Rheumatoid Arthritis Clinical Trial
Official title:
Targeted Ultrasound in Rheumatoid Arthritis
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.
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.
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