A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
Presence of active plaque psoriasis with a BSA ≥3%
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)

Exclusion Criteria

Current or prior use of biologic agents for treatment of Ps or PsA
Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than psoriatic arthritis
Serious infection within the last 3 months
Active Crohn's disease or active ulcerative colitis
Active vasculitis or uveitis
Diagnosis of or history of malignant disease <5 years prior to randomization
Women who are breastfeeding

Arm && Interventions

Group	Intervention	Description
Adalimumab	Adalimumab	80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Ixekizumab	Ixekizumab	160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)	Week 24	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving PASI100	Week 24	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.
Percentage of Participants Achieving ACR50	Week 24	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).

Locations (131): Atencion Integral en Reumatología
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Clinica Adventista de Belgrano
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Ciudad de Buenos Aires, Buenos Aires, Argentina
CER Instituto Medico
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Quilmes, Buenos Aires, Argentina
Instituto de Asist Reumatologica Integral
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San Fernando, Buenos Aires, Argentina
Centro Medico Privado de Reumatologia
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San Miguel de Tucuman, Tucuman, Argentina
Organizacion Medica de Investigacion - OMI
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Ciudad Autonoma de Buenos Aire, Argentina
Instituto Centenario
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Ciudad Autonoma de Buenos Aire, Argentina
Hospital Ramos Mejia
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Ciudad Autonoma de Buenos Aire, Argentina
Centro de Medicina Familiar Mindout Research
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Ciudad Autonoma de Buenos Aire, Argentina
CENUDIAB
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Ciudad Autonoma de Buenos Aire, Argentina
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Atencion Integral en Reumatología
🇦🇷Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina