Trial Outcomes & Findings for Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations (NCT NCT01777412)

NCT ID: NCT01777412

Last Updated: 2015-08-21

Results Overview

EDSS The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: Admission to hospital
• Results posted on: 2015-08-21

Participant Flow

Participant milestones

Measure	Bevacizumab Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations

Baseline characteristics by cohort

Measure	Bevacizumab n=10 Participants Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
Age, Continuous	45.5 years STANDARD_DEVIATION 15.5 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Diagnosis NMO/NMOSD	7 participants n=93 Participants
Diagnosis High risk for NMO	3 participants n=93 Participants
Anti-AQP4 antibody serostatus Positive	6 participants n=93 Participants
Anti-AQP4 antibody serostatus Negative	4 participants n=93 Participants

PRIMARY outcome

Timeframe: Admission to hospital

EDSS

The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.

Outcome measures

Measure	Bevacizumab n=10 Participants Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
Baseline Expanded Disability Status Score (EDSS)	3.5 units on a scale Interval 2.0 to 7.0

PRIMARY outcome

Timeframe: 91 days

Frequency and severity of adverse events and side effects. Serious adverse events are considered those which are life threatening, lead to hospitalization and related to the drug. Side effects are considered minor effects of the experimental drug that do not significantly impact the care of the patient with the experimental drug.

Outcome measures

Measure	Bevacizumab n=10 Participants Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
Safety Assessment and Side Effects Serious Adverse Event: Hospitalization	1 participants
Safety Assessment and Side Effects Side Effects	0 participants

PRIMARY outcome

Timeframe: Follow-up visit 91 days after admission

EDSS

The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability.

Outcome measures

Measure	Bevacizumab n=10 Participants Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
Follow-Up Expanded Disability Status Score (EDSS)	3.0 units on a scale Interval 1.75 to 6.5

Adverse Events

Bevacizumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab n=10 participants at risk Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
Infections and infestations Hospitalization for Urinary Tract Infection	10.0% 1/10 • Number of events 1 • 91 days

Other adverse events

Measure	Bevacizumab n=10 participants at risk Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • 91 days

Additional Information

Michael Levy

Johns Hopkins University

Phone: 443-287-4412

Email: mlevy@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place