Pilot Study of Ultrasound in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064400
• Other study ID #: NUTH6919
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: June 25, 2015
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Musculoskeletal Ultrasound
7-joint musculoskeletal ultrasound scan
• Semi-structured patient interview
Semi-structured patient interview

Locations

Country	Name	City	State
United Kingdom	Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle University, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Simplified Disease Activity Index (SDAI)		At recruitment	No
Secondary	Disease Activity Score in 28 joints (DAS-28)		At recruitment	No
Secondary	Disease Activity Score (DAS)		At recruitment	No