Pilot Study of Ultrasound in Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Musculoskeletal Ultrasound; Other: Semi-structured patient interview

• Registration Number: NCT02064400
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational study group	Musculoskeletal Ultrasound	Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)
Observational study group	Semi-structured patient interview	Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)

Primary Outcome Measures

Name	Time	Method
Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score	At recruitment	Defined as Kappa statistic of at least 0.4.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle upon Tyne, United Kingdom