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RecruitingNCT06647134Updated Oct 6, 2026

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

An observational study in Arthritis, Polymyalgia Rheumatica and Immune Checkpoint Inhibitors, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by M.D. Anderson Cancer Center · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Arthritis
  • Polymyalgia Rheumatica
  • Immune Checkpoint Inhibitors

Keywords

  • arthritis
  • polymyalgia rheumatica
  • immune related adverse events
03

In context

Arthritis

843 studies on the registry are indexed under Arthritis; 118 are open to participants now.

This study's planned enrollment of 20 is below the median of 151 across 202 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

MD Anderson Cancer Center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The criteria are:

  • Patients aged 18 years and above
  • English (conversational level) speaking, with the ability to give
  • Patients with a rheumatologist clinician diagnosis of inflammatory arthritis irAE or PMR irAE following ICI therapy

Exclusion criteria

Exclusion Criteria

  • Acutely life-threatening or worsening cancer
  • Hearing impairment functionally limiting participation in verbal interview
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Safety and Adverse Events (AEs).

    Incidence of Adverse Events

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06647134
Responsible party
Sponsor
First posted
Oct 17, 2024
Start date
Sep 11, 2024
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Oct 6, 2026

Study contacts

Y. Jeff Li, MD
Contact
yli61@mdanderson.org
713-409-1565
Y. Jeff Li, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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