NCT02056184

Targeted Ultrasound in Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether therapy modifications (including addition of ultrasound-guided treatment change) can change imaging results in patients with early rheumatoid arthritis in a stable clinical disease activity state.

Detailed description

Rheumatoid arthritis is the most common form of inflammatory arthritis. It is a condition where the body's joints become swollen and damaged. Currently, the approach used to manage rheumatoid arthritis is the so-called 'Treat to Target' approach. The aim of this approach to treatment is to achieve the absence of signs and symptoms, or best possible state of low disease activity. It requires the use of frequent routine clinical assessments to help determine what treatment to use. Ultrasound imaging (using sound waves to take images of the joints and surrounding tissues) has been shown to be better than standard clinical measurements in detecting disease activity. Doctors are already using ultrasound imaging as part of their decisionmaking, in terms of diagnosis and altering treatments, but it is has not been clearly shown if this is associated with a better control of the disease. Participants will be randomly put into 1 of 2 treatment groups (standard treatment group or the imaging group). All patients will also undergo the ultrasound assessment. In the standard treatment arm, the doctor will not know the ultrasound result and will base treatment on the routine disease activity score alone. In the imaging group, doctors will use routine clinical disease activity score plus the ultrasound result to make decisions on which treatment is given and treatment will be increased if necessary. However, for patients in the imaging group, even if their rheumatoid arthritis remains stable as judged by the disease activity score, treatment will be increased based on signs of active disease on the ultrasound. Participation will last for 2 years. During the study participants will be required to attend 8 clinic visits. Approximately 400 patients from a number of countries in Europe and Japan are expected to take part in the study.

Conditions

• Rheumatoid Arthritis
• Targeted Ultrasound

Interventions

Type	Name	Description
DRUG	Adalimumab

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-12-01
• Completion: 2019-07-01
• First posted: 2014-02-05
• Last updated: 2019-10-31

Locations

1 site across 1 country: United Kingdom