Trial · NCT02029495
Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
NCT02029495, Phase 3, Terminated, Bausch Health Americas, Inc.; results first posted 2017-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis. Trials, record NCT02029495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02029495
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
- NCT number
- NCT02029495
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 478 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Psoriatic Arthritis
- Interventions
- 210 mg brodalumab, 140 mg brodalumab, Placebo
- First posted
- 2014-01-08
- Last updated
- 2017-05-19
- Other registries' IDs
- eudract:2013-003554-25
- Results first posted
- 2017-05-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | American College of Rheumatology (ACR) 20 Response | 16 weeks | An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components). |
| Secondary | Psoriasis Area and Severity Index (PASI)75 | 16 Weeks | PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | American College of Rheumatology (ACR) 20 Response | 16 weeks | percentage of participants | NUMBER | |
| SECONDARY | Psoriasis Area and Severity Index (PASI)75 | 16 Weeks | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| American College of Rheumatology (ACR) 20 Response | 210 mg Brodalumab | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| American College of Rheumatology (ACR) 20 Response | 140 mg Brodalumab | 21.8 | 95% Confidence Interval 10.6 to 33.1 | percentage of participants | |
| American College of Rheumatology (ACR) 20 Response | Placebo | 36.5 | 95% Confidence Interval 22.8 to 45.3 | percentage of participants | |
| Psoriasis Area and Severity Index (PASI)75 | 210 mg Brodalumab | 70.3 | 95% Confidence Interval 57.6 to 82.9 | percentage of participants | |
| Psoriasis Area and Severity Index (PASI)75 | 140 mg Brodalumab | 55.6 | 95% Confidence Interval 27.9 to 56.6 | percentage of participants | |
| Psoriasis Area and Severity Index (PASI)75 | Placebo | 0 | 95% Confidence Interval 0 to 0 | 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 | 159 | |
| Overall Study | STARTED | 140 mg Brodalumab | 158 | |
| Overall Study | STARTED | Placebo | 161 | |
| Overall Study | COMPLETED | 210 mg Brodalumab | 158 | |
| Overall Study | COMPLETED | 140 mg Brodalumab | 158 | |
| Overall Study | COMPLETED | Placebo | 159 | |
| Overall Study | NOT COMPLETED | 210 mg Brodalumab | 1 | |
| Overall Study | NOT COMPLETED | 140 mg Brodalumab | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events147
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 | 24 | 158 | |
| other | Nasopharyngitis | Infections and infestations | 140 mg Brodalumab | 28 | 158 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 7 | 159 | |
| other | Upper Respiratory tract Infection | Infections and infestations | 210 mg Brodalumab | 9 | 158 | |
| other | Upper Respiratory tract Infection | Infections and infestations | 140 mg Brodalumab | 9 | 158 | |
| other | Upper Respiratory tract Infection | Infections and infestations | Placebo | 8 | 159 | |
| other | Diarrheoa | Gastrointestinal disorders | 210 mg Brodalumab | 2 | 158 | |
| other | Diarrheoa | Gastrointestinal disorders | 140 mg Brodalumab | 5 | 158 | |
| other | Diarrheoa | Gastrointestinal disorders | Placebo | 3 | 159 | |
| other | Headache | Nervous system disorders | 210 mg Brodalumab | 5 | 158 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 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 | 84 | 158 |
| Total, other adverse events | 140 mg Brodalumab | 79 | 158 |
| Total, other adverse events | Placebo | 71 | 159 |
| Total, serious adverse events | 210 mg Brodalumab | 10 | 158 |
| Total, serious adverse events | 140 mg Brodalumab | 5 | 158 |
| Total, serious adverse events | Placebo | 4 | 159 |
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/NCT02029495
GET https://conductscience.org/api/trials/v1/NCT02029495/events?page=2