A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

April 10, 2026 updated by: M.D. Anderson Cancer Center
To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
  2. To explore domains relevant to participants experiencing rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, and attitudes to domains identified from the literature

Study Type

Observational

Enrollment (Estimated)

20

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

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Y. Jeff Li, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

MD Anderson Cancer Center

Description

Inclusion Criteria

The criteria are:

  • Patients aged 18 years and above
  • English (conversational level) speaking, with the ability to give informed consent
  • Patients with a rheumatologist clinician diagnosis of inflammatory arthritis irAE or PMR irAE following ICI therapy

Exclusion Criteria

  • Acutely life-threatening or worsening cancer
  • Hearing impairment functionally limiting participation in verbal interview

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
Safety and Adverse Events (AEs).
Time Frame: Through study completion; an average of 1 year
Incidence of Adverse Events
Through study completion; an average of 1 year

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Y. Jeff Li, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 11, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0342
  • NCI-2024-07031 (Other Identifier: NCI-CTRP Clinical Trials Registry)

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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