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

NCT ID: NCT05077956

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2023-10-25

Brief 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).

Detailed 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.

Conditions

Relapsing Multiple Sclerosis; Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Recently Diagnosed Multiple Sclerosis

Recently diagnosed MS, who 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 (DMT).

Cerebrospinal and Blood Serum Semaphorin 4A Levels

Intervention Type: DIAGNOSTIC_TEST

Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.

Clinically Stable Relapsing Multiple Sclerosis

Clinically stable relapsing MS, who are receiving a FDA-approved MS DMT and have had no evidence of a clinical relapse for at least the past 12 weeks or gadolinium enhancing lesions on MRI in the prior 4 weeks.

Cerebrospinal and Blood Serum Semaphorin 4A Levels

Intervention Type: DIAGNOSTIC_TEST

Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.

Relapsing Multiple Sclerosis on Disease Modifying Therapy

Relapsing MS on a FDA-approved DMT with evidence of recent breakthrough disease, with a documented clinical relapse and/or gadolinium-enhancing lesion(s) on brain or spinal cord MRI taken within the 4 weeks.

Cerebrospinal and Blood Serum Semaphorin 4A Levels

Intervention Type: DIAGNOSTIC_TEST

Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.

Healthy Volunteers

Patients 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.

Cerebrospinal and Blood Serum Semaphorin 4A Levels

Intervention Type: DIAGNOSTIC_TEST

Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.

Interventions

Cerebrospinal and Blood Serum Semaphorin 4A Levels

Cerebrospinal fluid and serum will be collected at baseline to measure the level of semaphorin 4A.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley Cohan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Providence Health and Services

Locations

Providence St. Vincent Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

2021000250

Identifier Type: -

Identifier Source: org_study_id