PROJECT

NOR-Sprint

Follow-up of newly diagnosed patients with psoriatic arthritis with and without imaging

project manager

About the project

Psoriatic arthritis is an inflammatory disease that can affect several parts of the musculoskeletal system, skin and nails. It presents with highly varied disease expression and can be difficult to assess on clinical examination. Ultrasound and magnetic resonance imaging (MRI) can visualize inflammatory activity, but it is not known whether allowing imaging information to influence treatment choices leads to better disease control in patients.

The aim of the project is to investigate whether additional information from structured imaging examinations contributes to significantly improved disease control in patients with psoriatic arthritis early in the course of treatment.

In addition, the comprehensive data collection will provide a basis for exploring and better understanding the relationship between clinical features of patients, disease progression and treatment response.

Who can participate?

The study includes adult patients with psoriatic arthritis who are about to start their first disease-modifying (immunosuppressive) medication. Patients at the centers that are actively participating in the study can be included if they meet the eligibility criteria. This is assessed by study staff at the center.

Recruitment in the study is ongoing.

In this consent letter you can read more about the project. NB. This consent form is for reading only. Consent forms for signature are available at each study center.

Project arrangement

The study will include patients who are about to start their first disease-modifying drug. Patients will be randomized into two groups, one group (the control group) that will be followed with standard clinical follow-up and one group (the intervention group) where the treating physician will receive additional information from MRI scans of the spine at the start of the study and perform ultrasound of joints and tendons at each examination. In both groups, the choice of treatment type is guided by clinical features of the patient according to established clinical practice and recommendations, but in the intervention group, imaging information will also influence the choice. In both groups, patients are followed closely and according to a treatment algorithm where treatment is escalated according to the achievement of treatment goals. In the control group, treatment goals are defined by symptoms, clinical examination and blood tests, but in the intervention group, the absence of inflammatory activity on ultrasound examination is an additional criterion for achieving treatment goals.

Follow-up is over 2 years with frequent assessments at the start of treatment (every month), later increasing up to 4 months (12 assessments in total). Patients are thoroughly assessed with medically relevant background information, clinical examination, blood tests, self-reporting of symptoms and function, diagnostic imaging and monitoring of any side effects of treatment. Blood samples are also taken for biobanking at three time points. The randomized design of the study contributes to reliable results regarding the effect of imaging in the follow-up of the patient group, as well as the cost-effectiveness of such follow-up. Since a significant proportion of patients with psoriatic arthritis today do not achieve a desirable disease state, this is of great interest. At the same time, the study will be able to answer a number of other questions related to disease understanding in psoriatic arthritis.

Partners

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