CPPD - Calcium Pyrophosphate Deposition DiseaseORIENTINGNCT07504146
The Orienting Study
An observational study of CPPD - Calcium Pyrophosphate Deposition Disease and Gout, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CPPD - Calcium Pyrophosphate Deposition Disease, Gout
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2024to 30 Oct 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients affected by gout, CPPD or osteoarthritis.
The inclusion criteria for CPPD patients are:
- Patients diagnosed with CPPD disease according to the ACR/EULAR 2023 classification criteria.
- Patients with evidence of asymptomatic CPPD on US or X-rays (not meeting the classification criteria) according to validated imaging definitions.
- Aged older than 18 years.
- Able to provide informed consent, according to requirements of local IRB/ethics committee.
The inclusion criteria for gout patients are:
- Patients diagnosed with gout according to the ACR/EULAR 2015 classification criteria.
- Aged older than 18 years.
- Able to provide informed consent, according to requirements of local IRB/ethics committee.
The inclusion criteria for disease controls are:
- A diagnosis of OA according to ACR classification criteria
- No evidence of uric acid or calcium pyrophosphate deposits on US
- Uric acid < 6 mg/dL
- Aged older than 18 years.
- Able to provide informed consent, according to requirements of local IRB/ethics committee
The exclusion criteria for gout/CPPD patients are:
- Known history of other inflammatory arthropathies
- Unable to provide informed consent, according to requirements of local IRB/ethics committee.
The exclusion criteria for disease controls are:
- Known history of other inflammatory arthropathies
- Unable to provide informed consent, according to requirements of local IRB/ethics committee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milano, 20157
Alessandro Lucia, portaminchiesa@gmail.com
About this study
Official title: The Natural History Of Calcium Pyrophosphate Deposition And Gout: An Observational Clinical And Imaging Study - The Orienting Study
This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.
Read the detailed description
This is a monocentric observational longitudinal study in which patients diagnosed with gout or CPPD and disease-controls with OA will be consecutively recruited from the outpatient clinics of the Rheumatology and Orthopaedic Hip Departments of the IRCCS Galeazzi - Sant'Ambrogio Hospital.
The investigators will enroll consecutive patients with CPPD and gout and disease-controls with OA fulfilling the inclusion and exclusion criteria, from the outpatient clinics of the Rheumatology Department and Orthopaedic Hip Department of the IRCCS Galeazzi - Sant'Ambrogio Hospital, who will be seen for routine or urgent gout/CPPD/OA care following local scheduling processes, without applying any further selection criteria. All patients, in line with clinical routine practice, will undergo a standard clinical, laboratory and imaging assessment, both at baseline and during scheduled follow-up visits (every 6 months) and urgent follow-up visits, tailored to each patient's needs. The study comprises two phases. The first, aims to evaluate the extent of crystal deposition in joints and in blood vessels in patients with CPPD and gout. The second, focuses on monitoring the extension of crystals deposits, their associations with conventional therapies, and evaluating the development of cardiovascular complications in patients with CPPD and gout in comparison to disease-controls with OA. The data for the study will be retrieved from the medical records of the patients and recorded into an appositely created electronic case report form (CRF). The enrollment period will last 3 years (starting from the time of approval of the study), and the follow up period will last 10 years.
- Keywords
- CPPD, Gout, Osteoarthritis, Ultrasound
- Medical subject headings
- Chondrocalcinosis, Gout, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gout | Patients affected by gout according to ACR/EULAR classification criteria | |
| CPPD | Patients affected by gout according to ACR/EULAR classification criteria | |
| Disease control | Patients with a diagnosis of osteoarthritis according to ACR classification criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of CPP crystal deposition assessed by ultrasound over time
Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for CPPD at patient level and at joint level. Each anatomical site will be graded on a semi-quantitative scale from 0 to 3. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time.
Measured: Baseline and every 6 months up to 10 years
Extent of MSU crystal deposition assessed by ultrasound over time
Assessment of the extent of monosodium urate (MSU) crystal deposition Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for Gout Lesions (double contour sign, tophi, aggregates). Each lesion will be graded on a semi-quantitative scale from 0 to 3. A total score will be calculated by summing scores across all evaluated joints. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time.
Measured: Baseline and every 6 months up to 10 years
Progression of bone erosions assessed by ultrasound
Bone erosions will be assessed using the OMERACT Ultrasound Scoring System for Bone Erosions. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total erosion score. The measure will be assessed longitudinally to evaluate changes over time.
