Pilot Study to Assess Disease Stability in a Natalizumab... | NCT01945359

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

NCT01945359

Sponsor

Rocky Mountain MS Research Group, LLC

Status

Completed

Last Update Posted

Oct 16, 2015Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Jun 2015Actual

First Submitted Date

Sep 13, 2013

First Submission Date that Met QC Criteria

Sep 13, 2013

First Posted Date

Sep 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Name	Class
Biogen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Label	Type	Description	Intervention Names
Relapsing Remitting MS (RRMS)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John F Foley, MD	President, Rocky Mountain MS Research Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rocky Mountain MS Research Group		Salt Lake City	Utah	84103	United States

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

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Browse Branches

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