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Completed

NCT Number: NCT05544292

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

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.

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Key information

Conditions

Immune-related Adverse Event Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Southern Norway Trust, Kristiansand, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antiinflammatory/DMARDs

Other

Antiinflammatory/DMARDs

Primary outcomes

  1. Swollen joint count

    Time frame: 1 year follow-up

    Numbers (0-66)

Secondary outcomes

  1. C reactive protein

    Time frame: 1 year

    mg/L

  2. Proportion of pateints with arthritis after one year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Alesund Hospital
  • Helse Nord-Trøndelag HF
  • Hospital of Southern Norway Trust
  • Oslo University Hospital
  • University Hospital of North Norway

Registry information

Official study title

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

Acronym: RIMRA

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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