Clinical trial NCT02064400: Pilot Study of Ultrasound in Rheumatoid Arthritis
Official title: A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Ultrasound
Remission
Qualitative
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Newcastle University
name: Wellcome Trust
First posted: 2014-02-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care rheumatology outpatient clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score
timeFrame: At recruitment
Secondary outcomes:
measure: Qualitative data relating to patients' views and opinions of their arthritis medication
timeFrame: At recruitment
measure: Simplified Disease Activity Index (SDAI)
timeFrame: At recruitment
measure: Disease Activity Score in 28 joints (DAS-28)
timeFrame: At recruitment
measure: Disease Activity Score (DAS)
timeFrame: At recruitment
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Newcastle University
name: John D Isaacs, PhD, MB BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baker KF, Isaacs JD, Thompson B. "Living a normal life": a qualitative study of patients' views of medication withdrawal in rheumatoid arthritis. BMC Rheumatol. 2019 Jun 13;3:2. doi: 10.1186/s41927-019-0070-y. eCollection 2019.