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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryAmerican College of Rheumatology (ACR) 20 Response16 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).
SecondaryPsoriasis Area and Severity Index (PASI)7516 WeeksPASI75 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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAmerican College of Rheumatology (ACR) 20 Response16 weekspercentage of participantsNUMBER
SECONDARYPsoriasis Area and Severity Index (PASI)7516 Weekspercentage of participantsNUMBER

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
American College of Rheumatology (ACR) 20 Response210 mg Brodalumab095% Confidence Interval 0 to 0percentage of participants
American College of Rheumatology (ACR) 20 Response140 mg Brodalumab21.895% Confidence Interval 10.6 to 33.1percentage of participants
American College of Rheumatology (ACR) 20 ResponsePlacebo36.595% Confidence Interval 22.8 to 45.3percentage of participants
Psoriasis Area and Severity Index (PASI)75210 mg Brodalumab70.395% Confidence Interval 57.6 to 82.9percentage of participants
Psoriasis Area and Severity Index (PASI)75140 mg Brodalumab55.695% Confidence Interval 27.9 to 56.6percentage of participants
Psoriasis Area and Severity Index (PASI)75Placebo095% Confidence Interval 0 to 0percentage of participants

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED210 mg Brodalumab159
Overall StudySTARTED140 mg Brodalumab158
Overall StudySTARTEDPlacebo161
Overall StudyCOMPLETED210 mg Brodalumab158
Overall StudyCOMPLETED140 mg Brodalumab158
Overall StudyCOMPLETEDPlacebo159
Overall StudyNOT COMPLETED210 mg Brodalumab1
Overall StudyNOT COMPLETED140 mg Brodalumab0
Overall StudyNOT COMPLETEDPlacebo2

Adverse events147

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherNasopharyngitisInfections and infestations210 mg Brodalumab24158
otherNasopharyngitisInfections and infestations140 mg Brodalumab28158
otherNasopharyngitisInfections and infestationsPlacebo7159
otherUpper Respiratory tract InfectionInfections and infestations210 mg Brodalumab9158
otherUpper Respiratory tract InfectionInfections and infestations140 mg Brodalumab9158
otherUpper Respiratory tract InfectionInfections and infestationsPlacebo8159
otherDiarrheoaGastrointestinal disorders210 mg Brodalumab2158
otherDiarrheoaGastrointestinal disorders140 mg Brodalumab5158
otherDiarrheoaGastrointestinal disordersPlacebo3159
otherHeadacheNervous system disorders210 mg Brodalumab5158

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortality210 mg Brodalumab
Total, all-cause mortality140 mg Brodalumab
Total, all-cause mortalityPlacebo
Total, other adverse events210 mg Brodalumab84158
Total, other adverse events140 mg Brodalumab79158
Total, other adverse eventsPlacebo71159
Total, serious adverse events210 mg Brodalumab10158
Total, serious adverse events140 mg Brodalumab5158
Total, serious adverse eventsPlacebo4159

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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