NOR Sprint
Follow-up of newly diagnosed patients with psoriatic arthritis with and without imaging
Project Manager
PhD fellow
ABOUT THE PROJECT
Psoriatic arthritis is an inflammatory disease that can affect several parts of the musculoskeletal system, skin and nails. It gives very varied disease expressions and it can be difficult to assess during clinical examination. Ultrasound and magnetic resonance (MR) imaging can visualize inflammatory activity, but it is not known whether allowing information from imaging to influence treatment choices leads to better disease control in patients.
The project's aim is to investigate whether additional information from structured imaging examinations contributes to significantly better disease control in patients with psoriatic arthritis early in the course of treatment.
The extensive data collection will also provide a basis for exploring and increasing understanding of the connection between clinical features of the patients, disease course and treatment response.
WHO CAN JOIN?
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 active in the study can participate if they meet the criteria for participation. This is assessed by study staff at the centre.
Recruitment for the study is ongoing at several hospitals throughout the country, including Tromsø, Trondheim, Diakonhjemmet and Haukeland.
You can read more about the project in this letter of consent. NB. This consent form is for reading only. Consent forms for signature are available at each individual study centre.
WHAT DOES THE STUDY INCLUDE?
The study will include patients who will start with their first disease-modifying drug. The patients are randomly divided into two groups, one group (the control group) which is followed with standard clinical follow-up and one group (the intervention group) where the attending physician receives additional information from MRI examinations of the back at the start of the study and performs ultrasound of joints and tendons at each examination. In both groups, the choice of type of treatment is guided by the patient's clinical features in accordance with established clinical practice and recommendations, but in the intervention group information from diagnostic imaging will also influence the choice. In both groups, the 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, absence of inflammatory activity on ultrasound examination is also a criterion for achieving treatment goals.
The follow-up lasts over 2 years with frequent assessments at the start of treatment (every month), later increasing up to 4 months (a total of 12 assessments). The patients are thoroughly surveyed 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 to the biobank at three instances. The study's randomized design contributes to reliable results regarding the effect of diagnostic imaging in the follow-up of the patient group, as well as cost-effectiveness for such follow-up. As 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 within psoriatic arthritis.