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

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

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.

Study Overview

• Status: Completed
• Conditions: Immune-related Adverse Event
• Intervention / Treatment: Other: Antiinflammatory/DMARDs

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Norway
  • Kristiansand, Norway
    • Hospital of Southern Norway Trust
  • Levanger, Norway
    • Levanger hospital
  • Oslo, Norway
    • Diakonhjemmet Hospital
  • Tromsø, Norway
    • University Hospital of North Norway
  • Ålesund, Norway
    • Ålesund Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients referred with symptoms of a rheumatic condition after cancer treatment with a check point inhibitor

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swollen joint count	Numbers (0-66)	1 year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C reactive protein	mg/L	1 year
Proportion of pateints with arthritis after one year		1 year

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: Oslo University Hospital; University Hospital of North Norway; Helse Nord-Trøndelag HF; Alesund Hospital; Hospital of Southern Norway Trust
• Investigators: Principal Investigator: Marte S Heiberg, MD, PhD, Diakonhjemmet Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: arthritis; check point inhibitor; irAE
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Anti-Inflammatory Agents
• Other Study ID Numbers: DS 00469

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No