NCT07737535

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
60mo left

Started Jul 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jul 2031

Study Start

First participant enrolled

July 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

July 27, 2026

Last Update Submit

July 29, 2026

Conditions

Immune Checkpoint Inhibitor-Induced Inflammatory Arthritis

Keywords

Checkpoint Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, at 2-4 month follow up visit, at 3 months and 6 months post ICI cessation

Study Arms (1)

ICI-IA

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rheumatologist diagnosed immune checkpoint inhibitor-induced inflammatory arthritis

You may qualify if:

  • Patients enrolled in RADIOS (IRB00263113) with immune checkpoint inhibitor-induced inflammatory arthritis will be included.

You may not qualify if:

  • Preexisting systemic autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayview

Baltimore, Maryland, 21224, United States

Location

Study Officials

  • Laura Cappelli, MD

    Johns Hopkins Division of Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations

US(1)