Status:
RECRUITING
INSELMA - a Randomised Controlled Trial
Lead Sponsor:
The Danish Center for Expertise in Rheumatology
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Background: Patients with inflammatory arthritis (IA) experience substantial impact of their disease despite optimal pharmacological treatment. To be able to manage these challenges effectively, pati...
Detailed Description
Approximately 30% of patients with inflammatory arthritis (IA) experience substantial disease impact despite optimal pharmacological treatment. In this trial, autoimmune chronic inflammatory arthritis...
Eligibility Criteria
Inclusion
- Adults aged 18 years or older
- Diagnosed with RA, PsA, or axSpA by a rheumatologist for at least 24 months. Connected to the rheumatology department of one of the participating hospitals for at least two years
- Answer "no" to the Patient Acceptable Symptom State (PASS) (36), "Think about all the ways your arthritis has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable to you?" or
- report ≥60 on at least one Visual Analogue Scale (VAS) (0-100) for fatigue, pain, or global assessment of the impact of the disease
Exclusion
- Planned change or a change during the past three months in treatment with disease modifying anti-rheumatic drugs (DMARDs) or glucocorticoids.
- Participation in other studies of relevance for the outcomes in INSELMA (i.e. TRACE, WORK-ON, SPINCODE, COMFI, PLATE, KRAM-offer).
- Not able to speak and understand Danish sufficiently to participate without a translator
- Unstable psychiatric illness, cognitive impairment or other physical or mental issues that impede the ability to give informed consent to participation.
- Current alcohol or drug use disorder documented in their medical journal
- Pregnant or nursing a baby
- Planned or ongoing rehabilitation at the Danish Hospital for Rheumatic Diseases or Sano, a pain or sleep clinic
- Ongoing application for early retirement or planned surgery requiring admission
- Did not participate in the INSELMA feasibility study or is a patient research partner in INSELMA
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06583980
Start Date
September 5 2024
End Date
August 31 2027
Last Update
August 19 2025
Active Locations (3)
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1
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
2
Rigshospitalet-Glostrup
Glostrup Municipality, Denmark, 2600
3
Danish Hospital for Rheumatic Diseases
Sønderborg, Denmark, 6400