Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— Sema4A MS  

Official title:

Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05077956
• Other study ID #: 2021000250
• Status: Withdrawn
• Start date: October 19, 2021
• Est. completion date: October 25, 2023

Study information

• Verified date: August 2023
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).

Description:

This pilot study proposal will further investigate whether Semaphorin 4A (Sema4A) elevation in cerebrospinal fluid (CSF) and serum is a potential disease activity biomarker in patients with multiple sclerosis (MS). A total of 40 female subjects between the ages of 18-55 who meet the criteria of one of the following four groups will be enrolled to measure serum and CSF Sema4A levels: - Group 1: Newly diagnosed/untreated Relapsing MS patients (RMS) - Group 2: Clinically stable RMS patients receiving disease modifying therapy (DMT) - Group 3: RMS patients receiving DMT with breakthrough disease - Group 4: Non-MS controls (patients without inflammatory CNS disease) Participants will provide blood and CSF samples at baseline for Sema4A analysis. Follow up blood samples will be collected at 6 months and 12 months as part of lymphocyte subset analysis. Participation will end after 12 months of follow up. The expected risks are related to blood draws and lumbar puncture. Lumbar puncture will be performed under fluoroscopy to decrease risks of pain from repeated needle punctures, injury from incorrect placement of the needle, and post puncture CSF leakage.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 25, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Female aged 18-55, inclusive at the time of consent
• Not pregnant at the time of the screening/baseline visit
• Able to understand the purpose, benefits, and risks of the study; willing and able to adhere to the study requirements; able and provide informed consent in English
• Meet the criteria of one of the four groups at the time of consent:
• Group 1: subjects who have recently been diagnosed with MS, have had a clinical attack within the last 6 months, have not received steroids in the last 30 days, and have not started on a disease modifying therapy
• Group 2: subjects with clinically stable relapsing MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks, who are receiving a FDA-approved MS DMT
• Group 3: subjects with relapsing MS on a FDA-approved DMT but with evidence of breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks
• Group 4: subjects without evidence of inflammatory systemic or CNS disease, who require CSF removal for some other cause, such as for idiopathic intracranial hypertension or communicating hydrocephalus

Exclusion Criteria:

• There are no exclusion criteria for this study.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Cerebrospinal and Blood Serum Semaphorin 4A Levels
Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.

Locations

Country	Name	City	State
United States	Providence St. Vincent Medical Center	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Providence Health & Services	Bristol-Myers Squibb, Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Serum Semaphorin 4A Levels	Measure blood serum semaphorin 4A levels at baseline	Baseline
Primary	Cerebrospinal Fluid Semaphorin 4A Levels	Measure cerebrospinal fluid semaphorin 4A levels at baseline	Baseline
Secondary	Correlation between Semaphorin 4A levels and Demyelination and Axonal Degeneration	MRI will be performed at 6 months and 12 months to evaluate if there is a correlation between baseline semaphorin 4 A levels and demyelination and axonal degeneration.	12 Months