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

October 14, 2015 updated by: John F. Foley, MD, Rocky Mountain MS Research Group, LLC

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 participants with relapsing remitting multiple sclerosis crossing over from natalizumab to dimethyl fumarate (DMF) therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Relapsing Remitting MS (RRMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Stability
Time Frame: 8 Months
Disease stability as measured by stable Expanded Disability Status Scale (EDSS) and no significant changes on magnetic resonance imaging lesions or relapses.
8 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify disease stability
Time Frame: 8 months
Disease stability will also be assessed by examining annualized relapse rate, proportion of patients experience relapses, Visual Analog Scale (VAS), Modified Fatigue Impact Scale (MFIS), Symbol Digit Modalities Test (SDMT) and pharmacodynamic and pharmacokinetic blood markers.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rocky Mountain MS Research Group, LLC

Collaborators

Biogen

Investigators

  • Principal Investigator: John F Foley, MD, President, Rocky Mountain MS Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 006-001-TEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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