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Observational Trial Evaluating Elevated Factor VIII Related Labs as a Biomarker for Incomplete Relapse Recovery

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ClinicalTrials.gov Identifier: NCT05926167
Recruitment Status : Not yet recruiting
First Posted : July 3, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
Dignity Health Medical Foundation

Study Description
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Brief Summary:
Nine Multiple Sclerosis (MS) patients suffering an acute relapse from the outpatient or inpatient settings will be consented to be followed prospectively for three months post relapse, in an effort to identify markers of incomplete relapse recovery. Factor VIII-related labs will be drawn for three months without influencing standard of care treatment decisions. During this time, patients will be followed with clinical and diagnostic assessments in addition to blood tests including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), recovery surveys, and MRIs of the brain, cervical spine, and thoracic spine with and without contrast. Clinical, imaging, and Factor VIII-related lab data individually or in aggregate will be correlated with relapse presence, severity, and extent of recovery following standard treatment interventions.

Condition or disease Intervention/treatment
Multiple Sclerosis Relapse Diagnostic Test: blood tests drawn days 1, 8, 22 and 90 of the study

Detailed Description:

The identification of blood tests that detect patients having disability provoking Multiple Sclerosis (MS) relapses in real time could lead to a new era of MS relapse treatment. The cross-talk between inflammatory and coagulation pathways in multiple sclerosis has been recognized on some level for decades. Accidental and anecdotal clinical observations suggest that excessive activation of the intrinsic coagulation pathway, namely with increased Factor VIII activity, occurs with some MS relapses, and that these are the relapses that don't recover with current standard of care treatments, leaving behind permanent disability.

To test this hypothesis that real time abnormally increased levels of Factor VIII activity related labs can identify disabling relapses in real time, nine adult patients with relapsing remitting MS with or without secondary progression will be consented and enrolled in this observational, longitudinal clinical trial. Patients will receive standard of care treatment per the investigator's discretion for their relapse, but will have additional blood tests testing Factor VIII activity, Factor VIII antigen, serum neurofilament among others drawn on days 1, 8, 22 and 90 of the study. The investigator and the patient will not know these lab test results. Patients will also have mris of the brain, cervical spine, and thoracic spine done with and without contrast as soon as possible upon study entry. On Days 1,8,22, and 90, in addition to blood tests, the patient will complete an EDSS and MSFC (that looks at ambulation, hand/arm coordination, and cognitive function, comprised of the 25 foot timed walking tests, with and without any assistive devices if possible), and fill out a recovery survey. Individual blood tests, aggregate blood tests, mri findings, EDSS and MSFC individual and summed scores will be scrutinized and evaluated for the ability to identify a MS relapse and to identify a treatment-resistant MS relapse

Study Design
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Study Type : Observational
Estimated Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: VALIDATE II Study: Observational Trial Evaluating Elevated Factor VIII Related Labs in Multiple Sclerosis Relapse as a Marker for Incomplete Recovery
Estimated Study Start Date : September 12, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: blood tests drawn days 1, 8, 22 and 90 of the study
    Blood tests related to Factor VIII activity that are not a part of standard of care

Outcome Measures
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Primary Outcome Measures :
  1. Correlation of Factor VIII activity, Factor VIII with MS relapse [ Time Frame: 90 days ]
  2. Correlation of Factor VIII activity, Factor VIII antigen with MS relapse incomplete recovery [ Time Frame: 90 days ]
  3. Correlation of additional labs with MS relapse or MS relapse incomplete recovery [ Time Frame: 90 days ]
  4. Correlation of MRI findings with MS relapse and MS relapse recovery [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult relapsing remitting patients with an established or new diagnosis of relapsing remitting multiple sclerosis suffering an acute MS relapse. Patients can be on any disease modifying therapy or on no therapy. Patients who cannot have a MRI, found to have an alternative neurological explanation for their symptoms will be excluded. Patients will be enrolled from a Multiple Sclerosis clinic or from an inpatient hospital setting.
Criteria

Inclusion Criteria: Identified by prinicipal investigator as having an acute multiple sclerosis relapse of less than 30 days duration

-

Exclusion Criteria:

Inability to have a MRI

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05926167


Contacts
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Contact: Dolly B Roy, MD PhD 9165362048 dollybroy@yahoo.com
Contact: Lucy Ng 9165362048 cshri-irb@commonspirit.org

Sponsors and Collaborators
Dignity Health Medical Foundation
Investigators
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Principal Investigator: Sabeen B Lulu, MD Dignity Health Medical Foundation
More Information
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Responsible Party: Dignity Health Medical Foundation
ClinicalTrials.gov Identifier: NCT05926167    
Other Study ID Numbers: Validate II
First Posted: July 3, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dignity Health Medical Foundation:
multiple sclerosis relapse biomarker
Factor VIII
Additional relevant MeSH terms:
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Multiple Sclerosis
Hemophilia A
Sclerosis
Recurrence
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Disease Attributes
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn