Remote Monitoring of Axial Spondyloarthritis

Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services

The ReMonit study is a 18-months, non-inferiority randomized, controlled trial with three parallel arms to determine if two, new follow-up strategies for patients with axial spondyloarthritis (axSpA) are non-inferior in maintaining stable, low disease activity over time compared to the conventional follow-up regimen with regular hospital visits.

The trial will include Norwegian adult males and females with axial spondyloarthritis.

240 participants will be randomized 1:1:1 to either:

1. Control group: a. Usual care, i.e. conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month
2. Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform
3. Patient-initiated care: no pre-scheduled visits or remote monitoring

The study has 18 months follow-up. We will use a 15% non-inferiority margin.

The study will also include qualitative research including semi-structured interviews and observations of patients in the two intervention groups and health professionals involved in the study. The interviews will explore experiences with remote monitoring and video consultations.

Inclusion Criteria:

• Male or non-pregnant, non-nursing female >18 years of age at screening
• Patients with a diagnosis of axSpA who fulfil the diagnostic Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
• Stable medical treatment with TNFi the last 6 months
• Low disease activity (ASDAS<2.1) at inclusion
• Capable of understanding the Norwegian language and of signing an informed consent form

Exclusion Criteria:

Medical conditions:

• Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
• Indications of active tuberculosis (TB)

Diagnostic assessments:

• Abnormal renal function, defined as serum creatinine >142 µmol/L in female and >168 µmol/L in male, or glomerular filtration rate (GFR) <40 mL/min/1.73 m2
• Abnormal liver function (defined as Alanine Transaminase (ALT) >3x upper normal limit), active or recent hepatitis
• Leukopenia and/or thrombocytopenia

Other:

• Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
• Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible