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Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score)
Secondary objectives:
Multicenter, prospective, open-label, cohort study with collection of blood samples and ultrasound / MRI and x-ray examination.
Duration of study: 12 months This study is a prospective cohort study. The choice of therapy at any time during the study is entirely up to the treating rheumatologist. The study does not put any restriction on the management of the patient which will be according to routine care.
At occurrence of one or more of the above mentioned variables defining adverse clinical outcome (prednisone in a dose exceeding 10mg/d and/or intraarticular steroid injections and/or start of biologic DMARD) an analysis as for D360 will be performed US-Score: SONAR-Score assessment of synovitis (22 joints)/erosions (14 joints)/cartilage thickness (8 joints) Clinical evaluation: Disease activity score (DAS28 = Number of tender and swollen joints (0-28), additional measures (ESR / CRP), Patient Global Health (0-100), health assessment questionnaire (HAQ) at 0, 3, 6, 9, 12 months (attached) Lab: ESR, CRP Serology: Antinuclear antibody (ANA), Rheumatoid factor (RF), Anti-cyclic citrullinated peptide (anti-CCP) at baseline if not available COL2-1 / COL2-1N X-Ray: hands and feet at baseline and 12 months (scoring according to Ratingen Score) if not available MRI without contrast at baseline and at 12 months or when first erosions detected with US
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort study | Other | Collection of blood samples and ultrasound / MRI and x-ray examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venipuncture, ultrasound, MRI, x-ray | Procedure | Collection of blood samples and ultrasound / MRI and x-ray examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the predictive value of US alone and in combination with cartilage biodegradation markers on radiographic progression (change in Ratingen score) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of ultrasound synovitis score and clinical disease activity score | 12 months | |
| Determination of the sensitivity of ultrasound erosion detection compared to MRI | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrian Ciurea, MD | Contact | +41 44 255 29 58 | adrian.ciurea@usz.ch | |
| Mariusz Wasila, MD | Contact | +41 44 255 29 99 | mariusz.wasila@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Adrian Ciurea, MD | Department of Rheumatology, University Hospital Zurich | Principal Investigator |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| D019220 | High-Energy Shock Waves |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Assessment of the value of including tenosynovitis assessment for predicting radiographic progression |
| 12 months |
| Assessment of the predictive value of ultrasound synovitis score at baseline for the need to install biologic DMARDs | 12 months |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D011839 | Radiation, Ionizing |