The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
566
Administered SC
Administered SC
Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\& swollen joint count (SJC)\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \& BSA=0 at week 24.
Time frame: Week 24
Percentage of Participants Achieving ACR50
ACR50 response is defined as a ≥50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).
Time frame: Week 24
Percentage of Participants Achieving PASI100
PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if \& only if they had achieved PASI=0 \& BSA=0 at week 24.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Atencion Integral en Reumatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Clinica Adventista de Belgrano
Ciudad de Buenos Aires, Buenos Aires, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, Argentina
Instituto de Asist Reumatologica Integral
San Fernando, Buenos Aires, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Organizacion Medica de Investigacion - OMI
Ciudad Autonoma de Buenos Aire, Argentina
Instituto Centenario
Ciudad Autonoma de Buenos Aire, Argentina
Hospital Ramos Mejia
Ciudad Autonoma de Buenos Aire, Argentina
Centro de Medicina Familiar Mindout Research
Ciudad Autonoma de Buenos Aire, Argentina
CENUDIAB
Ciudad Autonoma de Buenos Aire, Argentina
...and 121 more locations
Time frame: Week 24