Clinical trial NCT03158285: A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-05-18
Enrollment: 741
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieved an ACR 50 Response at Week 24
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
timeFrame: Week 16
measure: Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
timeFrame: Week 24
measure: Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline
timeFrame: Week 24
measure: Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline and Week 24
measure: Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline
timeFrame: Baseline and Week 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Achieved ACR 20 Response Through Week 24
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved ACR 50 Response Through Week 24
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved ACR 70 Response Through Week 24
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: 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
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline
timeFrame: Weeks 2, 4, 8, 16 and 24
measure: Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline
timeFrame: Weeks 2, 4, 8, 16 and 24
measure: Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline, Weeks 2, 4, 8, 16 and 24
measure: Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline
timeFrame: Baseline, Weeks 2, 4, 8, 16 and 24
measure: Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24
timeFrame: Weeks 16 and 24
measure: 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
timeFrame: Weeks 8, 16 and 24
measure: 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
timeFrame: Weeks 16 and 24
measure: 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
timeFrame: Weeks 16 and 24
measure: 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
timeFrame: Weeks 16 and 24
measure: 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
timeFrame: Weeks 16 and 24
measure: 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
timeFrame: Baseline, Weeks 16 and 24
measure: 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
timeFrame: Weeks 8, 16, 24
measure: 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
timeFrame: Weeks 8, 16, 24
measure: 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
timeFrame: Baseline, Weeks 8, 16 and 24
measure: 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
timeFrame: Weeks 16 and 24
measure: 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
timeFrame: Weeks 16 and 24
measure: Change From Baseline in Modified vdH-S Erosion Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24
timeFrame: Baseline and Week 24
measure: 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
timeFrame: Baseline and Week 24
measure: Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24
timeFrame: Week 24
measure: Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24
timeFrame: Week 24
measure: Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24
timeFrame: Week 24
measure: Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24
timeFrame: Week 24
measure: Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24
timeFrame: Week 24
measure: Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24
timeFrame: Baseline and Weeks 8, 16 and 24
measure: Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24
timeFrame: Week 8, 16 and 24
measure: Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24
timeFrame: Week 8, 16 and 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24
timeFrame: Baseline, Weeks 8, 16 and 24
measure: Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24
timeFrame: Weeks 8, 16 and 24
measure: Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS
timeFrame: Baseline, Weeks 16 and 24
measure: Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index
timeFrame: Baseline, Weeks 16 and 24
measure: Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: ACR Components at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24
timeFrame: Week 52
measure: Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24
timeFrame: Week 52
measure: Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24
timeFrame: Week 52
measure: Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: 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
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: 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
timeFrame: Week 52
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52
timeFrame: Weeks 24, 28, 36, 44 and 52
measure: Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline
timeFrame: Weeks 24 and 52
measure: Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline
timeFrame: Weeks 24 and 52
measure: Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 24, 28, 36, 44 and 52
measure: Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Baseline, Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Baseline, Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Weeks 24 and 52
measure: 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
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in Modified vdH-S Score at Week 52
timeFrame: Baseline and Week 52
measure: Change in Total Modified vdH-S Score From Week 24 to Week 52
timeFrame: From Week 24 to Week 52
measure: Change From Baseline in Modified vdH-S Erosion Score at Week 52
timeFrame: Baseline and Week 52
measure: Change in Modified vdH-S Erosion Score From Week 24 to Week 52
timeFrame: From Week 24 to Week 52
measure: Change From Baseline in Modified vdH-S JSN Score at Week 52
timeFrame: Baseline and Week 52
measure: Change in Modified vdH-S JSN Score From Week 24 to Week 52
timeFrame: From Week 24 to Week 52
measure: 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
timeFrame: Baseline and Week 52
measure: Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52
timeFrame: Week 52
measure: Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52
timeFrame: Week 52
measure: Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52
timeFrame: Week 52
measure: Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52
timeFrame: Week 52
measure: Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52
timeFrame: Week 52
measure: Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in SF-36 PCS Score at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in SF-36 MCS Score at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52
timeFrame: Baseline, Weeks 24 and 52
measure: Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: ACR Components at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100
timeFrame: Baseline, Weeks 52, 68, 76, 84 and 100
measure: Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100
timeFrame: Baseline, Weeks 52, 68, 76, 84 and 100
measure: Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52
timeFrame: Week 100
measure: Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52
timeFrame: Week 100
measure: Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52
timeFrame: Week 100
measure: Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100
timeFrame: Baseline, Weeks 52, 68, 76, 84 and 100
measure: 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
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: 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
timeFrame: Week 100
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100
timeFrame: Baseline, Weeks 52, 68, 76, 84 and 100
measure: Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline
timeFrame: Weeks 52, 76, and 100
measure: Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline
timeFrame: Weeks 52, 76 and 100
measure: Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in PASDAS Score at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100
timeFrame: Weeks 52, 76 and 100
measure: Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100
timeFrame: Baseline, Weeks 52, 68, 76, 84 and 100
measure: Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100
timeFrame: Weeks 52, 68, 76, 84 and 100
measure: Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100
timeFrame: Weeks 52, 76 and 100
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100
timeFrame: Weeks 52, 76 and 100
measure: Percentage of Participants With VLDA at Weeks 52, 76 and 100
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Baseline, Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Baseline, Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Weeks 52, 76 and 100
measure: 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
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change in Modified vdH-S Score From Baseline to Week 100
timeFrame: Baseline to Week 100
measure: Change in Total Modified vdH-S Score From Week 52 to Week 100
timeFrame: From Week 52 to Week 100
measure: Change in Modified vdH-s Erosion Score From Baseline to Week 100
timeFrame: Baseline to Week 100
measure: Change in Modified vdH-s Erosion Score From Week 52 to Week 100
timeFrame: From Week 52 to Week 100
measure: Change in Modified vdH-s JSN Score From Baseline to Week 100
timeFrame: Baseline to Week 100
measure: Change in Modified vdH-s JSN Score From Week 52 to Week 100
timeFrame: From Week 52 to Week 100
measure: 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)
timeFrame: Baseline to Week 100
measure: Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score
timeFrame: Baseline to Week 100
measure: Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score
timeFrame: Baseline to Week 100
measure: Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score
timeFrame: Baseline to Week 100
measure: Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100
timeFrame: Baseline to Week 100
measure: Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100
timeFrame: Baseline to Week 100
measure: Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100
timeFrame: Baseline to Week 100
measure: Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100
timeFrame: Baseline, Weeks 24, 52, and 100
measure: Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100
timeFrame: Weeks 52, 76 and 100
measure: Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100
timeFrame: Weeks 52, 76 and 100
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100
timeFrame: Weeks 52, 76 and 100
measure: Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
measure: Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100
timeFrame: Baseline, Weeks 52, 76 and 100
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates PC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Danbury
country: United States
facility: Clinical Research Center of Connecticut
state: Connecticut
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Arthritis Consultants
state: Missouri
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Plovdiv
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
city: Ruse
country: Bulgaria
facility: Medical Center Teodora
city: Sofia
country: Bulgaria
facility: Diagnostic Consulting Center No 17
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: Medical Centre Synexus
city: Targovishte
country: Bulgaria
facility: MHAT-Targovishte, AD
city: Brno - Zidenice
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o.
city: Brno
country: Czechia
facility: Revmaclinic
city: Ostrava
country: Czechia
facility: MUDr. Rosypalova, s.r.o
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha
country: Czechia
facility: Revmatologicky institut
city: Uherske Hradiste
country: Czechia
facility: Medical Plus S.R.O.
city: Zlin
country: Czechia
facility: PV-Medical S.R.O
city: Parnu
country: Estonia
facility: Parnu Hospital
city: Tallinn
country: Estonia
facility: OU Innomedica
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Clinical Research Centre
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Riga
country: Latvia
facility: Derma Clinic Riga
city: Riga
country: Latvia
facility: J Kisis Ltd
city: Riga
country: Latvia
facility: Orto Clinic Ltd
city: Kaunas
country: Lithuania
facility: Vakk, Jsc
city: Siauliai
country: Lithuania
facility: Siauliai Republican Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Central Outpatient Clinic
city: Vilnius
country: Lithuania
facility: National Osteoporosis Centre
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Melaka
country: Malaysia
facility: Hospital Melaka
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy
city: Dabrowka
country: Poland
facility: NSZOZ Unica CR
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze
city: Gdansk
country: Poland
facility: Centrum Badań Klinicznych PI-House sp. z o.o.
city: Lodz
country: Poland
facility: Centrum Badawcze Wspolczesnej Terapii
city: Lodz
country: Poland
facility: Centrum Medyczne AMED oddzial w Lodzi
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED. S.C.
city: Olsztyn
country: Poland
facility: Etyka Osrodek Badan Klinicznych
city: Poznań
country: Poland
facility: Centrum Medyczne Hetmańska
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warsaw
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa Targowek
city: Wroclaw
country: Poland
facility: Wromedica
city: Wrocław
country: Poland
facility: Biogenes Sp. z o. o.
