Understanding the impact of immune-related side effects in arthritis patients after immunotherapy
A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
This study looks at how immune-related side effects from immunotherapy affect the daily lives of arthritis patients and what they think about these experiences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06647134 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the severity and nature of experiences related to rheumatic immune-related adverse events (irAEs) in patients who have undergone immune checkpoint inhibitor immunotherapy. It will explore the functional impact of these adverse events on participants' lives and gather insights into their attitudes towards these experiences. By conducting qualitative assessments, the study seeks to provide a deeper understanding of the challenges faced by patients with inflammatory arthritis or polymyalgia rheumatica following treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of inflammatory arthritis or polymyalgia rheumatica related to immune checkpoint inhibitor therapy.
Not a fit: Patients with acutely life-threatening cancer or significant hearing impairments that limit participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients experiencing adverse effects from immunotherapy.
How similar studies have performed: While this study focuses on a specific aspect of immune-related adverse events, similar qualitative assessments have shown promise in understanding patient experiences in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Y. Jeff Li, MD — M.D. Anderson Cancer Center
- Study coordinator: Y. Jeff Li, MD
- Email: yli61@mdanderson.org
- Phone: 713-409-1565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.