Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors

Immune-related Adverse Event Clinical Trial

— RIMRA  

Official title:

Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors - a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544292
• Other study ID #: DS 00469
• Status: Recruiting
• Start date: March 5, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: Diakonhjemmet Hospital
• Contact: Marte S Heiberg, MD, PhD
• Phone: 004722454086
• Email: marte.schrumpf[@]diakonsyk.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult

Related Conditions & MeSH terms

• Immune-related Adverse Event
• Rheumatic Diseases

Intervention

Other:
• Antiinflammatory/DMARDs
Antiinflammatory/DMARDs

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Hospital of Southern Norway Trust	Kristiansand
Norway	Levanger Hospital	Levanger
Norway	Diakonhjemmet Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø

Sponsors (6)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Alesund Hospital, Helse Nord-Trøndelag HF, Hospital of Southern Norway Trust, Oslo University Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swollen joint count	Numbers (0-66)	1 year follow-up
Secondary	C reactive protein	mg/L	1 year
Secondary	Proportion of pateints with arthritis after one year		1 year