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临床试验/NCT03158285
NCT03158285已完成3 期

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis

Janssen Research & Development, LLC267 个研究点 分布在 8 个国家目标入组 741 人开始时间: 2017年7月12日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
741
试验地点
267
主要终点
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

详细描述

This is a study of guselkumab in participants with active PsA who are biologically naive and have had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA. The study will consist of a screening phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24 to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
  • •Have active PsA as defined by: at least 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (>=) 0.6 milligram per deciLitre (mg/dL) at screening from the central laboratory
  • •Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented)
  • •Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
  • •Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

排除标准

  • •Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
  • •Has previously received any biologic treatment
  • •Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
  • •Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
  • •Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate [MTX], sulfasalazine [SSZ], Hydroxychloroquine [HCQ], leflunomide [LEF]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent
  • •Has received apremilast within 4 weeks prior to the first administration of study agent

研究组 & 干预措施

Group 1: Guselkumab

Experimental

Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 100.

干预措施: Guselkumab (Drug)

Group 2: Guselkumab and Placebo

Experimental

Participants will receive SC guselkumab 100 mg at Weeks 0 and 4 then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.

干预措施: Placebo (Drug)

Group 3: Placebo Followed by Guselkumab

Experimental

Participants will receive SC placebo q4w from Week 0 to Week 20 and will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.

干预措施: Placebo (Drug)

Group 2: Guselkumab and Placebo

Experimental

Participants will receive SC guselkumab 100 mg at Weeks 0 and 4 then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.

干预措施: Guselkumab (Drug)

Group 3: Placebo Followed by Guselkumab

Experimental

Participants will receive SC placebo q4w from Week 0 to Week 20 and will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.

干预措施: Guselkumab (Drug)

结局指标

主要结局

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

时间窗: Week 24

ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.

