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

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ClinicalTrials.gov Identifier: NCT01777412
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : May 29, 2015
Last Update Posted : August 21, 2015
Sponsor:
Collaborators:
Genentech, Inc.
Guthy Jackson Charitable Foundation
Information provided by (Responsible Party):
Michael Levy, Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Intervention Drug: Bevacizumab
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Bevacizumab
Hide Arm/Group Description 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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
45.5  (15.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
9
  90.0%
Male
1
  10.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  20.0%
White
7
  70.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
NMO/NMOSD 7
High risk for NMO 3
Anti-AQP4 antibody serostatus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Positive 6
Negative 4
1.Primary Outcome
Title Baseline Expanded Disability Status Score (EDSS)
Hide Description

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.

Time Frame Admission to hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3.5
(2.0 to 7.0)
2.Primary Outcome
Title Safety Assessment and Side Effects
Hide Description 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.
Time Frame 91 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Serious Adverse Event: Hospitalization 1
Side Effects 0
3.Primary Outcome
Title Follow-Up Expanded Disability Status Score (EDSS)
Hide Description

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.

Time Frame Follow-up visit 91 days after admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3.0
(1.75 to 6.5)
Time Frame 91 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab
Hide Arm/Group Description 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.
All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Infections and infestations   
Hospitalization for Urinary Tract Infection * [1]  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
47 days after infusion of bevacizumab, patient developed a urinary tract infection that required hospitalization for 1 night and initiation of antibiotics. The infection was treated completely without complications.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Nervous system disorders   
Headache * [1]  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Headache during the infusion of bevacizumab was noted. The headache resolved with fluids.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Levy
Organization: Johns Hopkins University
Phone: 443-287-4412
EMail: mlevy@jhmi.edu
Layout table for additonal information
Responsible Party: Michael Levy, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01777412     History of Changes
Other Study ID Numbers: Avastin_NMO_1
First Submitted: January 21, 2013
First Posted: January 28, 2013
Results First Submitted: May 13, 2015
Results First Posted: May 29, 2015
Last Update Posted: August 21, 2015