Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
This study has been completed.
Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01085318
First received: March 10, 2010
Last updated: May 6, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Rebif |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
Drug Information available for:
Interferon Beta-1a
U.S. FDA Resources
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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).
Other Outcome Measures:
- Clinical Relapses [ Time Frame: Over 6 months ] [ Designated as safety issue: Yes ]Clinical Relapses
- Time to First Clinical Relapse [ Time Frame: Months ] [ Designated as safety issue: Yes ]Time to First Clinical Relapse
| Enrollment: | 38 |
| Study Start Date: | June 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1 MS Patients
Rebif 44 tiw
|
Drug: Rebif
44 mcg tiw
|
| No Intervention: Arm 2 Healthy Control |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT01085318 History of Changes |
| Other Study ID Numbers: | 29665 |
| Study First Received: | March 10, 2010 |
| Results First Received: | February 11, 2013 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Interferon beta 1a Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013