Recruiting

Biologics

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT04784364

Conditions

Immunological Disease

Autoimmune Diseases

Primary Immune Deficiency

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The study team plans to 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 study team will to apply state-of-the-art approaches to assessing and predicting immunological and clinical responses associated with these standards and prescribed treatments. 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. Most patients will be recruited from the Mount Sinai Therapeutic Infusion Center (TIC), although others receiving infusions elsewhere or at home will be recruited from outpatient Sinai affiliated clinical practices.

Conditions

Immunological Disease

Autoimmune Diseases

Primary Immune Deficiency

Study ID

NCT04784364

Start date

Mar 3, 2021

Status verified date

Feb, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Biologics and Clinical Immunology Registry [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Rachel Miller

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Asthma
  • Immune Deficiency
  • Autoimmunity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-17.