Trial · NCT01199302
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
NCT01199302, Phase 2, Terminated, Amgen; results first posted 2021-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety Study of Brodalumab in Adults With Crohn's Disease. Trials, record NCT01199302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01199302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
- NCT number
- NCT01199302
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Crohn's Disease
- Interventions
- Brodalumab
- First posted
- 2010-09-10
- Last updated
- 2021-12-28
- Other registries' IDs
- eudract:2010-020881-53
- Results first posted
- 2021-12-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223) | 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. |
| Primary | Percentage of Participants Who Achieved a CDAI Response | Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20 | 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. |
| Primary | Percentage of Participants Who Achieved Clinical Remission | Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | 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. |
| Secondary | CDAI Score Over Time | Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | 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. |
| Secondary | Change From Baseline in CDAI Score Over Time | Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | 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. |
| Secondary | Number of Participants Who Developed Anti-brodalumab Binding Antibodies | Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks). | Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay. |
| Secondary | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223) | All enrolled participants who received at least one dose of brodalumab in the extension study | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants Who Achieved a CDAI Response | Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20 | Participants in the full analysis set with available data at each time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Clinical Remission | Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | Participants in the full analysis set with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | CDAI Score Over Time | Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | Participants in the full analysis set with available data at each time point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in CDAI Score Over Time | Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | Participants in the full analysis set with available data at each time point. | score on a scale | MEAN |
| SECONDARY | Number of Participants Who Developed Anti-brodalumab Binding Antibodies | Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks). | Enrolled participants who received at least one dose of brodalumab in the extension study and with available antibody results | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in C-reactive Protein (CRP) Levels Over Time | Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20 | Participants in the full analysis set with available data at each time point. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group200
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo / Brodalumab 350 mg | All treatment-emergent adverse events (TEAEs) | 14 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Brodalumab 210 mg / 350 mg | All treatment-emergent adverse events (TEAEs) | 12 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Brodalumab 350 mg / 350 mg | All treatment-emergent adverse events (TEAEs) | 18 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Brodaluamb 700 mg / 350 mg | All treatment-emergent adverse events (TEAEs) | 8 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo / Brodalumab 350 mg | Serious adverse events | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Brodalumab 210 mg / 350 mg | Serious adverse events | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Brodalumab 350 mg / 350 mg | Serious adverse events | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Brodaluamb 700 mg / 350 mg | Serious adverse events | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo / Brodalumab 350 mg | Fatal adverse events | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Brodalumab 210 mg / 350 mg | Fatal adverse events | 0 | Participants |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo / Brodalumab 350 mg | 20 | |
| Overall Study | STARTED | Brodalumab 210 mg / 350 mg | 16 | |
| Overall Study | STARTED | Brodalumab 350 mg / 350 mg | 20 | |
| Overall Study | STARTED | Brodaluamb 700 mg / 350 mg | 11 | |
| Overall Study | COMPLETED | Placebo / Brodalumab 350 mg | 0 | |
| Overall Study | COMPLETED | Brodalumab 210 mg / 350 mg | 0 | |
| Overall Study | COMPLETED | Brodalumab 350 mg / 350 mg | 0 | |
| Overall Study | COMPLETED | Brodaluamb 700 mg / 350 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo / Brodalumab 350 mg | 20 | |
| Overall Study | NOT COMPLETED | Brodalumab 210 mg / 350 mg | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 7 | 67 | |
| other | Abdominal tenderness | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 3 | 67 | |
| other | Constipation | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 3 | 67 | |
| other | Crohn's disease | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 9 | 67 | |
| other | Diarrhoea | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 4 | 67 | |
| other | Dyspepsia | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 3 | 67 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 4 | 67 | |
| other | Nausea | Gastrointestinal disorders | Brodalumab 350 mg Q4W | 3 | 67 | |
| other | Chills | General disorders | Brodalumab 350 mg Q4W | 3 | 67 | |
| other | Fatigue | General disorders | Brodalumab 350 mg Q4W | 5 | 67 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brodalumab 350 mg Q4W | ||
| Total, other adverse events | Brodalumab 350 mg Q4W | 36 | 67 |
| Total, serious adverse events | Brodalumab 350 mg Q4W | 15 | 67 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01199302
GET https://conductscience.org/api/trials/v1/NCT01199302/results?page=2