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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085318
• Other study ID #: 29665
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2010
• Last updated: January 25, 2018
• Start date: June 30, 2010
• Est. completion date: March 31, 2012

Study information

• Verified date: January 2018
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 31, 2012
• Est. primary completion date: February 29, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Rebif
44 mcg tiw

Locations

Country	Name	City	State
United States	EMD Serono, Inc.	Rockland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 treat — View Citation

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 appe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Relapses	Clinical Relapses	Over 6 months
Other	Time to First Clinical Relapse	Time to First Clinical Relapse	Months
Primary	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	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	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	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