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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 MS Patients | Active Comparator | Rebif 44 tiw |
|
| Arm 2 Healthy Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif | Drug | 44 mcg tiw |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Relapses | Clinical Relapses | Over 6 months |
| Time to First Clinical Relapse | Time to First Clinical Relapse | Months |
Inclusion Criteria:
The following inclusion criteria must be fulfilled by the Healthy Control subjects:
Exclusion Criteria:
The following exclusion criteria must be fulfilled by the Healthy Control subjects:
1. Have met any of the above noted criteria
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Dangond, MD | EMD Serono | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMD Serono, Inc. | Rockland | Massachusetts | 02370 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26559139 | Result | 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. | |
| 24625687 |
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Relapsing Remitting Multiple Sclerosis (RRMS)Participants could not have received treatment within 3 months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis
Recruitment took place at the clinic - June 16, 2010 through July 6, 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 RRMS Patients | Rebif 44 mcg sc tiw |
| FG001 | Arm 2 Healthy Control | Healthy Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 RRMS Patients | Rebif 44 mcg sc tiw |
| BG001 | Arm 2 Healthy Control | Healthy Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | The analysis were run on the Intent-to-Treat (ITT) set defined as all RRMS subjects with at least one injection of Rebif and all HC who signed the informed consent form. Missing data were not imputed. | Posted | Median | Full Range | mm^3 | Baseline to Month 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 RRMS Patients | Rebif 44 mcg sc tiw |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Sclerosis Relapse | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Dangond, MD FAAN | EMD Serono, Inc. | 781-681-2348 | fernando.dangond@emdserono.com |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Healthy Control |
|
|
|
| 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). | Posted | Median | Full Range | mm^3 | Baseline to Month 6 |
|
|
|
|
| Other Pre-specified | Clinical Relapses | Clinical Relapses | Posted | Mean | Standard Deviation | relapses per participant | Over 6 months |
|
|
|
| Other Pre-specified | Time to First Clinical Relapse | Time to First Clinical Relapse | Posted | Mean | Standard Deviation | months | Months |
|
|
|
| 2 |
| 23 |
| 22 |
| 23 |
| EG001 | Arm 2 Healthy Control | Healthy Control | 0 | 15 | 8 | 15 |
| Post procedural infection | Infections and infestations |
|
| Injection site reaction | General disorders |
|
| Multiple sclerosis relapse | Nervous system disorders |
|
| Fatigue | General disorders |
|
| Injection site pain | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Headache | Nervous system disorders |
|
| Migraine | Nervous system disorders |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Fall | Injury, poisoning and procedural complications |
|
| Gastroenteritis viral | Gastrointestinal disorders |
|
| Insomnia | Psychiatric disorders |
|
| Irritability | General disorders |
|
| Multiple sclerosis | Nervous system disorders |
|
| Sinusitis | Infections and infestations |
|
| Animal bite | Injury, poisoning and procedural complications |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Head injury | Injury, poisoning and procedural complications |
|
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders |
|
| Urinary tract infection | Infections and infestations |
|
| VIIth nerve paralysis | Nervous system disorders |
|
Neither Institution nor any Principal Investigators shall publish or present any results from such Study to any third parties until: (i) EMD Serono publishes the results from all sites participating in such Study; (ii) Institution receives notification from EMD Serono that publication of the multi-site results is no longer planned; or (iii) twenty-four (24) months following the completion of the multi-site study at all sites, whichever occurs first.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |