Investigating Clinical Heterogeneity in Immune Checkpoint Inhibitor-induced Inflammatory Arthritis

Conditions

• Immune Checkpoint Inhibitor-Induced Inflammatory Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Jul 30, 2026

Start date

Jul 1, 2026

Status verified

Jul 2026

Primary completion

Jul 1, 2031

Completion

Jul 1, 2031

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: ICI-IA
  Patients with rheumatologist diagnosed immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA)

Primary Outcome Measure

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 ]

Locations (1)

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