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

NCT ID: NCT05544292

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-05

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Immune-related Adverse Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Antiinflammatory/DMARDs

Antiinflammatory/DMARDs

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Hospital of Southern Norway Trust

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marte S Heiberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet Hospital

Locations

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Ålesund Hospital

Ålesund, , Norway

Site Status

Hospital of Southern Norway Trust

Kristiansand, , Norway

Site Status

Levanger Hospital

Levanger, , Norway

Site Status

Diakonhjemmet Hospital

Oslo, , Norway

Site Status

University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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DS 00469

Identifier Type: -

Identifier Source: org_study_id

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