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Dermatovenerological Dispensary
city: Cherepovets
country: Russian Federation
facility: Medical and Sanitary Unit ''Severstal''
city: Ekaterinburg
country: Russian Federation
facility: Research Institute of Dermatovenerology, Immunology
city: Kemerovo
country: Russian Federation
facility: Regional Clinical Hospital for War Veterans
city: Kemerovo
country: Russian Federation
facility: Medical Centre Maximum Health
city: Korolev
country: Russian Federation
facility: Family polyclinic #4
city: Krasnodar
country: Russian Federation
facility: Krasnodar Clinical Dermatovenerologic Dispensary
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University
city: Lipetsk
country: Russian Federation
facility: Lipetsk Regional Dermatovenerological Dispensary
city: Moscow
country: Russian Federation
facility: Moscow State Medical and Stomatological University
city: Omsk
country: Russian Federation
facility: Clinical Diagnostic Center 'Ultramed'
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical University
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a.V.A.Baranov
city: Rostov
country: Russian Federation
facility: Rostov Regional Clinical Dermatovenerological Dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Dermatovenerological Dispensary
city: Saratov
country: Russian Federation
facility: Saratov Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: Smolensk regional hospital on Smolensk railway station
city: St-Petersburg
country: Russian Federation
facility: City Clinic №25 - City Rheumatology Centre
city: St-Petersburg
country: Russian Federation
facility: Leningrad region clinical hospital
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Dermatovenerological Dispensary
city: Tver
country: Russian Federation
facility: Regional Clinical Hospital
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital - G.G. Kuvatov
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital n.a. N.V. Solovyev
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #3
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #10
city: A Coruna
country: Spain
facility: Hosp. Univ. A Coruña
city: Barakaldo
country: Spain
facility: Hosp. Univ. de Cruces
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Cordoba
country: Spain
facility: Hosp. Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Málaga
country: Spain
facility: Hosp. Regional. Carlos Haya
city: Mérida
country: Spain
facility: Hosp. de Merida
city: San Sebastián de los Reyes
country: Spain
facility: H.U. Infanta Sofía
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Sevilla
country: Spain
facility: Hosp. Unv. de Valme
city: Valencia
country: Spain
facility: Hosp. Univ. Dr. Peset
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Vigo
country: Spain
facility: Hosp. Do Meixoeiro
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung Branch
city: Tainan
country: Taiwan
facility: National Cheng Kung University Medical Center
city: Taipei
country: Taiwan
facility: Chang Kung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, LinKou Branch
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Eskisehir
country: Turkey
facility: Osmangazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital
city: Cherkasy
country: Ukraine
facility: Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
city: Chernihiv
country: Ukraine
facility: Municipal health care institution Chernihiv Regional Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
city: Kharkiv
country: Ukraine
facility: Communal Institution of Health Kharkiv City multifield hospital №18
city: Kharkiv
country: Ukraine
facility: Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
city: Kharkiv
country: Ukraine
facility: State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
city: Kharkiv
country: Ukraine
facility: Municipal Institution Regional hospital-center of emergency care and disasters medicine
city: Kherson
country: Ukraine
facility: Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
city: Khmelnytsky
country: Ukraine
facility: Khmelnitckiy regional hospital
city: Kryvyi Rih
country: Ukraine
facility: City Clinical Hospital No. 2
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Kyiv
country: Ukraine
facility: Medical Center 'Consylium Medical'
city: Kyiv
country: Ukraine
facility: Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv Railway Station Clinical Hospital #2
city: Kyiv
country: Ukraine
facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University
city: Lviv
country: Ukraine
facility: Lviv Communcal City Clinical Hospital #4
city: Odessa
country: Ukraine
facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
city: Odessa
country: Ukraine
facility: Multidisciplinary Medical Center of Odessa National Medical University
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
city: Sumy
country: Ukraine
facility: Sumy State University
city: Ternopil
country: Ukraine
facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
city: Ternopil
country: Ukraine
facility: Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
city: Uzhgorod
country: Ukraine
facility: MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
city: Vinnytsya
country: Ukraine
facility: Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
city: Vinnytsya
country: Ukraine
facility: VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Clinical Hospital
city: Zhytomyr
country: Ukraine
facility: Municipal institution Central Clinical Hospital #1 Zhytomir
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Curtis JR, McInnes IB, Rahman P, Gladman DD, Peterson S, Agarwal P, Yang F, Kollmeier AP, Hsia EC, Shiff NJ, Zhou B, Han C, Shawi M, Tillett W, Mease PJ. The Effect of Guselkumab on Work Productivity in Biologic-Naive Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial. Adv Ther. 2022 Oct;39(10):4613-4631. doi: 10.1007/s12325-022-02270-7. Epub 2022 Aug 10.
