WithdrawnN/AOther

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

Sponsored by Providence Health & Services

NCT ID
NCT05077956
Start Date
2021-10-19
Est. Completion
2023-10-25

About This Study

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 Studied

Relapsing Multiple SclerosisMultiple Sclerosis

Interventions

  • Cerebrospinal and Blood Serum Semaphorin 4A Levels

Eligibility

Sex:FEMALE
Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full 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

Exclusion Criteria:

* There are no exclusion criteria for this study.

Study Locations (1)

Providence St. Vincent Medical Center
Portland, Oregon, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source