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

NCT ID: NCT01085318

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-03-31

Brief 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1 MS Patients

Rebif 44 tiw

Group Type: ACTIVE_COMPARATOR

Rebif

Intervention Type: DRUG

44 mcg tiw

Arm 2 Healthy Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rebif

44 mcg tiw

Intervention Type: DRUG

Eligibility 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:

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

1. Have met any of the above noted criteria

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Dangond, MD

Role: STUDY_DIRECTOR

EMD Serono

Locations

EMD Serono, Inc.

Rockland, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 26559139 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24625687 (View on PubMed)

Other Identifiers

29665

Identifier Type: -

Identifier Source: org_study_id