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

NCT01945359 | Completed

• 1 other identifier: 006-001-TEC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis; Dimethyl Fumarate; Natalizumab

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quantify disease stability

  8 months

Study Arms (1)

Relapsing Remitting MS (RRMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• JCV Indec of 1.5 of greater and currently receiving natalizumab therapy for at least 24 months
• Decision to treat with DMF must precede enrollment
• 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
• Men or women \>= 18 years at time of informed consent
• Naive to DMF or fumaric acid esters
• Confirmed diagnosis of a relapsing form of MS as verified by their treating physician

You may not qualify if:

• Inability ot comply with study requirements as outlined in the informed consent
• Known active malignancies or any other major co morbidity that, in the opinion of the Investigator, would affect the outcome of the study
• Pregnancy or breastfeeding
• Previous treatment with dimethyl fumarate

Sponsors & Collaborators

• Rocky Mountain MS Research Group, LLC: lead
• Biogen: collaborator

Study Sites (1)

Rocky Mountain MS Research Group

Salt Lake City, Utah, 84103, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Samples

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John F Foley, MD

  President, Rocky Mountain MS Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Rocky Mountain MS Research Group

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

US (1)