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 multiple parts of the musculoskeletal system, skin and nails. It has a very varied disease expression and can be difficult to assess by 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 objective 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 relationship 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 personnel at the center.
Recruitment for the study is ongoing at 12 Norwegian hospitals: Diakonhjemmet, Ålesund, Førde, Haukeland, Martina Hansen, St. Olavs, Helgelandssykehuset, Drammen, UNN, Lillehammer, Haugesund and Kristiansand.
In this consent form 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.
WHAT DOES THE STUDY INVOLVE?
The study will include patients who are about to start their first disease-modifying drug. The patients will be randomly assigned to 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 examinations of the back 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 the clinical features of the patient according to established clinical practice and recommendations, but in the intervention group, information from diagnostic imaging will also influence the choice. In both groups, the patients will be 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 also a criterion for achieved treatment goals.
The follow-up lasts for 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, imaging and monitoring of any side effects of treatment. Blood samples are also taken for the biobank at three time points. The study's randomized design 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. 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 the understanding of the disease within psoriatic arthritis.