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Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design

Information source: Rocky Mountain MS Research Group, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Phase: N/A

Status: Active, not recruiting

Sponsored by: Rocky Mountain MS Research Group, LLC

Official(s) and/or principal investigator(s):
John F Foley, MD, Principal Investigator, Affiliation: President, Rocky Mountain MS Research Group

Summary

This study will observe participants with relapsing remitting multiple sclerosis who are switching therapies from natalizumab to dimethyl fumarate to determine disease stability.

Clinical Details

Official title: A Pilot Study to Assess Disease State Stability, Efficacy, and Tolerability in a Natalizumab to Dimethyl Fumarate Crossover Design

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Disease Stability

Secondary outcome: Quantify disease stability

Detailed description: This is an investigator initiated, single site, open-label, single arm observational study examining the initial efficacy and tolerability of dimethyl fumarate in a real world clinical setting for patients with a relapsing form of Multiple Sclerosis (MS) when crossed over from natalizumab therapy. The decision to cross over from natalizumab to DMF will be made by the patient and the prescribing physician and must precede enrollment in the study. MS disease status and history will be gathered from the patient's medical records. Patients will be followed for the first 24 weeks of their transition from natalizumab. Assessments will be performed at Baseline and every 4 weeks thereafter for 24 weeks. These assessments may include:

- Expanded Disability Status Scale (EDSS)

- Relapse Assessment

- Patient Reported Outcomes (PRO) including quality of life, fatigue, and cognition

outcome measures

- Magnetic Resonance Imaging (MRI)

- Laboratory testing

Study drop outs due to DMF intolerability or other etiologies will be encouraged to complete the trial even if placed on alternative therapies.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. JCV Indec of 1. 5 of greater and currently receiving natalizumab therapy for at least 24 months 2. Decision to treat with DMF must precede enrollment 3. Ability to understand the purpose and risk of the study and provide authorization for the use of protected health information in accordance with the monitoring agency 4. Men or women >= 18 years at time of informed consent 5. Naive to DMF or fumaric acid esters 6. Confirmed diagnosis of a relapsing form of MS as verified by their treating physician Exclusion Criteria: 1. Inability ot comply with study requirements as outlined in the informed consent 2. Known active malignancies or any other major co morbidity that, in the opinion of the Investigator, would affect the outcome of the study 3. Pregnancy or breastfeeding 4. Previous treatment with dimethyl fumarate

Locations and Contacts

Rocky Mountain MS Research Group, Salt Lake City, Utah 84103, United States
Additional Information

Starting date: September 2013
Last updated: May 6, 2015

Page last updated: August 23, 2015

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