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

NCT05077956 | Withdrawn DMC

• 1 other identifier: 2021000250
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Relapsing Multiple Sclerosis; Multiple Sclerosis

Keywords

multiple sclerosis; relapsing multiple sclerosis; semaphorin 4A; sema4a; disease modifying therapy; biomarker

Outcome Measures

Primary Outcomes (2)

• Blood Serum Semaphorin 4A Levels

  Measure blood serum semaphorin 4A levels at baseline

  Baseline

• Cerebrospinal Fluid Semaphorin 4A Levels

  Measure cerebrospinal fluid semaphorin 4A levels at baseline

  Baseline

Secondary Outcomes (1)

• Correlation between Semaphorin 4A levels and Demyelination and Axonal Degeneration

  12 Months

Study Arms (4)

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).

Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels

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.

Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels

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.

Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels

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.

Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels

Interventions

Cerebrospinal and Blood Serum Semaphorin 4A Levels DIAGNOSTIC_TEST

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

Clinically Stable Relapsing Multiple Sclerosis; Healthy Volunteers; Recently Diagnosed Multiple Sclerosis; Relapsing Multiple Sclerosis on Disease Modifying Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Multiple sclerosis and non-MS controls

You may qualify if:

• 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

Sponsors & Collaborators

• Providence Health & Services: lead
• Milton S. Hershey Medical Center: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sema4A is measured in serum and CSF by a Sema-4A-specific ELISA (Biomatik). Frozen serum and CSF samples will be sent to laboratory at Penn State for these measurements. Whole blood and CSF will be obtained from each subject at the screening/baseline visit, with follow-up whole blood at 6 and 12 months in patient Groups 1-3. We will also measure myelin basic protein levels in the CSF and measure lymphocyte subsets in whole blood for Groups 1-3. These two tests will be performed by the Providence clinical lab.

MeSH Terms

Conditions

Multiple Sclerosis; Cone-Rod Dystrophy 10

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stanley Cohan, MD, PhD

  Providence Health and Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: October 19, 2021
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

US (1)