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

• Sponsor: Diakonhjemmet Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05544292
• Collaborator: Oslo University Hospital (Other), Alesund Hospital (Other), University Hospital of North Norway (Other), Hospital of Southern Norway Trust (Other), Helse Nord-Trøndelag HF (Other)
• Enrollment: 80
• Locations: 5
• Anticipated Duration (Months): 93.9
• Patients Per Site: 16
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune-related Adverse Event	Other: Antiinflammatory/DMARDs

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors - a Prospective Observational Study
• Actual Study Start Date: Mar 5, 2018
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Outcome Measures

Primary Outcome Measures

1. Swollen joint count [1 year follow-up]

   Numbers (0-66)

Secondary Outcome Measures

1. C reactive protein [1 year]

   mg/L

2. Proportion of pateints with arthritis after one year [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of Southern Norway Trust	Kristiansand		Norway
2	Levanger Hospital	Levanger		Norway
3	Diakonhjemmet Hospital	Oslo		Norway
4	University Hospital of North Norway	Tromsø		Norway
5	Ålesund Hospital	Ålesund		Norway

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Marte S Heiberg, MD, PhD, Diakonhjemmet Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diakonhjemmet Hospital
• ClinicalTrials.gov Identifier: NCT05544292
• Other Study ID Numbers: DS 00469
• First Posted: Sep 16, 2022
• Last Update Posted: Sep 16, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Diakonhjemmet Hospital: arthritis; check point inhibitor; irAE
• Additional relevant MeSH terms: Rheumatic Diseases; Anti-Inflammatory Agents

Study Results

No Results Posted as of Sep 16, 2022