Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

Study Overview
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Brief Summary
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Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients classified in remission/low disease activity in terms of Patient Reported Outcomes.

Official Title
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The Impact of Musculoskeletal Ultrasound-added to Clinical Evaluations- on Patient Reported Outcomes: A Prospective Study of Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity (ULTRAPRO)

Conditions
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Rheumatoid Arthritis, Patient Reported Outcomes, Musculoskeletal Ultrasound

Intervention / Treatment
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* Diagnostic Test: MusculoSkeletal Ultrasound
* Diagnostic Test: MusculoSkeletal Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical diagnosis of RA made at the discretion of the attending experienced rheumatologist. Patients classified in remission/low disease activity Exclusion Criteria: <16 years old. Patient with recent trauma in the evaluated joints. Luxation in the MCP, PIP or MTP joints.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound shared<br>Patient will be assessed with ultrasound (GUS-7 score) | Diagnostic Test: MusculoSkeletal Ultrasound<br>* Patient will be assess with ultrasound (GUS-7 score) and the results will be informed to his/her attending Rheumatologist. The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.<br>|
| Experimental: Ultrasound not shared<br>Patient will be assessed with ultrasound (GUS-7 score) | Diagnostic Test: MusculoSkeletal Ultrasound<br>* Patient will be assess with ultrasound (GUS-7 score) and the results will not be informed to his/her attending Rheumatologist. The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of the Patient Reported Outcome (HAQ) | Minimal Clinically Significant change in HAQ | From baseline at 6 months | 
| Change from Baseline of the Patient Reported Outcome (RADAI) | Minimal Clinically Significant change in RADAI | from baseline at 6 months | 
| Change from Baseline of the Patient Reported Outcome (SF-36) | Minimal Clinically Significant change in SF-36 | from baseline at 6 months | 
| Change from Baseline of the Patient Reported Outcome (VAS-Patient) | Minimal Clinically Significant change in VAS-Patient | from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity | Describe ultrasound findings at the moment of inclusion in the study. | Baseline | 
| Clinical relapse: Proportion of patients with relapse after the intervention in both groups | Describe the proportion of patients with relapse after the intervention in both groups. | baseline and 6 months | 
| Change from Baseline of the Patient Reported Outcome (HAQ) | Minimal Clinically Significant change in HAQ | from baseline at 12 months | 
| Change from Baseline of the Patient Reported Outcome (RADAI) | Minimal Clinically Significant change in RADAI | from baseline at 12 months | 
| Change from Baseline of the Patient Reported Outcome (SF-36) | Minimal Clinically Significant change in SF-36 | from baseline at 12 months | 
| Change from Baseline of the Patient Reported Outcome (VAS-Patient) | Minimal Clinically Significant change in VAS-Patient | from baseline at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Ultrasound, Impact