Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01085318
First received: March 10, 2010
Last updated: August 2, 2013
Last verified: August 2013
  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:


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:

  1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
  2. RRMS diagnosed according to the McDonald criteria, treatment naïve or currently using any of the FDA-approved DMDs (excluding natalizumab (Tysabri®), mitoxantrone or Rebif®)
  3. Have a disease duration of up to twenty years
  4. Be willing and able to comply with the study procedures for the duration of the trial
  5. Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
  6. 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:

  1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
  2. Be willing and able to comply with the study procedures for the duration of the trial
  3. Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
  4. Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:

Exclusion Criteria:

  1. Have received treatment within three months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis
  2. 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)
  3. Have had a relapse within thirty days prior to the Screening Visit
  4. Have received steroid treatment within thirty days prior to the initial MRI scan date at Study Day 1
  5. 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
  6. Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L
  7. Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
  8. Have a history of alcohol or drug abuse
  9. Have thyroid dysfunction
  10. Have moderate to severe renal impairment
  11. 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
  12. Have a history of seizures not adequately controlled by treatment
  13. Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
  14. Have, in the opinion of the investigator, any visual, physical or cognitive impairment that would preclude the subject from complying with the study protocol
  15. Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
  16. Have received an investigational drug or experimental procedure within the past thirty days
  17. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085318

Locations
United States, Massachusetts
EMD Serono, Inc.
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Fernando Dangond, MD EMD Serono, Inc.
  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: August 2, 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 April 17, 2014