Biologics And Clinical Immunology Cohort at Sinai

This observational study at Mount Sinai aims to create a registry of patients receiving biologic medications or immune modulators for immunological or autoimmune diseases, or primary immune deficiency. The researchers want to understand how these treatments affect your health over time. They will collect information like your demographics, immune system details, treatment history, and medical records. This will help them learn more about how these treatments work and how to make them more effective. You can join if you are 12 years or older, can give informed consent, receive medical care at Mount Sinai, and are either taking a biologic medication or immune modulator, or are considered a comparison participant by the study team. The main goal is to establish this registry and track information for at least 3 years.

Study design
This is an observational study planning to enroll 800 participants. It is not a treatment study but rather collects information about your existing medical care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Information will be collected and tracked for at least 3 years as part of the registry.

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NCT04784364

Biologics And Clinical Immunology Cohort at Sinai

Recruiting
Not specifiedAges 12+Observational
Icahn School of Medicine at Mount Sinai
~800 participants
Updated 2026-02-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biologics and Clinical Immunology Registry
Measured over 3 years
Immunological Disease
Autoimmune Diseases
Primary Immune Deficiency
1 sites across 1 states
New York1
  • Rachel Miller · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine

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Eligibility criteria

Inclusion

Age 12 years and up.
Able to provide informed consent.
Medical care at Mount Sinai.
Receiving a biologic medication or immune modulator at Mount Sinai, or considered an appropriate negative control or comparison participant by the study team.
  • Biologics and Clinical Immunology Registry3 years

    Establish a bioregistry of patients receiving biologic therapy as part of their standard treatment at the Mount Sinai Therapeutic Infusion Center and affiliated practices. The approach is twofold. The first component is to establish a robust and flexible biorepository and database that includes demographic, immunologic, exposure and clinical records, and can facilitate research across disciplines, and across other registries affiliated with Mount Sinai. The second component is to address specific key research questions focused on using novel diagnostics to increase the effectiveness of biologic treatment.