritis Res Ther. 2019 Jan 15;21(1):22. doi: 10.1186/s13075-018-1807-5.
PubMed 30646942
Dougados M, Maksymowych WP, Landewe RBM, Molto A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis. 2018 Feb;77(2):221-227. doi: 10.1136/annrheumdis-2017-212008. Epub 2017 Sep 29.
PubMed 28970213

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis
ClinicalTrials.gov ID: NCT01648907
Acronym / sponsor ID: DESIR / P070302
Conditions: EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES
Keywords: DESIR, SPONDYLARTHRITIS, EARLY INFLAMMATORY RACHIIALGIA, BACK PAIN
Study type: Observational
Recruitment status: Completed
Enrolment: 708 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Collaborators: URC-CIC Paris Descartes Necker Cochin
Study start: 15 Oct 2007 (actual)
Primary completion: 20 Jun 2016 (actual)
Study completion: 23 Feb 2022 (actual)
First posted: 24 Jul 2012 (estimated)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
SPONDYLARTHRITIS COHORT	–	Other: Imaging exams

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Patients presenting early inflammatory back pain of more than 3 months and less than 3 years

Key inclusion criteria (17 listed)

Patients aged over 18 and under 50 years
Inflammatory back pain (buttock, lumbar or thoracic spine) fulfilling either the Calin orBerlin criteria :
Calin criteria (at least 4 of 5 criteria must be met) (ref. 25):
Insidious onset
Onset before age 40

Key exclusion criteria (7 listed)

Other spinal disease clearly defined (eg symptomatic mechanical discopathy)
Pregnant woman
History of alcoholism, drug addiction, psychological problems, severe co-morbidities which might interfere with the validity of the informed consent and/or prevent an optimal compliance of the patient to the cohort
It was possible to include patients who have received or are receiving a thorough treatment such as Sulfasalazine, Methotrexate or Azathioprine. However any history of treatment with biotherapy including anti-TNF therapy defined exclusion criteria
Corticosteroid intake was permitted only in case of a dose lower than 10 mg prednisoneper day and stable for at least 4 weeks prior baseline

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
Imaging examsAlso: Radiological examinations, Bone densitometry, Enthesis ultrasound, Biological testsRadiological examinations: * Standard x-ray: they include an x-ray of the cervical, thoracic, and lumbar spine (side-on), of the lumbar spine from the front and an x-ray of the pelvis from the front * MRI scan: are taken of the cervical, thoracic and lumbar spine and sacroiliac joints. Bone densitometry: evaluation of bone densitometry of the lumbar spine and femoral neck. Enthesis ultrasound: bilateral evaluation of entheseal insertions for the Achilles tendon, patella tendons and epicondyle tendons. Biological tests : * Genetic test : DNA will be collected at the first visit from all centers. RNA will be collected at the inclusion visit in AP-HP centres only. * Serum will be collected by all centres at the initial visit, then in M6, M12 and M24 for the first two years of the study, then in M60. * Urine will be collected by all centres at the initial visit, then in M24 for the first two years of the study, then in M60.	Other	SPONDYLARTHRITIS COHORT

Primary outcome

Radiological sacroiliitis
Time frame: 5 years
Percentage of patients after 5 years of evolution, that will have a radiological sacroiliitis according to the presence or absence of the sacroiliac inflammatory abnormalities of the sacroiliac joints at study entry on MRI

6 secondary outcomes

Predictive biomarker(s) of structural radiographic or IRM progression in SpA
Time frame: 5 years
Changes of level of biomarkers in the disease in 5 years
Time frame: 5 years
Changes of level of biomarkers in the disease in 2 years
Time frame: 2 years
Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years
Time frame: 5 years
Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years
Time frame: 5 years
Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment
Time frame: 5 years

