The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
This study is an open-label extension of study 20090072 (NCT01150890) in adults with Crohn's disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Administered intravenously once every 4 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug. The investigator assessed whether each AE was possibly related to the study drug. A serious adverse event is defined as an AE that met at least 1 of the following serious criteria: * fatal, * life threatening, * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other significant medical hazard.
Time frame: From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
Percentage of Participants Who Achieved a CDAI Response
CDAI response is defined as a reduction from baseline in CDAI score of ≥ 100 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Time frame: Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20
Percentage of Participants Who Achieved Clinical Remission
Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
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Research Site
Birmingham, Alabama, United States
Research Site
Jacksonville, Florida, United States
Research Site
Hammond, Louisiana, United States
Research Site
Chevy Chase, Maryland, United States
Research Site
Rochester, Minnesota, United States
Research Site
Mexico, Missouri, United States
Research Site
Great Neck, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
San Antonio, Texas, United States
...and 24 more locations
Time frame: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
CDAI Score Over Time
The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Time frame: Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Change From Baseline in CDAI Score Over Time
The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.
Time frame: Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20
Number of Participants Who Developed Anti-brodalumab Binding Antibodies
Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.
Time frame: Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).
Change From Baseline in C-reactive Protein (CRP) Levels Over Time
Time frame: Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20