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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones, joint capsule, tendons and ligaments leading to the consequential functional joint deterioration.
The main goal of RA treatment is to achieve disease remission. The treatment of RA consists of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected when low disease or remission is not achieved with the first ones. Therapeutic response monitoring in RA should be closely managed. It is classically based on clinical exploration and laboratory tests. During the last decade, the resolution improvement of musculoskeletal ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the evaluation and monitoring of patients with RA, mainly due to its better capacity to detect synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive, reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects pathological synovial flow, which reflects synovial inflammation and has a demonstrated sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by ultrasound. There has been high variability in the literature regarding the number of joints that should be evaluated for an appropriate monitoring of the RA patients. The validity for monitoring the therapeutic response in long standing RA has been demonstrated in three reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the sensitivity to change of any of these reduced ultrasound evaluations has never been studied
Primary objectives
• To evaluate the sensitivity to change of the Doppler Ultrasound evaluation of 12, 7 and 6 joints counts in RA patients with more than 6 months and less than 5 years of evolution, which initiate an effective treatment for the disease according to indication (biologic DMARD in monotherapy or combined with methotrexate).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis(RA) patients | The patients will be evaluated according to clinical practice (clinical evaluation and inflammation markers) at baseline and 3 and 6 months after the initiation of the treatment with the biologic DMARD. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mode B and power Doppler (PD) ultrasound evaluation | Mode B and PD ultrasound evaluation will consist in quantifying the synovitis (0 to 3) in B mode (synovial hypertrophy, effusion) and PD with quantification system OMERACT (Outcome Measures in Rheumatology) in the following bilateral joints:
| at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD |
| Measure | Description | Time Frame |
|---|---|---|
| Dopler Ultrasound sensitivity to change comparison | at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatoid arthritis patients with more than 6 months and less than 5 years of active evolution (DAS28 > 3.2 or SDAI > 11) and which start treatment with biologic therapy for the first time independently of the combination with synthetic DMARDs. The patients will be evaluated according to clinical practice (clinical evaluation and inflammation markers) at baseline and 3 and 6 months after the initiation of the treatment with the biologic DMARD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ESPERANZA NAREDO, PhD | Contact | enaredo@ser.es | ||
| Juan Carlos Nieto, MD | Contact | juancarlos.nietog@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ESPERANZA NAREDO, PhD | Hospital General Universitario Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopsital general Universitario Gregorio Marañón | Recruiting | Madrid | Madrid | 28007 | Spain |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |