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

Relapsing Remitting Multiple Sclerosis Clinical Trial

— IIT6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945359
• Other study ID #: 006-001-TEC
• Status: Completed
• Phase: N/A
• First received: September 13, 2013
• Last updated: October 14, 2015
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Rocky Mountain MS Research Group, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis

Locations

Country	Name	City	State
United States	Rocky Mountain MS Research Group	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Rocky Mountain MS Research Group, LLC	Biogen

Country where clinical trial is conducted

United States, 

Outcome

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