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

NCT01085318 | Completed Phase 4 Results

• 1 other identifier: 29665
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  Baseline to Month 6

Other Outcomes (2)

• Clinical Relapses

  Over 6 months

• Time to First Clinical Relapse

  Months

Study Arms (2)

Arm 1 MS Patients

ACTIVE COMPARATOR

Rebif 44 tiw

Drug: Rebif

Arm 2 Healthy Control

NO INTERVENTION

Interventions

Rebif DRUG

44 mcg tiw

Arm 1 MS Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

EMD Serono, Inc.

Rockland, Massachusetts, 02370, United States

Location

Related 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 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.

  PMID: 26559139 RESULT

• 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.

  PMID: 24625687 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Fernando Dangond, MD FAAN
• Organization: EMD Serono, Inc.

fernando.dangond@emdserono.com

781-681-2348

Study Officials

• Fernando Dangond, MD

  EMD Serono

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: June 30, 2010
• Primary Completion: February 29, 2012
• Study Completion: March 31, 2012
• Last Updated: February 23, 2018
• Results First Posted: May 3, 2013

Record last verified: 2018-01

Locations

US (1)