NCT01906684

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

July 19, 2013

Last Update Submit

July 31, 2013

Conditions

Multiple Sclerosis

Keywords

Acthar GelMS relapse7T MRI imagingQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Acthar Gel

EXPERIMENTAL

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

Interventions

Acthar GelDRUG

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.

Acthar Gel

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanner Center for MS

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Emily S Riser, MD

    Tanner Center for MS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ritalinda D Lee, PhD

CONTACT

256-714-0683rlee@tannerms.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 24, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations

US(1)