- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085318
Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
January 25, 2018 updated by: EMD Serono
A Twenty-four Week, Two Arm, Pilot Trial to Evaluate Remyelination/ Demyelination, Gray Matter Volume and Iron Deposition in the Central Nervous System (CNS) and Immune Status of Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) Treated With Rebif® 44 mcg Subcutaneously (sc) Three Times a Week (Tiw) Compared to a Healthy Control Group
The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central nervous system (CNS) iron deposition, and d) immune status in subjects with relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Rockland, Massachusetts, United States, 02370
- EMD Serono, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
- RRMS diagnosed according to the McDonald criteria, treatment naïve or currently using any of the FDA-approved DMDs (excluding natalizumab (Tysabri®), mitoxantrone or Rebif®)
- Have a disease duration of up to twenty years
- Be willing and able to comply with the study procedures for the duration of the trial
- Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:
The following inclusion criteria must be fulfilled by the Healthy Control subjects:
- Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
- Be willing and able to comply with the study procedures for the duration of the trial
- Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:
Exclusion Criteria:
- Have received treatment within three months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis
- Have received treatment within thirty days prior to screening with immunosuppressant agents (e.g. including but not limited to mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation) or any other concomitant immunomodulatory therapies (e.g., azathioprine, methotrexate, CellCept®, natalizumab, alemtuzumab/Campath and other immunomodulators/monoclonal agents)
- Have had a relapse within thirty days prior to the Screening Visit
- Have received steroid treatment within thirty days prior to the initial MRI scan date at Study Day 1
- Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 1.5x ULN
- Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L
- Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
- Have a history of alcohol or drug abuse
- Have thyroid dysfunction
- Have moderate to severe renal impairment
- Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- Have a history of seizures not adequately controlled by treatment
- Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
- Have, in the opinion of the investigator, any visual, physical or cognitive impairment that would preclude the subject from complying with the study protocol
- Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
- Have received an investigational drug or experimental procedure within the past thirty days
- Are pregnant or attempting to conceive
The following exclusion criteria must be fulfilled by the Healthy Control subjects:
1. Have met any of the above noted criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1 MS Patients
Rebif 44 tiw
|
44 mcg tiw
|
No Intervention: Arm 2 Healthy Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months
Time Frame: Baseline to Month 6
|
To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).
|
Baseline to Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months
Time Frame: Baseline to Month 6
|
To characterize the effect of Rebif on demyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).
|
Baseline to Month 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Relapses
Time Frame: Over 6 months
|
Clinical Relapses
|
Over 6 months
|
Time to First Clinical Relapse
Time Frame: Months
|
Time to First Clinical Relapse
|
Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, Hayward B, Dangond F, Markovic-Plese S. Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial. BMC Neurol. 2015 Nov 11;15:232. doi: 10.1186/s12883-015-0488-9.
- Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, Weinstock-Guttman B. Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study. PLoS One. 2014 Mar 13;9(3):e91098. doi: 10.1371/journal.pone.0091098. eCollection 2014.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2010
Primary Completion (Actual)
February 29, 2012
Study Completion (Actual)
March 31, 2012
Study Registration Dates
First Submitted
March 10, 2010
First Submitted That Met QC Criteria
March 10, 2010
First Posted (Estimate)
March 11, 2010
Study Record Updates
Last Update Posted (Actual)
February 23, 2018
Last Update Submitted That Met QC Criteria
January 25, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29665
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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