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

NCT05926167 | Unknown

• 1 other identifier: Validate II
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis; Relapse

Keywords

multiple sclerosis relapse biomarker; Factor VIII

Outcome Measures

Primary Outcomes (4)

• Correlation of Factor VIII activity, Factor VIII with MS relapse

  90 days

• Correlation of Factor VIII activity, Factor VIII antigen with MS relapse incomplete recovery

  90 days

• Correlation of additional labs with MS relapse or MS relapse incomplete recovery

  90 days

• Correlation of MRI findings with MS relapse and MS relapse recovery

  90 days

Interventions

blood tests drawn days 1, 8, 22 and 90 of the study DIAGNOSTIC_TEST

Blood tests related to Factor VIII activity that are not a part of standard of care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• Inability to have a MRI

Sponsors & Collaborators

• Dignity Health Medical Foundation: lead

MeSH Terms

Conditions

Multiple Sclerosis; Recurrence; Hemophilia A

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sabeen B Lulu, MD

  Dignity Health Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dolly B Roy, MD PhD

CONTACT

9165362048; dollybroy@yahoo.com

Lucy Ng

CONTACT

9165362048; cshri-irb@commonspirit.org

Study Design

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

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: September 12, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09