Trial · NCT02024646
Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
NCT02024646, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2020-08-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis. Trials, record NCT02024646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02024646
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
- NCT number
- NCT02024646
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 484 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Psoriatic Arthritis
- Interventions
- 210 mg brodalumab, 140 mg brodalumab, Placebo
- First posted
- 2013-12-31
- Last updated
- 2020-08-20
- Other registries' IDs
- eudract:2013-003553-16
- Results first posted
- 2020-08-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | Baseline and 16 Weeks | ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | Baseline and 16 Weeks | The Primary Analysis Set consists of all randomized subjects who had the opportunity to complete the week 16 visit prior to termination of the study.~The numbers in the outcome measure data table reflect the percentage of subjects achieving ACR20. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | 210 mg Brodalumab | 41.8 | Percentage of Participants | ||
| ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | 140 mg Brodalumab | 48.9 | Percentage of Participants | ||
| ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | Placebo | 24.7 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 210 mg Brodalumab | 163 | |
| Overall Study | STARTED | 140 mg Brodalumab | 160 | |
| Overall Study | STARTED | Placebo | 161 | |
| Overall Study | COMPLETED | 210 mg Brodalumab | 131 | |
| Overall Study | COMPLETED | 140 mg Brodalumab | 135 | |
| Overall Study | COMPLETED | Placebo | 133 | |
| Overall Study | NOT COMPLETED | 210 mg Brodalumab | 32 | |
| Overall Study | NOT COMPLETED | 140 mg Brodalumab | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 28 |
Source ClinicalTrials.gov
Adverse events126
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 | Nasopharyngitis | Infections and infestations | 210 mg Brodalumab | 28 | 163 | |
| other | Nasopharyngitis | Infections and infestations | 140 mg Brodalumab | 17 | 160 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 7 | 161 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | 210 mg Brodalumab | 16 | 163 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | 140 mg Brodalumab | 16 | 160 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 2 | 161 | |
| other | Sinusitus | Infections and infestations | 210 mg Brodalumab | 10 | 163 | |
| other | Sinusitus | Infections and infestations | 140 mg Brodalumab | 2 | 160 | |
| other | Sinusitus | Infections and infestations | Placebo | 2 | 161 | |
| other | Oral Herpes | Infections and infestations | 210 mg Brodalumab | 6 | 163 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 210 mg Brodalumab | ||
| Total, all-cause mortality | 140 mg Brodalumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | 210 mg Brodalumab | 91 | 163 |
| Total, other adverse events | 140 mg Brodalumab | 85 | 160 |
| Total, other adverse events | Placebo | 83 | 161 |
| Total, serious adverse events | 210 mg Brodalumab | 5 | 163 |
| Total, serious adverse events | 140 mg Brodalumab | 3 | 160 |
| Total, serious adverse events | Placebo | 5 | 161 |
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/NCT02024646
GET https://conductscience.org/api/trials/v1/NCT02024646/events?page=2