Targeted Ultrasound in Rheumatoid Arthritis (TURA)
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|ClinicalTrials.gov Identifier: NCT02056184|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : October 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Targeted Ultrasound||Drug: Adalimumab||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Targeted Ultrasound in Rheumatoid Arthritis|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||July 2019|
Active Comparator: Adalimumab, masked ultrasound
Adalimumab and blinded ultrasound.
Other Name: Humira
Experimental: Adalimumab, unmasked ultrasound
Adalimumab and open ultrasound.
Other Name: Humira
- Proportion of patients in whom there is a decrease in Power Doppler (PD) at week 48 after randomisation. [ Time Frame: Week 48 ]
- Total PD score at week 48 [ Time Frame: Week 48 ]
- GS (Grey Scale ultrasound)) at week 48 [ Time Frame: Week 48 ]
- X-ray scores at 48 and 96 weeks. [ Time Frame: Weeks 48 and 96 ]
- HAQ-DI scores at 48 and 96 weeks [ Time Frame: Weeks 48 and 96 ]Disability Index questionnaire
- Bone densitometry scores at weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ]
- RA-WIS score at weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ]Rheumatoid Arthritis Work Instability Scale
- EQ-5D score at weeks 48 and 96 [ Time Frame: Weeks 48 and 96 ]Quality of life questionnaire
- Proportion of patients requiring biological therapy at 48 and 96 weeks [ Time Frame: Weeks 48 and 96 ]
- Development of Co-Morbidity Evaluation. [ Time Frame: Week 96 ]Data collected will include total steroid exposure, number of infection events, blood pressure control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056184
|Leeds Teaching Hospitals NHS Trust|
|Leeds, United Kingdom|