Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | June 2015 |
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.
switching therapies from natalizumab to dimethyl fumarate to determine disease stability.
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.
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.
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
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