Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
Source: ClinicalTrials.gov NCT02024646 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 |
41.8; 48.9; 24.7 | — |
Eligibility Criteria
Inclusion Criteria
Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least
1 psoriatic skin lesion. Exclusion Criteria:
- -Subject has known history of active tuberculosis.
- Subject has a planned surgical intervention between baseline and the week 52 evaluation.
- Subject has an active infection or history of infections.
- Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled.
- Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
- Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
Data sourced from ClinicalTrials.gov (NCT02024646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.