Polymyalgia RheumaticaJADORENCT07132164
Justification of the Initial Diagnosis and Evaluation of the Overall Evolution of a Cohort of Recent Polymyalgia Rheumatica (JADORE)
An observational study of Polymyalgia Rheumatica and Inflammatory Rheumatism, run by University Hospital, Brest at 30 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica, Inflammatory Rheumatism
- What is being tested?
- biobank sample collection
- How many people
- 400 participants
- Where
- 30 sitesFrance
- Study dates
- 1 Jul 2026to 1 Jul 2035
- Phase
- Observational
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Presence, at the time of diagnosis, of symptoms and/or signs suggesting a diagnosis of associated giant cell arteritis
- Immuno-induced PPR
- Patients receiving immunosuppressive treatment with methotrexate or immunotherapy targeting interleukin-6 at inclusion.
- 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
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- Patients unable to consent or unable or unwilling to complete their corticosteroid dose monitoring record.
- Pregnancy
- Patients under guardianship, curatorship or safeguard of justice
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites
Besançon-CIC
Besançon, 25000
Eric TOUSSIROT, Pr, etoussirot@chu-besancon.fr
CHU Besançon
Besançon, 25030
Daniel WENDLING, Pr, dwendling@chu-besancon.fr
CHU de Bordeaux Pellegrin
Bordeaux, 33076
Marie-Elise TRUCHETET, Pr, marie-elise.truchetet@chu-bordeaux.fr
CH Boulogne/mer
Boulogne-sur-Mer, 62321
Renaud DESBARBIEUX, r.desbarbieux@ch-boulogne.fr
CHU de Brest
Brest, 29609
Valérie DEVAUCHELLE, Pr, 0298347264, valerie.devauchelle-pensec@chu-brest.fr
Valérie DEVAUCHELLE, Pr
CHU de Caen
Caen, 14033
Anne-Christine RAT, rat-ac@chu-caen.fr
Clinique de l'Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300
BASCH, Dr, andcroco@gmail.com
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Anne TOURNADRE, Pr, atournadre@chu-clermontferrand.fr
CH Dax
Dax, 40107
Emilie SHIPLEY, Dr, shipleye@ch-dax.fr
CHU de Dijon
Dijon, 21000
André RAMON, Pr, andre.ramon@chu-dijon.fr
CH La Roche s/ Yon
La Roche-sur-Yon, 85925
CORMIER, Dr, gregoire.cormier@ght85.fr
APHP - Kremlin-Bicêtre
Le Kremlin-Bicêtre, 94270
SEROR, Pr, raphaele.seror@aphp.fr
CH Le Mans
Le Mans, 72037
Emmanuelle DERNIS, Dr, edernis@ch-lemans.fr
CHU de Lille
Lille, 59037
Bernard CORTET, Pr, Bernard.CORTET@chu-lille.fr
Institut catholique de Lille
Lomme, 59160
PACAUD, Dr, pacaud.aurore@ghicl.net
CHU Marseille AP-HM
Marseille, 13009
Thao PHAM, Pr, Thao.PHAM@ap-hm.fr
CH Le Havre
Montivilliers, 76290
BREVET, Dr, pauline.brevet@ch-havre.fr
CHU de Montpellier
Montpellier, 34295
Jacques MOREL, Pr, j-morel@chu-montpellier.fr
CH Morlaix
Morlaix, 29672
Catherine LE HENAFF, CLehenaff@ch-morlaix.fr
CHU de Nice
Nice, 06000
Christian ROUX, Pr, roux.c2@chu-nice.fr
AP-HP La Pitié-Salpétrière
Paris, 75013
Bruno FAUTREL, Pr, bruno.fautrel@aphp.fr
AP-HP Cochin
Paris, 75014
FOGEL, Dr, olivier.fogel@aphp.fr
AP-HP Bichat
Paris, 75018
Philippe DIEUDE, Pr, philippe.dieude@aphp.fr
Hopital NOVO - Site Pontoise
Pontoise, 95300
AL TABAA, Dr, omar.altabaa@ght-novo.fr
CHU Rouen
Rouen, Rouen, 76038
GÉRARD, Dr, 02.32.88.90.19, baptiste.gerard@chu-rouen.fr
CHU Saint-Etienne
Saint-Priest-en-Jarez, 42270
MAROTTE, Pr, hubert.marotte@chu-st-etienne.fr
CHU Strasbourg
Strasbourg, 67098
Jacques-Eric GOTTENBERG, Pr, jacques-eric.gottenberg@chru-strasbourg.fr
Clinique Ambroise Paré-Toulouse
Toulouse, 31000
Martin MICHAUD, Pr, m.michaud@clinique-ambroise-pare.fr
CHU de Toulouse
Toulouse, 31059
Adeline RUYSSEN-WITRAND, Pr, ruyssen-witrand.a@chu-toulouse.fr
CHU de Tours
Tours, 37044
Guillemo CARVAJAL ALEGRIA, Dr, guillermo.carvajal@univ-tours.fr
About this study
Official title: Justification of the Initial Diagnosis and Evaluation of the Overall Evolution of a Cohort of Recent Polymyalgia Rheumatica
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.
Read more
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.
Read the detailed description
Participation in the study will be offered to all patients meeting the inclusion and non-inclusion criteria. Patients will be given sufficient time to reflect before confirming their participation in the study (the usual delay in obtaining the results of the initial pathology assessment before starting prolonged corticosteroid therapy means that this delay will in practice be several days in all cases). All study assessments will be carried out at visits corresponding to these patients' routine care (M0 inclusion), M3, M6, M12, M24, M36, M48 and M60. Two additional teleconsultation visits at M18 and M30 may be carried out to record major follow-up events (current treatments and dose, disease activity, treatment complications, occurrence of ACG). Patients will also be assessed at the time of their first relapse, if applicable.
