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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03162796




Registration number
NCT03162796
Ethics application status
Date submitted
19/05/2017
Date registered
22/05/2017
Date last updated
3/02/2021

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
Scientific 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 Including Those Previously Treated With Biologic Anti-TNF Alpha Agents
Secondary ID [1] 0 0
2016-001163-37
Secondary ID [2] 0 0
CR108218
Universal Trial Number (UTN)
Trial acronym
Discover-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo

Experimental: Group 1: Guselkumab - Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 48.

Experimental: Group 2: Guselkumab and Placebo - Participants will receive SC guselkumab 100 mg at Weeks 0 and 4, then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, and 44) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48) to maintain the blind.

Experimental: Group 3: Placebo Followed by Guselkumab - Participants will receive SC placebo q4w from Week 0 to Week 20, and will crossover at Week 24 to receive guselkumab 100 mg q4w from Week 24 through Week 48.


Treatment: Drugs: Guselkumab
Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.

Treatment: Drugs: Placebo
Participants will receive matching placebo as SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 Grade Reduction From Baseline) at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24
Timepoint [14] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [15] 0 0
Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24
Timepoint [15] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [16] 0 0
Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24
Timepoint [16] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [17] 0 0
ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24
Timepoint [17] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [18] 0 0
ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24
Timepoint [18] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [19] 0 0
ACR Component- C-reactive Protein (CRP) Through Week 24
Timepoint [19] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [20] 0 0
ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24
Timepoint [20] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [21] 0 0
Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24
Timepoint [21] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [22] 0 0
Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24
Timepoint [22] 0 0
Baseline, Week 4, 8, 12, 16, 20 and 24
Secondary outcome [23] 0 0
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline
Timepoint [23] 0 0
Week 4, 8, 12, 16, 20 and 24
Secondary outcome [24] 0 0
Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24
Timepoint [24] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [25] 0 0
Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24
Timepoint [25] 0 0
Week 4, 8, 12, 16, 20 and 24
Secondary outcome [26] 0 0
Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24
Timepoint [26] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [27] 0 0
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24
Timepoint [27] 0 0
Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [28] 0 0
Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline
Timepoint [28] 0 0
Weeks 4, 8, 16, and 24
Secondary outcome [29] 0 0
Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline
Timepoint [29] 0 0
Baseline, Weeks 4, 8, 16 and 24
Secondary outcome [30] 0 0
Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline
Timepoint [30] 0 0
Weeks 4, 8, 16 and 24
Secondary outcome [31] 0 0
Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline
Timepoint [31] 0 0
Baseline, Weeks 4, 8, 16 and 24
Secondary outcome [32] 0 0
Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24
Timepoint [32] 0 0
Baseline, Weeks 8, 16 and 24
Secondary outcome [33] 0 0
Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24
Timepoint [33] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [34] 0 0
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24
Timepoint [34] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [35] 0 0
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24
Timepoint [35] 0 0
Weeks 16 and Week 24
Secondary outcome [36] 0 0
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
Timepoint [36] 0 0
Weeks 8, 16 and 24
Secondary outcome [37] 0 0
Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline
Timepoint [37] 0 0
Baseline, Weeks 8, 16, and 24
Secondary outcome [38] 0 0
Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24
Timepoint [38] 0 0
Weeks 8, 16 and 24
Secondary outcome [39] 0 0
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24
Timepoint [39] 0 0
Weeks 16 and 24
Secondary outcome [40] 0 0
Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24
Timepoint [40] 0 0
Baseline, Weeks 4, 8, 12, 16, 20 and 24
Secondary outcome [41] 0 0
Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24
Timepoint [41] 0 0
Weeks 16 and 24
Secondary outcome [42] 0 0
Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
Timepoint [42] 0 0
Weeks 16 and 24
Secondary outcome [43] 0 0
Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
Timepoint [43] 0 0
Weeks 16 and 24
Secondary outcome [44] 0 0
Percentage of Participants Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
Timepoint [44] 0 0
Weeks 16 and 24
Secondary outcome [45] 0 0
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Timepoint [45] 0 0
Weeks 16 and 24
Secondary outcome [46] 0 0
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Timepoint [46] 0 0
Weeks 16 and 24
Secondary outcome [47] 0 0
Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Timepoint [47] 0 0
Weeks 16 and 24
Secondary outcome [48] 0 0
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
Timepoint [48] 0 0
Baseline, Weeks 16 and 24
Secondary outcome [49] 0 0
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24
Timepoint [49] 0 0
Baseline, Weeks 8, 16 and 24
Secondary outcome [50] 0 0
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24
Timepoint [50] 0 0
Baseline, Weeks 8, 16 and 24
Secondary outcome [51] 0 0
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24
Timepoint [51] 0 0
Baseline, Week 8, 16 and 24
Secondary outcome [52] 0 0
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24
Timepoint [52] 0 0
Weeks 8, 16 and 24
Secondary outcome [53] 0 0
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24
Timepoint [53] 0 0
Weeks 8, 16 and 24
Secondary outcome [54] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24
Timepoint [54] 0 0
Baseline, Weeks 8, 16 and 24
Secondary outcome [55] 0 0
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24
Timepoint [55] 0 0
Weeks 8, 16, and 24
Secondary outcome [56] 0 0
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24
Timepoint [56] 0 0
Baseline, Weeks 8, 16 and 24
Secondary outcome [57] 0 0
Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24
Timepoint [57] 0 0
Baseline and Week 24