次要结局

  • Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16(Week 16)
  • Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24(Baseline, Weeks 16 and 24)
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24(Baseline and Week 24)
  • Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline(Week 24)
  • Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline(Week 24)
  • Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline(Baseline, Weeks 2, 4, 8, 16 and 24)
  • Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24(Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage of Participants Who Achieved an ACR 50 Response at Week 24(Week 24)
  • Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline(Week 24)
  • Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24(Baseline and Week 24)
  • Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24(Baseline and Week 24)
  • Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline(Baseline and Week 24)
  • Percentage of Participants Who Achieved ACR 70 Response Through Week 24(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24(Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline(Weeks 2, 4, 8, 16 and 24)
  • Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline(Baseline and Week 24)
  • Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24(Baseline and Week 24)
  • Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24(Baseline, Weeks 8, 16 and 24)
  • Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24(Baseline, Weeks 16 and 24)
  • Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24(Baseline, Weeks 16 and 24)
  • Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24(Weeks 16 and 24)
  • Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24(Baseline and Week 24)
  • Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16(Week 16)
  • Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24(Week 24)
  • Percentage of Participants Who Achieved ACR 20 Response Through Week 24(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Percentage of Participants Who Achieved ACR 50 Response Through Week 24(Weeks 2, 4, 8, 12, 16, 20 and 24)
  • Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24(Baseline, Weeks 16 and 24)
  • Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline(Weeks 2, 4, 8, 16 and 24)
  • Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline(Baseline, Weeks 2, 4, 8, 16 and 24)
  • Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 16 and 24)
  • Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24(Week 24)
  • Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24(Baseline, Weeks 8, 16 and 24)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24(Week 8, 16 and 24)
  • Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24(Baseline, Weeks 16 and 24)
  • Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24(Baseline, Weeks 16 and 24)
  • Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline(Weeks 8, 16 and 24)
  • Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline(Weeks 16 and 24)
  • Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 16 and 24)
  • Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Baseline, Weeks 16 and 24)
  • Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 8, 16, 24)
  • Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 16 and 24)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 8, 16, 24)
  • Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Baseline, Weeks 8, 16 and 24)
  • Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24(Baseline and Week 24)
  • Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24(Baseline, Weeks 8, 16 and 24)
  • Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52(Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 16 and 24)
  • Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 16 and 24)
  • Change From Baseline in Modified vdH-S Erosion Score at Week 24(Baseline and Week 24)
  • Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24(Baseline and Week 24)
  • Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24(Week 24)
  • Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24(Week 24)
  • Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24(Week 24)
  • Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS(Baseline, Weeks 16 and 24)
  • ACR Components at Weeks 24, 28, 36, 44 and 52(Weeks 24, 28, 36, 44 and 52)
  • Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52(Baseline, Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24(Week 24)
  • Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24(Week 24)
  • Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24(Baseline and Week 24)
  • Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index(Baseline, Weeks 16 and 24)
  • Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24(Baseline and Weeks 8, 16 and 24)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24(Week 8, 16 and 24)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24(Baseline, Weeks 8, 16 and 24)
  • Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24(Weeks 8, 16 and 24)
  • Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24(Week 52)
  • Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24(Week 52)
  • Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52(Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52(Weeks 24, 28, 36, 44 and 52)
  • Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52(Baseline, Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24(Week 52)
  • Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52(Baseline, Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline(Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24(Week 52)
  • Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52(Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52(Weeks 24, 28, 36, 44 and 52)
  • Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52(Baseline, Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52(Weeks 24, 28, 36, 44 and 52)
  • Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline(Weeks 24 and 52)
  • Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline(Baseline, Weeks 24 and 52)
  • Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline(Weeks 24 and 52)
  • Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline(Baseline, Weeks 24 and 52)
  • Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52(Weeks 24 and 52)
  • Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52(Weeks 24 and 52)
  • Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Change From Baseline in Modified vdH-S Score at Week 52(Baseline and Week 52)
  • Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52(Weeks 24 and 52)
  • Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52(Weeks 24 and 52)
  • Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52(Baseline, Weeks 24, 28, 36, 44 and 52)
  • Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52(Weeks 24 and 52)
  • Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline(Baseline, Weeks 24 and 52)
  • Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline(Weeks 24 and 52)
  • Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Baseline, Weeks 24 and 52)
  • Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Baseline, Weeks 24 and 52)
  • Change in Modified vdH-S Erosion Score From Week 24 to Week 52(From Week 24 to Week 52)
  • Change From Baseline in Modified vdH-S JSN Score at Week 52(Baseline and Week 52)
  • Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52(Baseline and Week 52)
  • Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 24 and 52)
  • Change From Baseline in SF-36 PCS Score at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Change From Baseline in SF-36 MCS Score at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Change in Total Modified vdH-S Score From Week 24 to Week 52(From Week 24 to Week 52)
  • Change From Baseline in Modified vdH-S Erosion Score at Week 52(Baseline and Week 52)
  • Change in Modified vdH-S JSN Score From Week 24 to Week 52(From Week 24 to Week 52)
  • Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52(Week 100)
  • Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52(Week 52)
  • Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52(Week 52)
  • Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52(Week 52)
  • Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52(Week 52)
  • Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52(Week 52)
  • Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52(Week 52)
  • Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52(Baseline and Week 52)
  • Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52(Weeks 24 and 52)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52(Weeks 24 and 52)
  • Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52(Weeks 24 and 52)
  • Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS(Baseline, Weeks 24 and 52)
  • Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index(Baseline, Weeks 24 and 52)
  • Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52(Baseline, Weeks 24 and 52)
  • ACR Components at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100(Baseline, Weeks 52, 68, 76, 84 and 100)
  • Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100(Baseline, Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52(Week 100)
  • Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100(Baseline, Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Percentage of Participants With VLDA at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52(Week 100)
  • Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52(Week 100)
  • Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline(Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline(Weeks 52, 76 and 100)
  • Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100(Baseline, Weeks 52, 68, 76, 84 and 100)
  • Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100(Baseline, Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100(Weeks 52, 68, 76, 84 and 100)
  • Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline(Weeks 52, 76, and 100)
  • Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Change From Baseline in PASDAS Score at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score(Baseline to Week 100)
  • Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100(Baseline to Week 100)
  • Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline(Weeks 52, 76 and 100)
  • Change in Modified vdH-S Score From Baseline to Week 100(Baseline to Week 100)
  • Change in Modified vdH-s JSN Score From Week 52 to Week 100(From Week 52 to Week 100)
  • Change in Total Modified vdH-S Score From Week 52 to Week 100(From Week 52 to Week 100)
  • Change in Modified vdH-s Erosion Score From Baseline to Week 100(Baseline to Week 100)
  • Change in Modified vdH-s Erosion Score From Week 52 to Week 100(From Week 52 to Week 100)
  • Change in Modified vdH-s JSN Score From Baseline to Week 100(Baseline to Week 100)
  • Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores)(Baseline to Week 100)
  • Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score(Baseline to Week 100)
  • Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score(Baseline to Week 100)
  • Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100(Baseline to Week 100)
  • Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100(Baseline to Week 100)
  • Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100(Baseline, Weeks 24, 52, and 100)
  • Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100(Weeks 52, 76 and 100)
  • Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)
  • Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100(Baseline, Weeks 52, 76 and 100)

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