Rheumatoid Arthritis, Targeted Ultrasound
Conditions
Brief 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.
Interventions
DRUGAdalimumab
Sponsors
AbbVie
Theorem
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Confirmed Participation by Informed Consent * Patients fulfilling the ACR/EULAR classification criteria 2010 for rheumatoid arthritis (RA) Patients must be: * Within the first year of starting on methotrexate AND * Within 5 years of diagnosis AND * In a stable clinical disease activity state (clinical remission/LDAS /other physician deemed state) on methotrexate (as monotherapy or combination +/≤ prednisolone 5mg oral daily) for at least 8 successive weeks (with no change in Disease-Modifying Anti-Rheumatic Drugs (DMARD) +/steroid therapy - see
Exclusion criteria
) * Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Subjects must agree to use adequate contraception during the study and for at least 5 months after study completion (or longer if on relevant therapy and in line with local regulations). * Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 5 months after the end of the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in whom there is a decrease in Power Doppler (PD) at week 48 after randomisation. | Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Total PD score at week 48 | Week 48 |
Other
| Measure | Time frame | Description |
|---|---|---|
| HAQ-DI scores at 48 and 96 weeks | Weeks 48 and 96 | Disability Index questionnaire |
| Bone densitometry scores at weeks 48 and 96 | Weeks 48 and 96 | — |
| RA-WIS score at weeks 48 and 96 | Weeks 48 and 96 | Rheumatoid Arthritis Work Instability Scale |
| GS (Grey Scale ultrasound)) at week 48 | Week 48 | — |
| Proportion of patients requiring biological therapy at 48 and 96 weeks | Weeks 48 and 96 | — |
| Development of Co-Morbidity Evaluation. | Week 96 | Data collected will include total steroid exposure, number of infection events, blood pressure control. |
| EQ-5D score at weeks 48 and 96 | Weeks 48 and 96 | Quality of life questionnaire |
| X-ray scores at 48 and 96 weeks. | Weeks 48 and 96 | — |
Countries
United Kingdom
Outcome results
None listed