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

September 15, 2022 updated by: Diakonhjemmet Hospital

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Kristiansand, Norway
        • Recruiting
        • Hospital of Southern Norway Trust
        • Contact:
          • Helle Bitter
      • Levanger, Norway
        • Not yet recruiting
        • Levanger Hospital
        • Contact:
          • Benedikte Døskeland
      • Oslo, Norway
      • Tromsø, Norway
        • Recruiting
        • University Hospital of North Norway
      • Ålesund, Norway
        • Recruiting
        • Alesund Hospital
        • Contact:
          • Karen Irgens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2018

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

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)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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