Justification of the Initial Diagnosis and Evaluation of the Overall Evolution of a Cohort of Recent Polymyalgia Rheumatica (JADORE)
JADORE
2 other identifiers
observational
400
1 country
30
Brief Summary
Pseudo-rheumatoid arthritis (PRA) is a common inflammatory rheumatic disease of the elderly, characterized by inflammatory shoulder and/or hip pain. Its routine diagnosis is based on a number of clinical criteria, the presence of a biological inflammatory syndrome and the elimination of the main differential diagnoses. It is sometimes referred to as PPR syndrome, since around 25% of initial diagnoses are not confirmed at one year's follow-up (PPR syndrome revealing rheumatoid arthritis, microcrystalline rheumatism, etc.). Diagnosis may be facilitated by ultrasound scans of the shoulders and hips, which may show characteristic inflammatory lesions, or by PET scans when there is a marked deterioration in general condition or other clinical atypia. PPR may be associated at the outset, or it may evolve into the rarer vasculitis of the elderly, giant cell arteritis (GCA), a condition that can lead to severe and irreversible neurological vascular damage if not treated early. Prolonged, moderate-dose corticosteroid therapy is the cornerstone of PPR treatment, although new treatments are in the process of obtaining marketing authorization to enable cortisone sparing. Anti-IL-6 agents, and in particular Tocilizumab, have demonstrated their efficacy in recent cortico-dependent PPR, Sarilumab has obtained marketing authorization for cortico-dependent PPR in the USA in 2023, and other therapeutic classes are currently being evaluated in this situation. Recommendations, including those of ACR/EULAR in 2015, advise a strategy of initiating corticosteroid therapy at a moderate dose, with a dosage of between 12.5 and 25 mg prednisone equivalent per day, and gradually tapering off with the aim of reaching a dosage of 10 mg prednisone equivalent per day at week 8, to achieve complete weaning at 12 months. However, on the one hand, these recommendations are not based on clinical trials and, on the other, the main comorbidities associated with PPR are related to this long-term corticosteroid therapy. Lastly, we know that around 50% of patients do not follow this tapering-off protocol, with either relapses (estimated at 50% during tapering) or the impossibility for around 25% of patients to stop corticosteroid therapy. However, there are currently no predictive factors for the evolution of PPR. PPR activity can be measured either using a validated score, the DAS-PPR, or according to the opinion of the rheumatologist. Good progression of rheumatoid arthritis is characterized by a low activity score (DAS-PPR\<10) and, wherever possible, discontinuation of treatment within one year, as recommended by international experts. The main objective of this cohort is therefore to evaluate the percentage of patients with low-activity PPR (DAS-PPR\<10) and no treatment at 12 months. Secondary objectives will concern the initial phenotypic and evolutionary description of PPR (complete initial phenotypic characteristics, including some exploratory ones (imaging, biology, immunology, genetics, microbiota, avatars). The evolution of the disease, with the percentage of relapses during the decline or distant relapses, percentage of association with ACG, mortality rate, as well as the prognostic factors of these different evolutionary forms. A description of the disease-modifying treatments used (corticosteroid therapy and its decline, other immunomodulators), as well as a record of the complications presented by patients (development of ACG, corticosteroid toxicity, sarcopenia, osteoporosis fractures, diverticular perforation). Finally, many pathologies can clinically and biologically mimic PPR, leading to erroneous prescriptions of glucocorticoids for prolonged periods, and sometimes a delay in the diagnosis of serious conditions. These classic differential diagnoses will be investigated according to the clinical context and the clinician's judgement, and the diagnostic value of tests such as joint ultrasound, PET scans and biomarkers can be assessed. With regard to patient follow-up, if an alternative diagnosis is identified immediately after the completion of additional examinations, the patient is no longer followed up in the study, and the alternative diagnosis is noted by the investigator. For patients for whom the investigator's conviction concerning the diagnosis of PPR remains above 50%, as at inclusion, follow-up in the study is continued. At one year's follow-up, if an alternative diagnosis has been made, this is collected and the patient is no longer followed up in the cohort. Follow-up for other patients then continues for 5 years. Deterministic matching to the SNDS will be performed for each patient included. To date, there is no French prospective cohort dedicated to the follow-up of patients with a recent form of PPR, as has been done for rheumatoid arthritis, spondyloarthritis and psoriatic arthritis. The creation of such a cohort will improve our knowledge of this pathology, in terms of both pathophysiology and routine management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2025