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 10 Mar 2026.
Results publication: PubMed 21458351Dougados M, d'Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daures JP, Fautrel B, Feydy A, Goupille P, Leblanc V, Logeart I, Pham T, Richette P, Roux C, Rudwaleit M, Saraux A, Treluyer JM, van der Heijde D, Wendling D. The DESIR cohort: a 10-year follow-up of early inflammatory back pain in France: study design and baseline characteristics of the 708 recruited patients. Joint Bone Spine. 2011 Dec;78(6):598-603. doi: 10.1016/j.jbspin.2011.01.013. Epub 2011 Mar 31.
Results publication: PubMed 21803752Chung HY, Machado P, van der Heijde D, D'Agostino MA, Dougados M. HLA-B27 positive patients differ from HLA-B27 negative patients in clinical presentation and imaging: results from the DESIR cohort of patients with recent onset axial spondyloarthritis. Ann Rheum Dis. 2011 Nov;70(11):1930-6. doi: 10.1136/ard.2011.152975. Epub 2011 Jul 28.
Derived from this study: PubMed 42705859Fakih O, Molto A, Verhoeven F, Prati C, Wendling D. Incidence, baseline-associated factors and burden of difficult-to-manage axial spondyloarthritis: a 10-year analysis of the DESIR cohort. RMD Open. 2026 Sep 7;12(3):e007094. doi: 10.1136/rmdopen-2026-007094.
Derived from this study: PubMed 38359938Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Erosions on T1-Weighted Magnetic Resonance Imaging Versus Radiography of Sacroiliac Joints in Recent-Onset Axial Spondyloarthritis: 2-Year Data (EMBARK Trial and DESIR Cohort). J Rheumatol. 2024 May 1;51(5):462-471. doi: 10.3899/jrheum.2023-0906.
Derived from this study: PubMed 36785996Aouad K, Tournadre A, Lucasson F, Wendling D, Molto A, Fautrel B, Gossec L. Influence of Sex on Early Axial Spondyloarthritis: A Six-Year Longitudinal Analysis From a Large National Cohort. Arthritis Care Res (Hoboken). 2023 Oct;75(10):2107-2116. doi: 10.1002/acr.25103. Epub 2023 Mar 15.
Derived from this study: PubMed 35167972Ruyssen-Witrand A, Rousseau V, Sommet A, Goupille P, Degboe Y, Constantin A. Factors associated with drug-free remission at 5-year in early onset axial spondyloarthritis patients: Data from the DESIR cohort. Joint Bone Spine. 2022 Jul;89(4):105358. doi: 10.1016/j.jbspin.2022.105358. Epub 2022 Feb 12.
Derived from this study: PubMed 35091462Lucasson F, Richette P, Aouad K, Ryussen-Witrand A, Wendling D, Fautrel B, Gossec L. Prevalence and consequences of psoriasis in recent axial spondyloarthritis: an analysis of the DESIR cohort over 6 years. RMD Open. 2022 Jan;8(1):e001986. doi: 10.1136/rmdopen-2021-001986.
Derived from this study: PubMed 34864930Costantino F, Aegerter P, Schett G, De Craemer AS, Molto A, Van den Bosch F, Elewaut D, Breban M, D'Agostino MA. Cluster analysis in early axial spondyloarthritis predicts poor outcome in the presence of peripheral articular manifestations. Rheumatology (Oxford). 2022 Aug 3;61(8):3289-3298. doi: 10.1093/rheumatology/keab873.
Derived from this study: PubMed 34270700Kumaradev S, Roux C, Sellam J, Perrot S, Pham T, Dugravot A, Molto A. Socio-demographic determinants in the evolution of pain in inflammatory rheumatic diseases: results from ESPOIR and DESIR cohorts. Rheumatology (Oxford). 2022 Apr 11;61(4):1496-1509. doi: 10.1093/rheumatology/keab562.
Derived from this study: PubMed 33514428Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Structural changes in the sacroiliac joint on MRI and relationship to ASDAS inactive disease in axial spondyloarthritis: a 2-year study comparing treatment with etanercept in EMBARK to a contemporary control cohort in DESIR. Arthritis Res Ther. 2021 Jan 29;23(1):43. doi: 10.1186/s13075-021-02428-8.
Derived from this study: PubMed 33207078Carvalho PD, Ruyssen-Witrand A, Marreiros A, Machado PM. Long-Term Association Between Disease Activity and Disability in Early Axial Spondyloarthritis: Results From a Prospective Observational Study of Inflammatory Back Pain. Arthritis Care Res (Hoboken). 2022 May;74(5):768-775. doi: 10.1002/acr.24515. Epub 2022 Mar 7.
Derived from this study: PubMed 32888036Descamps E, Molto A, Borderie D, Lories R, Richard CM, Pons M, Roux C, Briot K. Changes in bone formation regulator biomarkers in early axial spondyloarthritis. Rheumatology (Oxford). 2021 Mar 2;60(3):1185-1194. doi: 10.1093/rheumatology/keaa296.
Individual participant dataSharing planned: No

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.

Maxime DOUGADOS, MD principal investigator

Cochin Hospital

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 EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 17 inclusion and 7 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 10 Mar 2026. 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 France. 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?

Radiological sacroiliitis (time frame: 5 years). 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 NCT01648907, which also lists 19 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 10 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.