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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06647134

Enrollment

Registered

2024-10-17

Start date

2024-09-11

Completion date

2028-03-31

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Immune Checkpoint Inhibitors, Polymyalgia Rheumatica

Keywords

arthritis, polymyalgia rheumatica, immune related adverse events

Brief summary

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and Adverse Events (AEs).	Through study completion; an average of 1 year	Incidence of Adverse Events

Countries

United States

Contacts

CONTACTY. Jeff Li, MD

yli61@mdanderson.org713-409-1565

PRINCIPAL_INVESTIGATORY. Jeff Li, MD

M.D. Anderson Cancer Center

Outcome results