EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES Clinical Trial
— DESIROfficial title:
French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis
| Verified date | October 2022 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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 pain and spondyloarthritis
| Status | Completed |
| Enrollment | 708 |
| Est. completion date | February 23, 2022 |
| Est. primary completion date | June 20, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | Inclusion Criteria: - 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 - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Department of Rheumatology, Cochin Hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
Dougados M, d'Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daurès 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, W — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 5 years | |
| Secondary | 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 | 5 years | |
| Secondary | 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 | 5 years | |
| Secondary | 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 | 2 years | |
| Secondary | Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years | 5 years | ||
| Secondary | Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years | 5 years | ||
| Secondary | Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment | 5 years |