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2025
CompletedFirst Posted
Study publicly available on registry
August 20, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2034
August 20, 2025
August 1, 2025
5 years
July 8, 2025
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Measurement of DAS-PPR (Disease Activity Score)
12 months
Number of participants with no PPR-related treatment for at least 2 weeks
12 months
Secondary Outcomes (33)
Number of patients with a Diagnosis of PPR maintained
Months 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
Classification criteria ACR/EULAR (American College of Rheumatology/European Alliance of associations for rheumatology) 2012
Inclusion
Shoulder and hip ultrasound score
Inclusion
Measurement of the Leuven score
Inclusion
Definitive diagnosis of PRA according to the expert clinican
Month 24
- +28 more secondary outcomes
Study Arms (1)
Biological sample collection
Biobank establishment and stool sample collection for gut microbiota analysis
Interventions
At inclusion, patients will benefit from blood testing for biobank establishment, and stool sample collection for gut microbiota analysis will be organized depending on the center. The 12-month visit (M12) will also include an additional blood sample collection as part of the biobank, as well as stool sample collection
Eligibility Criteria
Patients agreeing to take part in the study and meeting the inclusion and non-inclusion criteria will be referred to the nearest rheumatology department participating in the study
You may qualify if:
- Age greater than or equal to 50, with no upper age limit
- Inflammatory shoulder +/- hip pain
- Abnormal CRP (≥10mg/L)
- Patients for whom the referring rheumatologist accepts the diagnosis of PPR after carrying out the assessment corresponding to his or her current practice
- Patients for whom the referring rheumatologist has indicated that corticosteroid therapy should be started in the strict context of PPR or as background treatment for PPR.
- Symptoms have progressed for 24 weeks or less
You may not qualify if:
- Presence, at the time of diagnosis, of symptoms and/or signs suggesting a diagnosis of associated giant cell arteritis
- Immuno-induced PPR
- Patients who have received corticosteroid therapy for more than 30 days or a cumulative dose of more than 500 mg of Prednisone equivalent in the month preceding the screening visit.
- Patients with another chronic condition requiring long-term corticosteroid therapy or repeated courses of corticosteroids.
- Patients not affiliated to a social security scheme
- Patients unable to consent or unable or unwilling to complete their corticosteroid dose monitoring record.
- Pregnancy
- Patients under guardianship, curatorship or safeguard of justice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
CHU Rouen
Rouen, Rouen, 76038, France
Besançon-CIC
Besançon, 25000, France
CHU Besançon
Besançon, 25030, France
CHU de Bordeaux Pellegrin
Bordeaux, 33076, France
CH Boulogne/mer
Boulogne-sur-Mer, 62321, France
CHU de Brest
Brest, 29609, France
CHU de Caen
Caen, 14033, France
Clinique de l'Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300, France
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
CH Dax
Dax, 40107, France
CHU de Dijon
Dijon, 21000, France
CH La Roche s/ Yon
La Roche-sur-Yon, 85925, France
APHP - Kremlin-Bicêtre
Le Kremlin-Bicêtre, 94270, France
CH Le Mans
Le Mans, 72037, France
CHU de Lille
Lille, 59037, France
Institut catholique de Lille
Lomme, 59160, France
CHU Marseille AP-HM
Marseille, 13009, France
CH Le Havre
Montivilliers, 76290, France
CHU de Montpellier
Montpellier, 34295, France
CH Morlaix
Morlaix, 29672, France
CHU de Nice
Nice, 06000, France
AP-HP La Pitié-Salpétrière
Paris, 75013, France
AP-HP Cochin
Paris, 75014, France
AP-HP Bichat
Paris, 75018, France
Hopital NOVO - Site Pontoise
Pontoise, 95300, France
CHU Saint-Etienne
Saint-Priest-en-Jarez, 42270, France
CHU Strasbourg
Strasbourg, 67098, France
Clinique Ambroise Paré-Toulouse
Toulouse, 31000, France
CHU de Toulouse
Toulouse, 31059, France
CHU de Tours
Tours, 37044, France
Biospecimen
At inclusion, patients will benefit from blood testing for biobank establishment, and stool sample collection for gut microbiota analysis will be organized depending on the center. The 12-month visit (M12) will also include an additional blood sample collection as part of the biobank, as well as stool sample collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2025
First Posted
August 20, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2034
Last Updated
August 20, 2025
Record last verified: 2025-08