At the inclusion visit, data will be collected on the complementary examinations usually carried out as part of the initial PPR work-up: standard biological work-up, immune work-up, chest X-ray, shoulder and pelvis X-rays, and bone densitometry. Data concerning the performance of a PET scan or MRI of the shoulders will also be collected. Patients will have a blood test to build up the biocollection, and a stool sample (depending on the center) will be collected to study intestinal microbiota. Patients will receive ultrasound scans of the hips and shoulders as part of their routine care. Doppler ultrasound of the supra-aortic trunks will be performed (at extra cost). Quality-of-life questionnaires will be completed. Sarcopenia will be assessed using the SARC-F self-questionnaire, SPPB muscle performance measurement, Handgrip test muscle strength and frailty syndrome.
Patients for whom the clinician's conviction is less than 50% after the initial complementary assessment will not be followed up in the cohort. At one year's follow-up, if the clinician's conviction remains > 50%, patients will be followed up in the study. For the others, follow-up will be stopped.
Follow-up visits and the additional visit at the time of the first relapse will include the collection of clinical, biological and imaging data corresponding to routine care, as well as the administration of quality-of-life questionnaires. The visit at M12 will also include additional blood collection as part of the biocollection and the collection of a stool sample.
Throughout the study, the daily and cumulative dosage of glucocorticoids and immunosuppressants actually received by patients will be collected via a paper logbook or a dedicated application (internet/redcap or Smartphone).
- Conditions
- Polymyalgia Rheumatica, Inflammatory Rheumatism
- Being tested
- biobank sample collection
- Keywords
- polymyalgia Rheumatica
- Medical subject headings
- Polymyalgia Rheumatica, Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biobank sample collectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Biological sample collection | Biobank establishment and stool sample collection for gut microbiota analysis Receives: Other: biobank sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of DAS-PPR (Disease Activity Score)
Measured: 12 months
Number of participants with no PPR-related treatment for at least 2 weeks
Measured: 12 months
Secondary outcomes (33)
Number of patients with a Diagnosis of PPR maintained
Medical reassessment of patients for diagnostic reassessment
Measured: 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
Measured: Inclusion
Shoulder and hip ultrasound score
Measured: Inclusion
Measurement of the Leuven score
Measured: Inclusion
Definitive diagnosis of PRA according to the expert clinican
Measured: Month 24
Characteristics of clinical PRA (collection of affected joints)
Measured: Inclusion
Characteristics of clinical PRA (CRP level)
Measured: Inclusion
Alternative diagnosis retained by the expert clinician: microcrystalline inflammatory rheumatism; other chronic inflammatory rheumatic diseases ; paraneoplastic rheumatism
Measured: Inclusion, Month 12, 24, 36, 48 and 60
Measurement of DAS-PPR (Disease Activity Score)
Measured: Inclusion, Month 3, 6, 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
Remission: DAS-PPR < 10, no corticosteroids, and no immunomodulatory treatments
Measured: Inclusion, Month 3, 6, 12, 24, 36, 48, 60
Relapse: Reinitiation of corticosteroids or immunomodulatory therapy
Measured: Inclusion, Month 3, 6, 12, 24, 36, 48, 60
Number of patient with a Diagnosis of Giant Cell Arthritis during the follow-up of the study
Measured: Month 3, 6, 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
Measurement of SF36
Measured: Inclusion, Month 3, 6, 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
Measurement of EQ-5D
Measured: Inclusion, Month 3, 6, 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
Death occurence
Measured: Month 3, 6, 12, 24, 36, 48, 60
Adverse events characteristic of PPR
Measured: Month 3, 6, 12, 24, 36, 48, 60, First Relapse within 5 years of follow-up
Dosage of glucocorticoids
Measured: Inclusion, Month 3, 6, 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
Measurement of Glucocorticoid toxicity with the Glucocorticoid toxicity index, gti score
Measured: Inclusion, Month 3, 6, 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
Change in lipid parameters
Measured: Inclusion, Month 12
Change in glycemic parameters
Measured: Inclusion, Month 12
Measurement of bone densitometry parameters
Measured: Inclusion, Month 12
Number of Fracture event
Measured: Month 3, 6, 12, 24, 36, 48, 60
Number of falls self-reported by patients
Measured: Month 12, 24, 26, 48, 60
Cumulative dose of corticosteroids received by the patient since inclusion
Measured: Month 12, 24, 36, 48, 60
Relapse rate after stopping immunomodulators
Measured: Month 3, 6, 12, 24, 36, 48, 60, First relapse within 5 years of follow-up
SARC-F self-questionnaire
Measured: Inclusion, M12, M36, M60, First relapse within 5 years of follow-up
Handgrip measure with handgrip test
Measured: Inclusion, M12, M36, M60, First relapse within 5 years of follow-up
Short Physical Performance Battery
Measured: Inclusion, M12, M36, M60, First relapse within 5 years of follow-up
Occurence of Gastrointestinal perforations
Measured: Inclusion, M12, M36, M60, First relapse within 5 years of follow-up
Major adverse cardiovascular events
Measured: Inclusion, M12, M36, M60, First relapse within 5 years of follow-up
Measuring the Groll index
Measured: Inclusion, Month 6, 12, 24, 36, 48, 60
Measurement of the Fragility Score (FRIED)
Measured: Inclusion, Month 12, 36, 60, First relapse within 5 years of follow-up
Serum and transcriptomic biomarkers
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132164
- Sponsor's protocol ID
- 29BRC21.0391
- Other IDs
- 2024-A00863-44
- Acronym
- JADORE
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided