NCT05496855Active, not recruiting
Remote Care in People With Rheumatoid Arthritis
Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases
Source: ClinicalTrials.gov · Last updated 20 Apr 2025
Brief summary (registry, in English)
This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up compared to the conventional follow-up regimen with regular hospital visits.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 4 Aug 2022
- Start date
- 29 Sept 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Diakonhjemmet Hospital
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05496855
What you commit to
- Study type: Interventional
- Planned participants: 228
- From 29 Sept 2022 to the primary completion date, 30 Jun 2026
- 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.
Prior treatment
- Treated with intravenous DMARD (e.g., rituximab and infliximab)
- Diagnostic assessments:
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)
- 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 Aspartate Transaminate (AST)/Alanine Transaminase (ALT) \>3 x 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)
- Deemed unsuitable for remote monitoring by medical doctor
Who the study is looking for
- Male or non-pregnant, non-nursing female ≥18 years of age at screening
- Patients with a diagnosis of RA who fulfil the 2010 ACR/EULAR diagnostic criteria24 (see Appendix 5, 10.4)
- Medical treatment with cs/ts/bDMARDs (incl. prednisolone) considered stable by the healthcare provider the last 6 months
- Low disease activity or remission (CDAI\<10 / DAS28\<3.2) at inclusion
- \<2 swollen joints
- Not deemed inappropriate for remote monitoring by the healthcare provider
- Capable of understanding and signing an informed consent form
- Access to a smartphone or tablet
- Able to speak and understand Norwegian language
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.