NCT05544292

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

6.8 years

First QC Date

August 17, 2022

Last Update Submit

August 19, 2025

Conditions

Immune-related Adverse Event

Keywords

arthritischeck point inhibitorirAE

Outcome Measures

Primary Outcomes (1)

  • Swollen joint count

    Numbers (0-66)

    1 year follow-up

Secondary Outcomes (2)

  • C reactive protein

    1 year

  • Proportion of pateints with arthritis after one year

    1 year

Interventions

Antiinflammatory/DMARDsOTHER

Antiinflammatory/DMARDs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ålesund Hospital

Ålesund, Norway

Location

Hospital of Southern Norway Trust

Kristiansand, Norway

Location

Levanger Hospital

Levanger, Norway

Location

Diakonhjemmet Hospital

Oslo, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and whole blood samples are collected at baseline and after 3 months

MeSH Terms

Conditions

Arthritis

Interventions

Anti-Inflammatory AgentsAntirheumatic Agents

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Marte S Heiberg, MD, PhD

    Diakonhjemmet Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

September 16, 2022

Study Start

March 5, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations

NO(5)