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

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ClinicalTrials.gov Identifier: NCT01085318
Recruitment Status : Completed
First Posted : March 11, 2010
Results First Posted : May 3, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Multiple Sclerosis
Intervention Drug: Rebif
Enrollment 38
Recruitment Details Recruitment took place at the clinic - June 16, 2010 through July 6, 2011
Pre-assignment Details 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
Arm/Group Title Arm 1 RRMS Patients Arm 2 Healthy Control
Hide Arm/Group Description Rebif 44 mcg sc tiw Healthy Control
Period Title: Overall Study
Started 23 15
Completed 21 15
Not Completed 2 0
Arm/Group Title Arm 1 RRMS Patients Arm 2 Healthy Control Total
Hide Arm/Group Description Rebif 44 mcg sc tiw Healthy Control Total of all reporting groups
Overall Number of Baseline Participants 23 15 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 15 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
15
 100.0%
38
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 15 participants 38 participants
39.9  (10.17) 36.7  (10.31) 38.6  (10.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 15 participants 38 participants
Female
14
  60.9%
8
  53.3%
22
  57.9%
Male
9
  39.1%
7
  46.7%
16
  42.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 15 participants 38 participants
23 15 38
1.Primary Outcome
Title 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
Hide Description 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).
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 RRMS Patients Arm 2 Healthy Control
Hide Arm/Group Description:
Rebif 44 mcg sc tiw
Healthy Control
Overall Number of Participants Analyzed 21 13
Median (Full Range)
Unit of Measure: mm^3
1206.1
(0 to 15278.1)
342
(0 to 951)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 RRMS Patients, Arm 2 Healthy Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 864.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 RRMS Patients Arm 2 Healthy Control
Hide Arm/Group Description:
Rebif 44 mcg sc tiw
Healthy Control
Overall Number of Participants Analyzed 21 13
Median (Full Range)
Unit of Measure: mm^3
941.99
(0 to 6140.6)
297
(0 to 852)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 RRMS Patients, Arm 2 Healthy Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 644.99
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Clinical Relapses
Hide Description Clinical Relapses
Time Frame Over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 RRMS Patients
Hide Arm/Group Description:
Rebif 44 mcg sc tiw
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: relapses per participant
0.3  (0.88)
4.Other Pre-specified Outcome
Title Time to First Clinical Relapse
Hide Description Time to First Clinical Relapse
Time Frame Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 RRMS Patients
Hide Arm/Group Description:
Rebif 44 mcg sc tiw
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: months
2.5  (1.88)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 RRMS Patients Arm 2 Healthy Control
Hide Arm/Group Description Rebif 44 mcg sc tiw Healthy Control
All-Cause Mortality
Arm 1 RRMS Patients Arm 2 Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 RRMS Patients Arm 2 Healthy Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/23 (8.70%)      0/15 (0.00%)    
Infections and infestations     
Post procedural infection  1/23 (4.35%)  1 0/15 (0.00%)  0
Nervous system disorders     
Multiple Sclerosis Relapse  1/23 (4.35%)  1 0/15 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 RRMS Patients Arm 2 Healthy Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/23 (95.65%)      8/15 (53.33%)    
Gastrointestinal disorders     
Nausea  3/23 (13.04%)  0/15 (0.00%) 
Gastroenteritis viral  2/23 (8.70%)  0/15 (0.00%) 
General disorders     
Influenza like illness  9/23 (39.13%)  0/15 (0.00%) 
Injection site reaction  8/23 (34.78%)  0/15 (0.00%) 
Fatigue  4/23 (17.39%)  0/15 (0.00%) 
Injection site pain  4/23 (17.39%)  0/15 (0.00%) 
Irritability  2/23 (8.70%)  0/15 (0.00%) 
Infections and infestations     
Nasopharyngitis  4/23 (17.39%)  2/15 (13.33%) 
Sinusitis  2/23 (8.70%)  0/15 (0.00%) 
Urinary tract infection  0/23 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Fall  2/23 (8.70%)  0/15 (0.00%) 
Animal bite  0/23 (0.00%)  1/15 (6.67%) 
Head injury  0/23 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  3/23 (13.04%)  0/15 (0.00%) 
Arthralgia  0/23 (0.00%)  1/15 (6.67%) 
Nervous system disorders     
Multiple sclerosis relapse  5/23 (21.74%)  0/15 (0.00%) 
Headache  3/23 (13.04%)  0/15 (0.00%) 
Migraine  3/23 (13.04%)  0/15 (0.00%) 
Multiple sclerosis  2/23 (8.70%)  0/15 (0.00%) 
VIIth nerve paralysis  0/23 (0.00%)  1/15 (6.67%) 
Psychiatric disorders     
Insomnia  2/23 (8.70%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  0/23 (0.00%)  1/15 (6.67%) 
Lower respiratory tract infection  0/23 (0.00%)  1/15 (6.67%) 
Upper respiratory tract infection  0/23 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders     
Rash  0/23 (0.00%)  1/15 (6.67%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fernando Dangond, MD FAAN
Organization: EMD Serono, Inc.
Phone: 781-681-2348
EMail: fernando.dangond@emdserono.com
Layout table for additonal information
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01085318     History of Changes
Other Study ID Numbers: 29665
First Submitted: March 10, 2010
First Posted: March 11, 2010
Results First Submitted: February 11, 2013
Results First Posted: May 3, 2013
Last Update Posted: February 23, 2018