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Pilot Study of Ultrasound in Rheumatoid Arthritis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02064400
Enrollment
17
Registered
2014-02-17
Start date
2014-02-28
Completion date
2014-07-31
Last updated
2015-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Ultrasound, Remission, Qualitative

Brief summary

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.

Interventions

7-joint musculoskeletal ultrasound scan

OTHERSemi-structured patient interview

Semi-structured patient interview

Sponsors

Newcastle University
CollaboratorOTHER
Wellcome Trust
CollaboratorOTHER
Newcastle-upon-Tyne Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis scoreAt recruitmentDefined as Kappa statistic of at least 0.4.

Secondary

MeasureTime frameDescription
Qualitative data relating to patients' views and opinions of their arthritis medicationAt recruitmentBased upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques.
Simplified Disease Activity Index (SDAI)At recruitment
Disease Activity Score in 28 joints (DAS-28)At recruitment
Disease Activity Score (DAS)At recruitment

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026