Clinical trial NCT01945359: Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
Official title: A Pilot Study to Assess Disease State Stability, Efficacy, and Tolerability in a Natalizumab to Dimethyl Fumarate Crossover Design
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis
Dimethyl Fumarate
Natalizumab
Lead sponsor: Rocky Mountain MS Research Group, LLC
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2013-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 participants with relapsing remitting multiple sclerosis crossing over from natalizumab to dimethyl fumarate (DMF) therapy

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.

Eligibility 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

Primary outcomes:
measure: Disease Stability
timeFrame: 8 Months
Secondary outcomes:
measure: Quantify disease stability
timeFrame: 8 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Rocky Mountain MS Research Group
state: Utah
Study officials:
affiliation: President, Rocky Mountain MS Research Group
name: John F Foley, MD
role: PRINCIPAL_INVESTIGATOR
References: