Remote Monitoring of Axial Spondyloarthritis

NCT05031767 | Completed

• 1 other identifier: REK no.:229187
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Axial Spondyloarthritis

Keywords

rheumatic diseases; musculoskeletal diseases; joint diseases; arthritis

Outcome Measures

Primary Outcomes (3)

• Low disease activity at follow-up

  The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 6-months follow-up

  6 months

• Low disease activity at follow-up

  The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 12- months follow-up

  12 months

• Low disease activity at follow-up

  The proportion of patients with low disease activity (defined as ASDAS \<2.1) at the 18-months follow-up

  18 months

Secondary Outcomes (44)

• Ankylosing Spondylitis Disease Activity Score (ASDAS)

  Baseline, 6, 12 and 18 months

• Ankylosing Spondylitis Disease Activity Score (ASDAS)

  Every month, maximum 18 months

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline, 6, 12 and 18 months

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Every month, maximum 18 months

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline, 3, 6, 9, 12, 15 and 18 months

Study Arms (3)

Usual care

ACTIVE COMPARATOR

Conventional current follow-up strategy

Other: Usual care

Remote monitoring

EXPERIMENTAL

Remote monitoring by health professionals at the hospital

Other: Remote monitoring

Patient-initiated care

EXPERIMENTAL

No pre-scheduled visits or remote monitoring.

Other: Patient-initiated care

Interventions

Usual care OTHER

Conventional follow-up strategy with blood tests, patient-reported outcomes, and pre-scheduled visits at the hospital every 6th month. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital.

Usual care

Remote monitoring OTHER

Hospital health professionals perform remote monitoring of frequent patient-reported outcomes, blood test results, and physical activity data available on a digital platform. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital .

Remote monitoring

Patient-initiated care OTHER

No pre-scheduled visits or remote monitoring. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital.

Patient-initiated care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Capable of understanding the Norwegian language and of signing an informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

Related Publications (1)

• Berg IJ, Tveter AT, Bakland G, Hakim S, Kristianslund EK, Lillegraven S, Macfarlane GJ, Moholt E, Provan SA, Sexton J, Thomassen EE, De Thurah A, Gossec L, Haavardsholm EA, Osteras N. Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial. JMIR Res Protoc. 2023 Dec 27;12:e52872. doi: 10.2196/52872.

  PMID: 38150310 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis; Rheumatic Diseases; Musculoskeletal Diseases; Joint Diseases; Arthritis

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Tore Kvien, MD, Professor em

  Diakonhjemmet Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 2, 2021
• Study Start: September 7, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)