ArthritisNCT06647134
A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
An observational study of Arthritis and Polymyalgia Rheumatica, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Polymyalgia Rheumatica, Immune Checkpoint Inhibitors
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 31 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
- 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
Who cannot join
- Acutely life-threatening or worsening cancer
- Hearing impairment functionally limiting participation in verbal interview
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Y. Jeff Li, MD, 713-409-1565, yli61@mdanderson.org
Y. Jeff Li, MD
About this study
To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.
Read the detailed description
- To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
- 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
- Keywords
- arthritis, polymyalgia rheumatica, immune related adverse events
- Medical subject headings
- Arthritis, Polymyalgia Rheumatica
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs).
Incidence of Adverse Events
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start11 Sep 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Y. Jeff Li, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647134
- Sponsor's protocol ID
- 2024-0342
- Other IDs
- NCI-2024-07031
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No