NCT04789551

Brief Summary

The goal of this research study is to to learn more about the body's immune response in patients with multiple sclerosis (MS). In MS, the body's immune cells mistakenly attack an important part of the nerves of the brain and spinal cord. The immune cells responsible for attacking the nerves in MS patients is primarily the T cells. A marker was recently discovered that might specifically identify these damaging T cells from all other T cells in the body. Understanding which T cells cause the damage in MS patients and understanding more about these specific T cells may help doctors better understand how MS occurs and could possibly prevent MS in the future.

Trial Health

50
Monitor

Trial Health Score

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

Timeline
4mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Progress67%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
4.7 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 2, 2026

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

March 5, 2021

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • T cell populations

    compare T cell populations between patients with Multiple Sclerosis and healthy controls

    up to one week

Study Arms (3)

Multiple Sclerosis Stable Conditions

Multiple sclerosis patients presenting for a routine clinic visit.

Other: Blood Sample

Multiple Sclerosis Acute Flare Up

Multiple sclerosis patients admitted to the hospital with acute symptoms.

Other: Blood Sample

Control patients

Patients without any immunological diseases who present for elective surgery.

Other: Blood Sample

Interventions

a blood sample will be collected

Control patientsMultiple Sclerosis Acute Flare UpMultiple Sclerosis Stable Conditions

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Multiple Sclerosis who present to Boston Children's Hospital will be enrolled. A group of healthy control patients who present for elective surgery at Boston Children's Hospital will also be enrolled.

You may qualify if:

  • diagnosis of multiple sclerosis and present to the neurology clinic for a regular checkup or are admitted to the inpatient floor with acute symptoms.

You may not qualify if:

  • Have an active infection
  • Take T cell modulating drugs
  • Have an active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hopsital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

December 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 2, 2026

Record last verified: 2025-11

Locations