citation: Curtis JR, McInnes IB, Rahman P, Gladman DD, Yang F, Peterson S, Agarwal P, Kollmeier AP, Hsia EC, Han C, Shiff NJ, Shawi M, Tillett W, Mease PJ. The Effect of Guselkumab on General Health State in Biologic-Naive Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial. Adv Ther. 2022 Oct;39(10):4632-4644. doi: 10.1007/s12325-022-02269-0. Epub 2022 Aug 10.
citation: Coates LC, Ritchlin CT, Gossec L, Helliwell PS, Rahman P, Kollmeier AP, Xu XL, Shawi M, Karyekar CS, Contre C, Noel W, Sheng S, Wang Y, Xu S, Mease PJ. Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis. Rheumatology (Oxford). 2023 Feb 1;62(2):606-616. doi: 10.1093/rheumatology/keac375.
citation: Schett G, Loza MJ, Palanichamy A, FitzGerald O, Ritchlin C, Bay-Jensen AC, Nielsen SH, Gao S, Hsia EC, Kollmeier AP, Xu XL, Baribaud F, Sweet K. Collagen Turnover Biomarkers Associate with Active Psoriatic Arthritis and Decrease with Guselkumab Treatment in a Phase 3 Clinical Trial (DISCOVER-2). Rheumatol Ther. 2022 Aug;9(4):1017-1030. doi: 10.1007/s40744-022-00444-x. Epub 2022 Mar 30.
citation: Ritchlin CT, Mease PJ, Boehncke WH, Tesser J, Schiopu E, Chakravarty SD, Kollmeier AP, Xu XL, Shawi M, Jiang Y, Sheng S, Wang Y, Xu S, Merola JF, McInnes IB, Deodhar A. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies. RMD Open. 2022 Mar;8(1):e002195. doi: 10.1136/rmdopen-2022-002195.
citation: Rahman P, Mease PJ, Helliwell PS, Deodhar A, Gossec L, Kavanaugh A, Kollmeier AP, Hsia EC, Zhou B, Lin X, Shawi M, Karyekar CS, Han C. Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response-results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis. Arthritis Res Ther. 2021 Jul 14;23(1):190. doi: 10.1186/s13075-021-02554-3.
citation: Sweet K, Song Q, Loza MJ, McInnes IB, Ma K, Leander K, Lakshminarayanan V, Franks C, Cooper P, Siebert S. Guselkumab induces robust reduction in acute phase proteins and type 17 effector cytokines in active psoriatic arthritis: results from phase 3 trials. RMD Open. 2021 May;7(2):e001679. doi: 10.1136/rmdopen-2021-001679.
citation: Rahman P, Ritchlin CT, Helliwell PS, Boehncke WH, Mease PJ, Gottlieb AB, Kafka S, Kollmeier AP, Hsia EC, Xu XL, Shawi M, Sheng S, Agarwal P, Zhou B, Ramachandran P, Zhuang Y, McInnes IB. Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis. J Rheumatol. 2021 Dec;48(12):1815-1823. doi: 10.3899/jrheum.201532. Epub 2021 May 1.
citation: McGonagle D, McInnes IB, Deodhar A, Schett G, Shawi M, Kafka S, Karyekar CS, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Agarwal P, Zhou B, Ritchlin CT, Rahman P, Mease PJ. Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies. Rheumatology (Oxford). 2021 Nov 3;60(11):5337-5350. doi: 10.1093/rheumatology/keab285.
citation: McInnes IB, Rahman P, Gottlieb AB, Hsia EC, Kollmeier AP, Chakravarty SD, Xu XL, Subramanian RA, Agarwal P, Sheng S, Jiang Y, Zhou B, Zhuang Y, van der Heijde D, Mease PJ. Efficacy and Safety of Guselkumab, an Interleukin-23p19-Specific Monoclonal Antibody, Through One Year in Biologic-Naive Patients With Psoriatic Arthritis. Arthritis Rheumatol. 2021 Apr;73(4):604-616. doi: 10.1002/art.41553. Epub 2021 Mar 17.
citation: Mease PJ, Rahman P, Gottlieb AB, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Agarwal P, Zhou B, Zhuang Y, van der Heijde D, McInnes IB; DISCOVER-2 Study Group. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1126-1136. doi: 10.1016/S0140-6736(20)30263-4. Epub 2020 Mar 13.