Relapsing Remitting Multiple SclerosisIIT6NCT01945359
Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
An observational study of Relapsing Remitting Multiple Sclerosis, run by Rocky Mountain MS Research Group, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 participants with relapsing remitting multiple sclerosis crossing over from natalizumab to dimethyl fumarate (DMF) therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain MS Research Group
Salt Lake City, Utah, 84103
About this study
Official title: 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.
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Relapsing Multiple Sclerosis, Dimethyl Fumarate, Natalizumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Relapsing Remitting MS (RRMS) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Stability
Disease stability as measured by stable Expanded Disability Status Scale (EDSS) and no significant changes on magnetic resonance imaging lesions or relapses.
Measured: 8 Months
Secondary outcomes (1)
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain MS Research Group, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Principal investigator, John F. Foley, MD, Rocky Mountain MS Research Group, LLC
- Investigators
- John F Foley, MD, Principal investigator, President, Rocky Mountain MS Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945359
- Sponsor's protocol ID
- 006-001-TEC
- Acronym
- IIT6
- Status last verified
- Oct 2015
- First submitted
- 13 Sep 2013
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Disease State Stability, Efficacy, and Tolerability in a Natalizumab to Dimethyl Fumarate Crossover Design
- ClinicalTrials.gov ID
- NCT01945359
- Acronym / sponsor ID
- IIT6 / 006-001-TEC
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Relapsing Multiple Sclerosis, Dimethyl Fumarate, Natalizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rocky Mountain MS Research Group, LLCUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing Remitting MS (RRMS) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 participants with relapsing remitting multiple sclerosis crossing over from natalizumab to dimethyl fumarate (DMF) therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Stability
Time frame: 8 Months
Disease stability as measured by stable Expanded Disability Status Scale (EDSS) and no significant changes on magnetic resonance imaging lesions or relapses.
1 secondary outcome
Quantify disease stability
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Foley, MD principal investigator
President, Rocky Mountain MS Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Rocky Mountain MS Research Group, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Stability (time frame: 8 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.