A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Arthritis, Polymyalgia Rheumatica, Immune Checkpoint Inhibitors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Safety and Adverse Events (AEs). [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06647134 · 2024-0342 · NCI-2024-07031