NCT05031767Completed
Remote Monitoring of Axial Spondyloarthritis
Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services
Source: ClinicalTrials.gov · Last updated 29 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 243 (actual)
- First submitted
- 23 Aug 2021
- Start date
- 7 Sept 2021
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Diakonhjemmet Hospital
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT05031767
What you commit to
- Study type: Interventional
- Participants enrolled: 243
- From 7 Sept 2021 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
- Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
Lab values
- 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
Other
- Leukopenia and/or thrombocytopenia
- Other:
- Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Diakonhjemmet Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.