Measured: Baseline and every 6 months up to 10 years
Progression of osteophites assessed by ultrasound
Osteophytes will be assessed using the OMERACT Ultrasound Scoring System for Osteophytes. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total osteophyte score. The measure will be assessed longitudinally to evaluate changes over time.
Measured: Baseline and every 6 months up to 10 years
Secondary outcomes (15)
ESR
Change From Baseline in Erythrocyte Sedimentation Rate (ESR mm/h) between patients with CPPD and gout and disease-controls with OA
Measured: From baseline every 6 months up to 10 years
CRP
Change From Baseline in C-Reactive Protein (CRP mg/L) between CPPD and Gout patients and controls with OA
Measured: From baseline every 6 months up to ten years
Synovitis Score Assessed by Global OMERACT-EULAR Synovitis Score (GLOESS)
Synovitis will be evaluated thanks to Global OMERACT-EULAR Synovitis Score (GLOESS). Ultrasound evaluation will be performed on clinically relevant joints and anatomical structures as determined by the treating physician.
Measured: Baseline and every 6 months up to 10 years
Tenosynovitis Score Assessed by OMERACT Ultrasound Scoring System
Tenosynovitis will be assessed using the OMERACT ultrasound scoring system on a semi-quantitative scale. Ultrasound evaluation will be performed on clinically relevant joints and anatomical structures as determined by the treating physician.
Measured: Baseline and every 6 months up to 10 years
Joint Effusion Score Assessed by Ultrasound
Joint effusion will be assessed using ultrasound on a semi-quantitative scale from 0 to 3. The joints to be evaluated will be selected according to the clinician's judgement
Measured: Baseline and every 6 months up to 10 years
Number of Tender Joints Assessed Using 68-Joint Count
The number of tender joints will be assessed using the 68-joint count method.
Measured: Baseline and every 6 months up to 10 years
Number of Swollen Joints Assessed Using 66-Joint Count
The number of swollen joints will be assessed using the 66-joint count method.
Measured: Baseline and every 6 months up to 10 years
Physician Global Assessment of Disease Activity
Disease activity will be assessed by the physician using a visual analog scale (0-100)
Measured: Baseline and every 6 months up to 10 years
Patient Global Assessment of Disease Activity
Scale (0-100)
Measured: Baseline and every 6 months up to 10 years
Patient-Reported Pain Assessed by Visual Analog Scale (VAS)
Scale (0-100)
Measured: Baseline and every 6 months up to 10 years
Patient-Reported Global Health Status
Scale (0-100)
Measured: Baseline and every 6 months up to 10 years
Functional Disability Assessed by Health Assessment Questionnaire (HAQ)
Score (0-3) for every item of the questionnaire, then the sum is calculated
Measured: From baseline every six months up to ten years
Cardiovascular Risk Assessed by SCORE2 and SCORE2-OP
Cardiovascular risk will be estimated using SCORE2 and SCORE2-OP algorithms, depending on patient's age. Both scores express a percentage (%) of the 10-year risk.
Measured: At baseline and if clinically indicated during follow-up up to ten years
Incidence of Cardiovascular Events
Occurrence of cardiovascular events recorded during follow-up (Number of events / % of patients)
Measured: During the 10 years follow up
Distribution of Clinical Phenotypes of CPPD and Gout
Phenotypes of calcium pyrophosphate deposition (CPPD) disease and gout will be classified according to established classification criteria (ACR/EULAR recommendations and G-CAN consensus respectively).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start30 Oct 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for CPPD - Calcium Pyrophosphate Deposition DiseaseStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgios Filippou, MD, Principal investigator, Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504146
- Sponsor's protocol ID
- ORIENTING L4181
- Acronym
- ORIENTING
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moller I, Janta I, Backhaus M, Ohrndorf S, Bong DA, Martinoli C, Filippucci E, Sconfienza LM, Terslev L, Damjanov N, Hammer HB, Sudol-Szopinska I, Grassi W, Balint P, Bruyn GAW, D'Agostino MA, Hollander D, Siddle HJ, Supp G, Schmidt WA, Iagnocco A, Koski J, Kane D, Fodor D, Bruns A, Mandl P, Kaeley GS, Micu M, Ho C, Vlad V, Chavez-Lopez M, Filippou G, Ceron CE, Nestorova R, Quintero M, Wakefield R, Carmona L, Naredo E. The 2017 EULAR standardised procedures for ultrasound imaging in rheumatology. Ann Rheum Dis. 2017 Dec;76(12):1974-1979. doi: 10.1136/annrheumdis-2017-211585. Epub 2017 Aug 16.
PubMed 28814430Hammer HB, Iagnocco A, Mathiessen A, Filippucci E, Gandjbakhch F, Kortekaas MC, Moller I, Naredo E, Wakefield RJ, Aegerter P, D'Agostino MA. Global ultrasound assessment of structural lesions in osteoarthritis: a reliability study by the OMERACT ultrasonography group on scoring cartilage and osteophytes in finger joints. Ann Rheum Dis. 2016 Feb;75(2):402-7. doi: 10.1136/annrheumdis-2014-206289. Epub 2014 Dec 17.
PubMed 25520476Naredo E, D'Agostino MA, Wakefield RJ, Moller I, Balint PV, Filippucci E, Iagnocco A, Karim Z, Terslev L, Bong DA, Garrido J, Martinez-Hernandez D, Bruyn GA; OMERACT Ultrasound Task Force*. Reliability of a consensus-based ultrasound score for tenosynovitis in rheumatoid arthritis. Ann Rheum Dis. 2013 Aug;72(8):1328-34. doi: 10.1136/annrheumdis-2012-202092. Epub 2012 Sep 14.
PubMed 22984169Horta-Baas G. Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake? Patient Relat Outcome Meas. 2022 Mar 30;13:79-95. doi: 10.2147/PROM.S256715. eCollection 2022.
PubMed 35388274Duarte-Garcia A, Leung YY, Coates LC, Beaton D, Christensen R, Craig ET, de Wit M, Eder L, Fallon L, FitzGerald O, Gladman DD, Goel N, Holland R, Lindsay C, Maxwell L, Mease P, Orbai AM, Shea B, Strand V, Veale DJ, Tillett W, Ogdie A. Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report. J Rheumatol. 2019 Aug;46(8):996-1005. doi: 10.3899/jrheum.181089. Epub 2019 Feb 15.
PubMed 30770518Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10. doi: 10.1002/art.1780331101.
PubMed 2242058Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.
PubMed 2025304Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
PubMed 3741515Sirotti S, Becce F, Sconfienza LM, Terslev L, Naredo E, Zufferey P, Pineda C, Gutierrez M, Adinolfi A, Serban T, MacCarter D, Mouterde G, Zanetti A, Scanu A, Moller I, Novo-Rivas U, Largo R, Sarzi-Puttini P, Abhishek A, Choi HK, Dalbeth N, Pascart T, Tedeschi SK, D'Agostino MA, Iagnocco A, Keen HI, Scire CA, Filippou G. Reliability and Diagnostic Accuracy of Radiography for the Diagnosis of Calcium Pyrophosphate Deposition: Performance of the Novel Definitions Developed by an International Multidisciplinary Working Group. Arthritis Rheumatol. 2023 Apr;75(4):630-638. doi: 10.1002/art.42368. Epub 2023 Jan 19.
PubMed 36122187Abhishek A, Tedeschi SK, Pascart T, Latourte A, Dalbeth N, Neogi T, Fuller A, Rosenthal A, Becce F, Bardin T, Ea HK, Filippou G, Fitzgerald J, Iagnocco A, Liote F, McCarthy GM, Ramonda R, Richette P, Sivera F, Andres M, Cipolletta E, Doherty M, Pascual E, Perez-Ruiz F, So A, Jansen TL, Kohler MJ, Stamp LK, Yinh J, Adinolfi A, Arad U, Aung T, Benillouche E, Bortoluzzi A, Dau J, Maningding E, Fang MA, Figus FA, Filippucci E, Haslett J, Janssen M, Kaldas M, Kimoto M, Leamy K, Navarro GM, Sarzi-Puttini P, Scire C, Silvagni E, Sirotti S, Stack JR, Truong L, Xie C, Yokose C, Hendry AM, Terkeltaub R, Taylor WJ, Choi HK. The 2023 ACR/EULAR classification criteria for calcium pyrophosphate deposition disease. Ann Rheum Dis. 2023 Oct;82(10):1248-1257. doi: 10.1136/ard-2023-224575. Epub 2023 Jul 26.
PubMed 37495237SCORE2-OP working group and ESC Cardiovascular risk collaboration. SCORE2-OP risk prediction algorithms: estimating incident cardiovascular event risk in older persons in four geographical risk regions. Eur Heart J. 2021 Jul 1;42(25):2455-2467. doi: 10.1093/eurheartj/ehab312.
PubMed 34120185SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.
