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VALIDATE: Factor VIII Trending for MS Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082468
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary:
Multiple sclerosis (MS) patients hospitalized with an acute motor or visual relapse will be consented. Factor VIII-related labs will be systematically drawn for six months. During this time, patients will be followed with clinical assessments including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), Low Contrast Sloan Letter Chart Testing, Symbol Digital Modality Test (SDMT), and NeuroQol. MRIs of the brain, cervical spine, and thoracic spine with and without contrast will be obtained. All patients will be treated with 1 gram IV solumedrol daily for five days per standard care. 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 intravenous (IV) solumedrol treatment

Condition or disease Intervention/treatment
Multiple Sclerosis Diagnostic Test: Blood sample collection for coagulation profile

Detailed Description:

The identification of blood tests that detect patients having Multiple Sclerosis (MS) relapses in real time could lead to a new era of MS relapse treatment. Accidental, anecdotal clinical observations suggest that transient upregulation of the intrinsic coagulation pathway, namely with elevated von Willebrand Factor antigen levels (vWF) and increased Factor VIII activity, occur with some MS relapses and that the higher the elevated plasma values, the more glucocorticoid therapy required to achieve clinical improvement.

Ten adult patients with relapsing remitting MS with or without secondary progression will be consented and enrolled in this longitudinal clinical trial. As a standard of care all patients will be treated daily with one gram IV solumedrol for five days, and all patients will have performed standard MRI's of the brain, cervical spine, and thoracic spine with and without IV contrast during hospital admission, which may occur after Solumedrol treatment.

In addition to this standard of care, patients will have a panel of labs drawn on Days: 1 (prior to any solumedrol treatment), 7, 15, 30, 45, 60, 90, 135, and 180. Neurological clinical assessments, comprising of assessing the EDSS score, the MSFC index (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), LCSLC test, SDMT, and Neuro QoL will be conducted on Days: 1, 7, 30, 90, 180. Individual and aggregate laboratory values, neurological clinical assessment results, and MRI findings will be correlated for the presence of a MS relapse, severity of relapse, and extent of recovery from the relapse. Patients and evaluators will be blinded to the lab results.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Trial Evaluating Whether Elevated Factor VIII Activity During Multiple Sclerosis Relapses Serves as a Marker for Solumedrol-Resistance and Incomplete Relapse Recovery
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2022



Intervention Details:
  • Diagnostic Test: Blood sample collection for coagulation profile
    Factor VIII Activity Level, Factor VIII Antigen Level, Interleukin 6, vWF Antigen Level, Thrombin Activity, Protein C Activity, Protein C Antigen Level, CRP, PT/PTT/INR ,T & B lymphocyte panel at above time points
    Other Name: Clinical data collection


Primary Outcome Measures :
  1. Correlation of MS relapse recovery time with elevated lab values. [ Time Frame: 180 days ]
    Extent of relapse recovery across a variety of measures will be correlated with collected lab values and neurological assessments in an attempt to identify a positive correlation between incomplete recovery and solumedrol resistance with abnormally elevated lab values involving the vWF antigen and Factor VIII pathways



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute MS relapse patients hospitalized at St. Joseph's Hospital and Medical Center in Phoenix, Arizona
Criteria

Inclusion Criteria:

  1. Adult patients aged 18-65 with an established diagnosis of relapsing remitting multiple sclerosis (RRMS);
  2. Patients with RRMS hospitalized at St. Joseph's Hospital and Medical Center in Phoenix, Arizona for an acute relapse affecting strength or vision;
  3. Patients may or may not be on disease modifying treatment;
  4. Entry EDSS score up to 7.0.

Exclusion Criteria:

  1. Patients unable to have an MRI;
  2. Patients taking any heparin products, warfarin (Coumadin), apixiban (Eliquis), dabigatran (Pradaxa), or rivaroxaban (Xarelto);
  3. If stroke, tumor or other non-MS related cause is identified as the source of the patient's neurological issues.

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): NCT04082468


Contacts
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Contact: Mary Thornton, RN 602-406-6287 mary.thornton@dignityhealth.org
Contact: Stacey Lent 602-406-6291 Stacey.lent@dignityhealth.org

Locations
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United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Mary Thornton, RN    602-406-6287    mary.thornton@dignityhealth.org   
Contact: Stacy Lent    602-406-6291    Stacey.lent@dignityhealth.org   
Principal Investigator: Aimee Borazanci, MD         
Sub-Investigator: Dolly Roy, MD, PhD         
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
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Principal Investigator: Amiee Borazanci, MD St. Joseph's Hospital/Barrow Neurological Institute

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Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT04082468    
Other Study ID Numbers: 18-500-440-30-10
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 St. Joseph's Hospital and Medical Center, Phoenix:
Relapsing remitting Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Factor VIII
Coagulants