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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01945359

Acronym

IIT6

Enrollment

Registered

2013-09-18

Start date

2013-09-30

Completion date

2015-06-30

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis, Dimethyl Fumarate, Natalizumab

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Quantify disease stability	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.

Countries

United States

Outcome results