Immune Checkpoint Inhibitor-Induced Inflammatory ArthritisNCT07737535
Investigating Clinical Heterogeneity in Immune Checkpoint Inhibitor-induced Inflammatory Arthritis
An observational study of Immune Checkpoint Inhibitor-Induced Inflammatory Arthritis, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Immune Checkpoint Inhibitor-Induced Inflammatory Arthritis
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2031
- How long will I take part?
- 5 Years
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatologist diagnosed immune checkpoint inhibitor-induced inflammatory arthritis
Who may be able to join
- Patients enrolled in RADIOS (IRB00263113) with immune checkpoint inhibitor-induced inflammatory arthritis will be included.
Who cannot join
- Preexisting systemic autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Keywords
- Checkpoint Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICI-IA | Patients with rheumatologist diagnosed immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity as assessed by the Clinical Disease Activity Index (CDAI)
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.
Measured: baseline, at 2-4 month follow up visit, at 3 months and 6 months post ICI cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitor-Induced Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Laura Cappelli, MD, Principal investigator, Johns Hopkins Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737535
- Sponsor's protocol ID
- IRB00559637
- Other IDs
- R01AR085636
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No