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

To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.

Recruiting

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Key information

Conditions

Arthritis Connective Tissue Diseases Immune Checkpoint Inhibitors Joint Diseases Muscular Diseases Musculoskeletal Diseases Polymyalgia Rheumatica Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Y. Jeff Li, MD

CONTACT

[email protected]

713-409-1565

Y. Jeff Li, MD

PRINCIPAL_INVESTIGATOR

About this study

To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Safety and Adverse Events (AEs).

Time frame: Through study completion; an average of 1 year

Incidence of Adverse Events

Study contacts

Contact information is provided by the study sponsor or research team.

Y. Jeff Li, MD

CONTACT

[email protected]

713-409-1565

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Oct 17, 2024
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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