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Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design — IIT6  

Relapsing Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial 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 Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Relapsing Remitting Multiple Sclerosis
Clinical Trial Details
NCT number NCT01945359
Study type Observational
Source Rocky Mountain MS Research Group, LLC
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date June 2015
View Details
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