Trial Outcomes & Findings for Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial (NCT NCT01085318)
NCT ID: NCT01085318
Last Updated: 2018-02-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
Baseline to Month 6
Results posted on
2018-02-23
Participant Flow
Recruitment took place at the clinic - June 16, 2010 through July 6, 2011
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
Participant milestones
| Measure |
Arm 1 RRMS Patients
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
Healthy Control
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
15
|
|
Overall Study
COMPLETED
|
21
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
Baseline characteristics by cohort
| Measure |
Arm 1 RRMS Patients
n=23 Participants
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
n=15 Participants
Healthy Control
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 10.31 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
15 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: 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.
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).
Outcome measures
| Measure |
Arm 1 RRMS Patients
n=21 Participants
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
n=13 Participants
Healthy Control
|
|---|---|---|
|
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
|
1206.1 mm^3
Full Range 4081.621 • Interval 0.0 to 15278.1
|
342 mm^3
Full Range 291.890 • Interval 0.0 to 951.0
|
SECONDARY outcome
Timeframe: Baseline to Month 6To 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).
Outcome measures
| Measure |
Arm 1 RRMS Patients
n=21 Participants
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
n=13 Participants
Healthy Control
|
|---|---|---|
|
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
|
941.99 mm^3
Full Range 1262.565 • Interval 0.0 to 6140.6
|
297 mm^3
Full Range 311.269 • Interval 0.0 to 852.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Over 6 monthsClinical Relapses
Outcome measures
| Measure |
Arm 1 RRMS Patients
n=23 Participants
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
Healthy Control
|
|---|---|---|
|
Clinical Relapses
|
0.3 relapses per participant
Standard Deviation 0.88
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MonthsTime to First Clinical Relapse
Outcome measures
| Measure |
Arm 1 RRMS Patients
n=23 Participants
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
Healthy Control
|
|---|---|---|
|
Time to First Clinical Relapse
|
2.5 months
Standard Deviation 1.88
|
—
|
Adverse Events
Arm 1 RRMS Patients
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Arm 2 Healthy Control
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 RRMS Patients
n=23 participants at risk
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
n=15 participants at risk
Healthy Control
|
|---|---|---|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
4.3%
1/23 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Post procedural infection
|
4.3%
1/23 • Number of events 1
|
0.00%
0/15
|
Other adverse events
| Measure |
Arm 1 RRMS Patients
n=23 participants at risk
Rebif 44 mcg sc tiw
|
Arm 2 Healthy Control
n=15 participants at risk
Healthy Control
|
|---|---|---|
|
General disorders
Influenza like illness
|
39.1%
9/23
|
0.00%
0/15
|
|
General disorders
Injection site reaction
|
34.8%
8/23
|
0.00%
0/15
|
|
Nervous system disorders
Multiple sclerosis relapse
|
21.7%
5/23
|
0.00%
0/15
|
|
General disorders
Fatigue
|
17.4%
4/23
|
0.00%
0/15
|
|
General disorders
Injection site pain
|
17.4%
4/23
|
0.00%
0/15
|
|
Infections and infestations
Nasopharyngitis
|
17.4%
4/23
|
13.3%
2/15
|
|
Nervous system disorders
Headache
|
13.0%
3/23
|
0.00%
0/15
|
|
Nervous system disorders
Migraine
|
13.0%
3/23
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.0%
3/23
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
2/23
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
8.7%
2/23
|
0.00%
0/15
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23
|
0.00%
0/15
|
|
General disorders
Irritability
|
8.7%
2/23
|
0.00%
0/15
|
|
Nervous system disorders
Multiple sclerosis
|
8.7%
2/23
|
0.00%
0/15
|
|
Infections and infestations
Sinusitis
|
8.7%
2/23
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/23
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/23
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/23
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/23
|
6.7%
1/15
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23
|
6.7%
1/15
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/23
|
6.7%
1/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER