Pilot Study of Ultrasound in Rheumatoid Arthritis

Study Overview
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Brief Summary
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Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made. This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.

Official Title
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A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Musculoskeletal Ultrasound
* Other: Semi-structured patient interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of rheumatoid arthritis with symptom onset at least 12 months previously Current disease-modifying anti-rheumatic drug (DMARD) therapy or biologic therapy Currently stable arthritis defined as no change in DMARD treatment over previous 6 months, and no use of steroids (enteral, parenteral or intra-articular) over previous 6 months Exclusion Criteria: Inability to provide informed consent Current or recent (within 4 months) participation within another clinical trial

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational study group<br>Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients) | Other: Musculoskeletal Ultrasound<br>* 7-joint musculoskeletal ultrasound scan<br>Other: Semi-structured patient interview<br>* Semi-structured patient interview<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score | Defined as Kappa statistic of at least 0.4. | At recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative data relating to patients' views and opinions of their arthritis medication | Based upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques. | At recruitment | 
| Simplified Disease Activity Index (SDAI) |  | At recruitment | 
| Disease Activity Score in 28 joints (DAS-28) |  | At recruitment | 
| Disease Activity Score (DAS) |  | At recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Ultrasound, Remission, Qualitative