PubMed 34120177Wang Y, Deng X, Zhang X, Geng Y, Ji L, Song Z, Zhang Z. Presence of tophi and carotid plaque were risk factors of MACE in subclinical artherosclerosis patients with gout: a longitudinal cohort study. Front Immunol. 2023 Apr 18;14:1151782. doi: 10.3389/fimmu.2023.1151782. eCollection 2023.
PubMed 37143665Dalbeth N, Gosling AL, Gaffo A, Abhishek A. Gout. Lancet. 2021 May 15;397(10287):1843-1855. doi: 10.1016/S0140-6736(21)00569-9. Epub 2021 Mar 30.
PubMed 33798500Bashir M, Sherman KA, Solomon DH, Rosenthal A, Tedeschi SK. Cardiovascular Disease Risk in Calcium Pyrophosphate Deposition Disease: A Nationwide Study of Veterans. Arthritis Care Res (Hoboken). 2023 Feb;75(2):277-282. doi: 10.1002/acr.24783. Epub 2022 Oct 11.
PubMed 34523251
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History Of Calcium Pyrophosphate Deposition And Gout: An Observational Clinical And Imaging Study - The Orienting Study
- ClinicalTrials.gov ID
- NCT07504146
- Acronym / sponsor ID
- ORIENTING / ORIENTING L4181
- Keywords
- CPPD, Gout, Osteoarthritis, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2039 (estimated)
- First posted
- 31 Mar 2026 (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.
This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.
Detailed description
This is a monocentric observational longitudinal study in which patients diagnosed with gout or CPPD and disease-controls with OA will be consecutively recruited from the outpatient clinics of the Rheumatology and Orthopaedic Hip Departments of the IRCCS Galeazzi - Sant'Ambrogio Hospital.
The investigators will enroll consecutive patients with CPPD and gout and disease-controls with OA fulfilling the inclusion and exclusion criteria, from the outpatient clinics of the Rheumatology Department and Orthopaedic Hip Department of the IRCCS Galeazzi - Sant'Ambrogio Hospital, who will be seen for routine or urgent gout/CPPD/OA care following local scheduling processes, without applying any further selection criteria. All patients, in line with clinical routine practice, will undergo a standard clinical, laboratory and imaging assessment, both at baseline and during scheduled follow-up visits (every 6 months) and urgent follow-up visits, tailored to each patient's needs. The study comprises two phases. The first, aims to evaluate the extent of crystal deposition in joints and in blood vessels in patients with CPPD and gout. The second, focuses on monitoring the extension of crystals deposits, their associations with conventional therapies, and evaluating the development of cardiovascular complications in patients with CPPD and gout in comparison to disease-controls with OA. The data for the study will be retrieved from the medical records of the patients and recorded into an appositely created electronic case report form (CRF). The enrollment period will last 3 years (starting from the time of approval of the study), and the follow up period will last 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gout | – | –Patients affected by gout according to ACR/EULAR classification criteria |
| CPPD | – | –Patients affected by gout according to ACR/EULAR classification criteria |
| Disease control | – | –Patients with a diagnosis of osteoarthritis according to ACR classification criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by gout, CPPD or osteoarthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extent of CPP crystal deposition assessed by ultrasound over time
Time frame: Baseline and every 6 months up to 10 years
Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for CPPD at patient level and at joint level. Each anatomical site will be graded on a semi-quantitative scale from 0 to 3. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time.
Extent of MSU crystal deposition assessed by ultrasound over time
Time frame: Baseline and every 6 months up to 10 years
Assessment of the extent of monosodium urate (MSU) crystal deposition Calcium pyrophosphate crystal deposition (CPPD) will be assessed using the OMERACT Ultrasound Scoring System for Gout Lesions (double contour sign, tophi, aggregates). Each lesion will be graded on a semi-quantitative scale from 0 to 3. A total score will be calculated by summing scores across all evaluated joints. According to the clinical scenario and the clinician decision, patients will undergo an US examination of the affected joints. Case by case the following joints will be evaluated: shoulder, elbow, wrist, hand, hip, knee, ankle, Achilles tendon, foot. The total score will be calculated as the sum of scores across all evaluated sites and normalized by the number of sites assessed per patient. The measure will be assessed longitudinally to evaluate changes in crystal deposition over time.
Progression of bone erosions assessed by ultrasound
Time frame: Baseline and every 6 months up to 10 years
Bone erosions will be assessed using the OMERACT Ultrasound Scoring System for Bone Erosions. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total erosion score. The measure will be assessed longitudinally to evaluate changes over time.
