A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-11

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rheumatologic Adverse Events and Cancer Immunotherapy

NCT04791150

Oncology Autoimmunity Arthritis +1 more

UNKNOWN NA

Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

NCT00646178

Arthritis Psoriatic

COMPLETED PHASE3

Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

NCT00649545

Rheumatoid Arthritis

APPROVED_FOR_MARKETING

Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

NCT01076959

Rheumatoid Arthritis

COMPLETED

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

NCT01382940

Rheumatoid Arthritis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
2. To explore domains relevant to participants experiencing rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, and attitudes to domains identified from the literature

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis Polymyalgia Rheumatica Immune Checkpoint Inhibitors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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