Comprehensive Analysis of Relapse in Multiple Sclerosis

This study will determine changes in: 1) the immune activity, characterized as the "immunorepertoire;" 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who are treated with Acthar Gel.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Acthar Gel

Detailed Description

20 patients with documented Multiple Sclerosis, who have been diagnosed within 12 months of enrollment in the study and who are currently experiencing an MS relapse, defined as the following manifestation:

Acute onset or worsening of any of the manifestations of CNS relapses (excluding spinal cord) including:

• Brain stem syndrome
• Optic neuritis
• Cerebellar syndromes

If they choose to participate, subjects will be asked to:

Meet at the Clinic 4 times:

• Initial visit
• 5 days after baseline visit
• 14 days after baseline visit
• 30 days after baseline visit

Meet with neurologist for neurological exam that will include a:

• Review of neurological status
• Review of new and ongoing symptoms
• Review of symptom resolution
• Review of any side effects or adverse events
• Resolution of any patient questions and concerns
• Provide a 40cc whole blood sample

At each of the 4 visits

• Consent to Acthar Gel treatment for their relapse for 14 days (or as required for their relapse)
• Ss will agree to be trained in self-administration of Acthar
• First dose administered at Baseline visit
• Self-administered days 2-14 of participation
• Complete 4 psychometric instruments

At baseline and 30 day visit

• Cognitive assessment using the Brief International Cognitive Assessment for MS (Benedict 2012)
• Administered by Tanner Center Staff specially trained in this assessment
• Quality of Life assessments: self-administered
• MSQoL (Cella et al, 1006)
• Psychological Adjustment to Illness Survey (Rodrigue et al 2000)
• Coping Skills Inventory (Liveneh, 2003)
• Participate in a brief semi-structured interview, at Day 5 visit

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Tanner Center for MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients will be eligible to participate in the study if:

They were diagnosed with Relapsing-Remitting Multiple Sclerosis within 1 year of their participation in the study Are established patients of the Tanner Center for MS Seek care for relapse within 72 hours of onset Are between the ages of 19 and 65 inclusively.

Relapse will be confirmed and defined as the acute worsening of function that lasts for at least 24 hours with any of the manifestations of Central Nervous System relapses (excluding spinal cord) including:

Brain stem syndrome Optic neuritis Cerebellar syndromes Hemi-motor/sensory events Males and Females are both eligible Patients of any race or ethnicity are eligible Are not pregnant (as confirmed by pregnancy test at the time of enrollment) or nursing Have no known contraindicating conditions (see exclusions)

Exclusion Criteria:

• Potential participants will be excluded if they do not meet the above criteria, and also if:

They are currently being treated for MS with the any of the following disease-modifying drugs: Tysabri, Gilenya, Aubagio, Tecfidera They have a history of experiencing significant adverse reactions to corticosteroids They are deemed by Dr Riser to be better served with an intervention other than Acthar Gel to treat their current MS relapse Are pregnant or nursing

Are known to have any of the contraindicating conditions:

Scleroderm Osteoporosis Systemic fungal infections Ocular herpes simplex Recent surgery History of or presence of peptic ulcer Congestive heart failure Uncontrolled hypertension Adreno-cortical insufficiency, hyper-function or sensitivity Sensitivity to proteins of porcine origin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acthar Gel; Acthar Gel is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection). Acthar Gel will be administered as a subcutaneous daily dose of 80 units for up to 2 weeks.	Drug: Acthar Gel; Patients who present with MS relapse within 72 hours of onset will be recruited for study. Upon consent they will be administered Achtar Gel for 5-14 days as clinically appropriate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life	This study will observe changes in the activity of b cells and t cells as evidenced in the patient's immunorepertoire, as well as changes in 7T MRI images, physician-documented clinical outcomes in patients receiving Acthar Gel for treatment of MS relapse at four time points: baseline, 5, 14 and 30 days post initiation of treatment.	within 1 month post initiation of treatment with Acthar Gel

Collaborators and Investigators

• Sponsor: Tanner Foundation for Multiple Sclerosis
• Collaborators: Mallinckrodt; Auburn University MRI Research Center; iReportoire Inc
• Investigators: Principal Investigator: Emily S Riser, MD, Tanner Center for MS

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ANTICIPATED): January 1, 2014
• Study Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (ESTIMATE): July 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 1, 2013
• Last Update Submitted That Met QC Criteria: July 31, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Quality of Life; Acthar Gel; MS relapse; 7T MRI imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Multiple Sclerosis; Sclerosis; Recurrence
• Other Study ID Numbers: TFMS:QP1-2013