Trial Outcomes & Findings for Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis (NCT NCT01395316)

Results Overview

Changes in normal appearing white matter from baseline through month 24. The MRI is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

Baseline to Month 24

Results posted on

2018-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	Alemtuzumab Single arm, single cohort study, all subjects will be dosed with alemtuzumab. Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Alemtuzumab Single arm, single cohort study, all subjects will be dosed with alemtuzumab. Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
Overall Study Lost to Follow-up	2
Overall Study poor MRI quality	1

Baseline Characteristics

Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alemtuzumab n=8 Participants Single arm, single cohort study, all subjects will be dosed with alemtuzumab. Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
Age, Continuous	32.6 years STANDARD_DEVIATION 7.7 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to Month 24

Changes in normal appearing white matter from baseline through month 24. The MRI is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.

Outcome measures

Outcome measures
Measure	Alemtuzumab n=5 Participants Single arm, single cohort study, all subjects will be dosed with alemtuzumab. Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
Diffusion and Myelin Fraction Water Changes on Magnetic Resonance Imaging (MRI)	-2.06 percent Change Standard Deviation 0.01

Adverse Events

Alemtuzumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Alemtuzumab n=8 participants at risk Single arm, single cohort study, all subjects will be dosed with alemtuzumab. Alemtuzumab: 10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
Endocrine disorders Hypothyroidism	12.5% 1/8 • Number of events 1

Additional Information

Dr. Adil Javed

University of Chicago

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place