Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors
- Conditions
- Immune-related Adverse Event
- Registration Number
- NCT05544292
- Lead Sponsor
- Diakonhjemmet Hospital
- Brief Summary
RIMRA is a prospective, longitudinal, observational study including patients with de novo symptoms of rheumatic disease or a flare of established rheumatic disease after treatment with an immune check point inhibitor. The aim of the study is to describe the clinical presentation, disease course and outcome of rheumatic irAEs in patients treated with immune check point inhibitors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- De novo symptoms of rheumatic disease or a flare of established rheumatic disease after >/= 1 dose of treatment with an immune check point inhibitor
- Adult patients (> 18 years)
- Subject capable of understanding and signing an informed consent form
• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Swollen joint count 1 year follow-up Numbers (0-66)
- Secondary Outcome Measures
Name Time Method C reactive protein 1 year mg/L
Proportion of pateints with arthritis after one year 1 year
Trial Locations
- Locations (5)
University Hospital of North Norway
🇳🇴Tromsø, Norway
Diakonhjemmet Hospital
🇳🇴Oslo, Norway
Hospital of Southern Norway Trust
🇳🇴Kristiansand, Norway
Levanger Hospital
🇳🇴Levanger, Norway
Ålesund Hospital
🇳🇴Ålesund, Norway