A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
2 other identifiers
observational
20
1 country
1
Brief Summary
To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2024
CompletedFirst Submitted
Initial submission to the registry
October 16, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
April 13, 2026
April 1, 2026
3.6 years
October 16, 2024
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs).
Incidence of Adverse Events
Through study completion; an average of 1 year
Eligibility Criteria
MD Anderson Cancer Center
You may qualify if:
- 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
You may not qualify if:
- Acutely life-threatening or worsening cancer
- Hearing impairment functionally limiting participation in verbal interview
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Y. Jeff Li, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2024
First Posted
October 17, 2024
Study Start
September 11, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04