Immune-related Adverse EventRIMRANCT05544292
Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors
An observational study of Immune-related Adverse Event, run by Diakonhjemmet Hospital at 5 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-related Adverse Event
- What is being tested?
- Antiinflammatory/DMARDs
- How many people
- 69 participants
- Where
- 5 sitesNorway
- Study dates
- 5 Mar 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred with symptoms of a rheumatic condition after cancer treatment with a check point inhibitor
Who may be able to join
- 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
Who cannot join
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Ålesund Hospital
Ålesund
Hospital of Southern Norway Trust
Kristiansand
Levanger Hospital
Levanger
Diakonhjemmet Hospital
Oslo
University Hospital of North Norway
Tromsø
About this study
Official title: 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.
- Conditions
- Immune-related Adverse Event
- Being tested
- Antiinflammatory/DMARDs
- Keywords
- arthritis, check point inhibitor, irAE
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiinflammatory/DMARDsOther
Antiinflammatory/DMARDs
What is being measured
The primary outcome is the main question the study is designed to answer.
Swollen joint count
Numbers (0-66)
Measured: 1 year follow-up
Secondary outcomes (2)
C reactive protein
mg/L
Measured: 1 year
Proportion of pateints with arthritis after one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start5 Mar 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-related Adverse EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Alesund Hospital, University Hospital of North Norway, Hospital of Southern Norway Trust, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Marte S Heiberg, MD, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544292
- Sponsor's protocol ID
- DS 00469
- Acronym
- RIMRA
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05544292
- Acronym / sponsor ID
- RIMRA / DS 00469
- Conditions
- Immune-related Adverse Event
- Keywords
- arthritis, check point inhibitor, irAE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Alesund Hospital, University Hospital of North Norway, Hospital of Southern Norway Trust, Helse Nord-Trøndelag HF
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred with symptoms of a rheumatic condition after cancer treatment with a check point inhibitor
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiinflammatory/DMARDsAntiinflammatory/DMARDs | Other | – |
Primary outcome
Swollen joint count
Time frame: 1 year follow-up
Numbers (0-66)
2 secondary outcomes
C reactive protein
Time frame: 1 year
Proportion of pateints with arthritis after one year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marte S Heiberg, MD, PhD principal investigator
Diakonhjemmet Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune-related Adverse Event, run by Diakonhjemmet Hospital at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swollen joint count (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.