Bayview
Baltimore, Maryland, 21224, United States
Active, Not Recruiting
NCT Number: NCT07737535
Investigating Clinical Heterogeneity in Immune Checkpoint Inhibitor-induced Inflammatory Arthritis
Immune checkpoint inhibitors (ICI) can cause immune related adverse events like inflammatory arthritis (ICI-IA). ICI-IA is a new and impactful condition, but there is limited understanding of pathogenesis, natural history, and response to treatments. The study will have two main goals. 1. Evaluate efficacy of steroid sparing immunosuppression and determinants of ICI-IA persistence. 2. Identify biomarkers that predict ICI-IA disease severity and initial treatment-associated response.
These questions will be answered using the RADIOS cohort, a prospective cohort of patients with rheumatic immune related adverse events due to ICI therapy.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Immune checkpoint inhibitors (ICI) were first approved in the US in 2011, and ICI-induced inflammatory arthritis (ICI-IA) was first described in the literature in isolated case reports and then in the investigator's case series in 2015-2016. ICI-IA has been recognized as a disease entity for only 10 years, thus there are fundamental features of the disease which are yet to be defined. These include understanding the clinical heterogeneity of ICI-IA, factors influencing treatment selection and response to treatment, and prognostic biomarkers for ICI-IA persistence, all of which will be addressed in the proposed studies. The RADIOS consortium, a multicenter consortium already approved as a research resource at Johns Hopkins, will provide all clinical data for this study. Investigators at outside sites that are part of the RADIOS consortium are collaborating to add their expertise in statistical analysis and to have an adequate number of samples for the biomarker work.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients enrolled in RADIOS (IRB00263113) with immune checkpoint inhibitor-induced inflammatory arthritis will be included.
Exclusion criteria
- Preexisting systemic autoimmune disease
Treatment and study plan
Primary outcomes
-
Disease activity as assessed by the Clinical Disease Activity Index (CDAI)
Time frame: baseline, at 2-4 month follow up visit, at 3 months and 6 months post ICI cessation
Add four numbers to get a total score from 0 to 76. 1)Tender Joint Count (0-28): How many of 28 specific joints hurt when touched. 2)Swollen Joint Count (0-28): How many of 28 specific joints are swollen. 3)Patient Global Assessment (0-10): How the patient feels their overall health is doing. 4)Provider Global Assessment (0-10): How the doctor feels the patient's disease is doing.
Sponsors and collaborators
Lead sponsor
Johns Hopkins University
Other
Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2031
- Study completion
- 2031
- First posted
- Jul 30, 2026
- Registry last updated
- Jul 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.