Recruiting

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

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06647134

Conditions

Arthritis

Polymyalgia Rheumatica

Immune Checkpoint Inhibitors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Arthritis

Polymyalgia Rheumatica

Immune Checkpoint Inhibitors

Study ID

NCT06647134

Start date

Sep 11, 2024

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Y. Jeff Li, MD

713-409-1565 yli61@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Y. Jeff Li, MD

713-409-1565 yli61@mdanderson.org

Principal Investigator:

Y. Jeff Li, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

arthritis
polymyalgia rheumatica
immune related adverse events

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-13.