Secondary outcome [58] 0 0
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24
Timepoint [58] 0 0
Week 24
Secondary outcome [59] 0 0
Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24
Timepoint [59] 0 0
Weeks 8, 16, and 24
Secondary outcome [60] 0 0
Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24
Timepoint [60] 0 0
Weeks 8, 16, and 24
Secondary outcome [61] 0 0
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52
Timepoint [61] 0 0
Weeks 24, 28, 36, 44 and 52
Secondary outcome [62] 0 0
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52
Timepoint [62] 0 0
Weeks 24, 28, 36, 44 and 52
Secondary outcome [63] 0 0
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52
Timepoint [63] 0 0
Weeks 24, 28, 36, 44 and 52
Secondary outcome [64] 0 0
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
Timepoint [64] 0 0
Baseline, Weeks 24, 28, 36, 44 and 52
Secondary outcome [65] 0 0
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52
Timepoint [65] 0 0
Baseline, Weeks 24, 28, 36, 44 and 52
Secondary outcome [66] 0 0
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
Timepoint [66] 0 0
Weeks 24, 28, 36, 44 and 52
Secondary outcome [67] 0 0
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52
Timepoint [67] 0 0
Baseline, Weeks 24, 28, 36, 44 and 52
Secondary outcome [68] 0 0
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52
Timepoint [68] 0 0
Weeks 24, 28, 36, 44 and 52
Secondary outcome [69] 0 0
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52
Timepoint [69] 0 0
Weeks 24, 28, 36, 44 and 52
Secondary outcome [70] 0 0
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
Timepoint [70] 0 0
Week 52
Secondary outcome [71] 0 0
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52
Timepoint [71] 0 0
Weeks 24, 28, 36, 44 and 52
Secondary outcome [72] 0 0
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52
Timepoint [72] 0 0
Baseline, Weeks 24, 28, 36, 44 and 52
Secondary outcome [73] 0 0
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 at Baseline
Timepoint [73] 0 0
Weeks 24 and 52
Secondary outcome [74] 0 0
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 at Baseline
Timepoint [74] 0 0
Weeks 24 and 52
Secondary outcome [75] 0 0
Change From Baseline in PASI Score at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
Timepoint [75] 0 0
Baseline, Weeks 24 and 52
Secondary outcome [76] 0 0
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 at Baseline
Timepoint [76] 0 0
Weeks 24 and 52
Secondary outcome [77] 0 0
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 at Baseline
Timepoint [77] 0 0
Weeks 24 and 52
Secondary outcome [78] 0 0
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 at Baseline
Timepoint [78] 0 0
Weeks 24 and 52
Secondary outcome [79] 0 0
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52
Timepoint [79] 0 0
Weeks 24, 36 and 52
Secondary outcome [80] 0 0
Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52
Timepoint [80] 0 0
Weeks 24, 36 and 52
Secondary outcome [81] 0 0
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52
Timepoint [81] 0 0
Weeks 24 and 52
Secondary outcome [82] 0 0
Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52
Timepoint [82] 0 0
Baseline, Weeks 24 and 52
Secondary outcome [83] 0 0
Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52
Timepoint [83] 0 0
Baseline, Weeks 24 and 52
Secondary outcome [84] 0 0
Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24
Timepoint [84] 0 0
Week 52
Secondary outcome [85] 0 0
Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24
Timepoint [85] 0 0
Week 52
Secondary outcome [86] 0 0
Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24
Timepoint [86] 0 0
Week 52
Secondary outcome [87] 0 0
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA
Timepoint [87] 0 0
Weeks 24 and 52
Secondary outcome [88] 0 0
Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline
Timepoint [88] 0 0
Weeks 24, 36, 44 and 52
Secondary outcome [89] 0 0
Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline
Timepoint [89] 0 0
Weeks 24, 36, 44 and 52
Secondary outcome [90] 0 0
Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline
Timepoint [90] 0 0
Baseline, Weeks 24, 36, 44 and 52
Secondary outcome [91] 0 0
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline
Timepoint [91] 0 0
Baseline, Weeks 24, 36, 44 and 52
Secondary outcome [92] 0 0
Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline
Timepoint [92] 0 0
Baseline, Weeks 24, 36, 44 and 52
Secondary outcome [93] 0 0
Percentage of Participants With an IGA Score of 0 (Cleared) or 1 (Cleared) at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
Timepoint [93] 0 0
Weeks 24 and 52
Secondary outcome [94] 0 0
Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52
Timepoint [94] 0 0
Baseline, Weeks 24, 36 and 52
Secondary outcome [95] 0 0
Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52
Timepoint [95] 0 0
Baseline, Weeks 24, 36 and 52
Secondary outcome [96] 0 0
Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52
Timepoint [96] 0 0
Baseline, Weeks 24, 36 and 52
Secondary outcome [97] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52
Timepoint [97] 0 0
Baseline, Weeks 24, 36 and 52
Secondary outcome [98] 0 0
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52
Timepoint [98] 0 0
Weeks 24, 36 and 52
Secondary outcome [99] 0 0
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52
Timepoint [99] 0 0
Baseline, Weeks 24, 36 and 52

Eligibility
Key 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 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 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
* 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 drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
* Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent [%] of the overall study population), and must document the reason for discontinuation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has other inflammatory diseases that might confound the evaluations of 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 ever received more than 2 anti-TNFalpha agents
* Has previously received any biologic treatment (other than anti-TNF alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
* Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
* Has received apremilast within 4 weeks prior to the first administration of study agent
* Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2019
Sample size
Target
Accrual to date
Final
383
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Barwon Rheumatology Services - Geelong
Recruitment hospital [2] 0 0
Southern Clinical Research - Hobart
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [5] 0 0
Eastern Health - Box Hill Hospital - Melbourne
Recruitment hospital [6] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
4558 - Maroochydore
Recruitment postcode(s) [5] 0 0
3128 - Melbourne
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
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Ternopil

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03162796