Progression of osteophites assessed by ultrasound
Time frame: Baseline and every 6 months up to 10 years
Osteophytes will be assessed using the OMERACT Ultrasound Scoring System for Osteophytes. Each site will be graded from 0 to 3 and summed across all evaluated joints to obtain a total osteophyte score. The measure will be assessed longitudinally to evaluate changes over time.
15 secondary outcomes
ESR
Time frame: From baseline every 6 months up to 10 years
CRP
Time frame: From baseline every 6 months up to ten years
Synovitis Score Assessed by Global OMERACT-EULAR Synovitis Score (GLOESS)
Time frame: Baseline and every 6 months up to 10 years
Tenosynovitis Score Assessed by OMERACT Ultrasound Scoring System
Time frame: Baseline and every 6 months up to 10 years
Joint Effusion Score Assessed by Ultrasound
Time frame: Baseline and every 6 months up to 10 years
Number of Tender Joints Assessed Using 68-Joint Count
Time frame: Baseline and every 6 months up to 10 years
Number of Swollen Joints Assessed Using 66-Joint Count
Time frame: Baseline and every 6 months up to 10 years
Physician Global Assessment of Disease Activity
Time frame: Baseline and every 6 months up to 10 years
Patient Global Assessment of Disease Activity
Time frame: Baseline and every 6 months up to 10 years
Patient-Reported Pain Assessed by Visual Analog Scale (VAS)
Time frame: Baseline and every 6 months up to 10 years
Patient-Reported Global Health Status
Time frame: Baseline and every 6 months up to 10 years
Functional Disability Assessed by Health Assessment Questionnaire (HAQ)
Time frame: From baseline every six months up to ten years
Cardiovascular Risk Assessed by SCORE2 and SCORE2-OP
Time frame: At baseline and if clinically indicated during follow-up up to ten years
Incidence of Cardiovascular Events
Time frame: During the 10 years follow up
Distribution of Clinical Phenotypes of CPPD and Gout
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 28814430Moller I, Janta I, Backhaus M, Ohrndorf S, Bong DA, Martinoli C, Filippucci E, Sconfienza LM, Terslev L, Damjanov N, Hammer HB, Sudol-Szopinska I, Grassi W, Balint P, Bruyn GAW, D'Agostino MA, Hollander D, Siddle HJ, Supp G, Schmidt WA, Iagnocco A, Koski J, Kane D, Fodor D, Bruns A, Mandl P, Kaeley GS, Micu M, Ho C, Vlad V, Chavez-Lopez M, Filippou G, Ceron CE, Nestorova R, Quintero M, Wakefield R, Carmona L, Naredo E. The 2017 EULAR standardised procedures for ultrasound imaging in rheumatology. Ann Rheum Dis. 2017 Dec;76(12):1974-1979. doi: 10.1136/annrheumdis-2017-211585. Epub 2017 Aug 16.
- Background: PubMed 25520476Hammer HB, Iagnocco A, Mathiessen A, Filippucci E, Gandjbakhch F, Kortekaas MC, Moller I, Naredo E, Wakefield RJ, Aegerter P, D'Agostino MA. Global ultrasound assessment of structural lesions in osteoarthritis: a reliability study by the OMERACT ultrasonography group on scoring cartilage and osteophytes in finger joints. Ann Rheum Dis. 2016 Feb;75(2):402-7. doi: 10.1136/annrheumdis-2014-206289. Epub 2014 Dec 17.
- Background: PubMed 22984169Naredo E, D'Agostino MA, Wakefield RJ, Moller I, Balint PV, Filippucci E, Iagnocco A, Karim Z, Terslev L, Bong DA, Garrido J, Martinez-Hernandez D, Bruyn GA; OMERACT Ultrasound Task Force*. Reliability of a consensus-based ultrasound score for tenosynovitis in rheumatoid arthritis. Ann Rheum Dis. 2013 Aug;72(8):1328-34. doi: 10.1136/annrheumdis-2012-202092. Epub 2012 Sep 14.
- Background: PubMed 35388274Horta-Baas G. Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake? Patient Relat Outcome Meas. 2022 Mar 30;13:79-95. doi: 10.2147/PROM.S256715. eCollection 2022.
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- Individual participant dataSharing planned: Undecided
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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.
Georgios Filippou, MD principal investigator
Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio
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 CPPD - Calcium Pyrophosphate Deposition Disease and Gout, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 31 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Filippou, MD (0039 0283502707, georgios.filippou@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of CPP crystal deposition assessed by ultrasound over time (time frame: Baseline and every 6 months up to 10 years). The study lists 4 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 NCT07504146, which also lists 18 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 31 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.