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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	9 January 2023
Main ID:	NCT03158285
Date of registration:	16/05/2017
Prospective Registration:	Yes
Primary sponsor:	Janssen Research & Development, LLC
Public title:	A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
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
Date of first enrolment:	July 12, 2017
Target sample size:	741
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03158285
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase:	Phase 3

Countries of recruitment
Bulgaria	Czechia	Estonia	Greece	Latvia	Lithuania	Malaysia	Poland
Portugal	Romania	Russian Federation	South Africa	Spain	Taiwan	Turkey	Ukraine
United States

Contacts

Name:	Janssen Research & Development, LLC Clinical Trial
Address:
Telephone:
Email:
Affiliation:	Janssen Research & Development, LLC

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Psoriatic

Intervention(s)

Drug: Guselkumab

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline [Time Frame: Baseline and Week 24]

Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 [Time Frame: Baseline, Weeks 16 and 24]

Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline [Time Frame: Baseline, Weeks 2, 4, 8, 16 and 24]

Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 [Time Frame: Baseline, Weeks 52, 68, 76, 84 and 100]

Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

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 [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline [Time Frame: Baseline, Weeks 2, 4, 8, 16 and 24]

ACR Components at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline [Time Frame: Baseline, Weeks 52, 76 and 100]

ACR Components at Weeks 52, 68, 76, 84 and 100 [Time Frame: Weeks 52, 68, 76, 84 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 [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline [Time Frame: Baseline and Week 24]

Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index [Time Frame: Baseline, Weeks 16 and 24]

Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

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 [Time Frame: Baseline, Weeks 16 and 24]

Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 [Time Frame: Baseline, 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 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 [Time Frame: Baseline, Weeks 16 and 24]

Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 [Time Frame: Baseline, Weeks 52, 68, 76, 84 and 100]

Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24]

Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 [Time Frame: 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 [Time Frame: Baseline, Weeks 24 and 52]

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 [Time Frame: Week 8, 16 and 24]

Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 [Time Frame: Baseline, Weeks 52, 68, 76, 84 and 100]

Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Modified vdH-S Erosion Score at Week 52 [Time Frame: Baseline and Week 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 [Time Frame: Baseline and Week 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 [Time Frame: Baseline, Weeks 24 and 52]

Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 [Time Frame: Baseline, Weeks 16 and 24]

Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS [Time Frame: Baseline, Weeks 16 and 24]

Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 [Time Frame: Baseline, Weeks 52, 68, 76, 84 and 100]

Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 [Time Frame: Baseline, Weeks 16 and 24]

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 [Time Frame: Weeks 52, 76 and 100]

Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 [Time Frame: Baseline, Weeks 16 and 24]

Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 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 [Time Frame: Weeks 52, 68, 76, 84 and 100]

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 [Time Frame: Baseline, Weeks 8, 16 and 24]

Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change in Modified vdH-s Erosion Score From Week 52 to Week 100 [Time Frame: From Week 52 to Week 100]

Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 [Time Frame: Baseline, Weeks 24, 28, 36, 44 and 52]

Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

Percentage of Participants Who Achieved ACR 20 Response Through Week 24 [Time Frame: Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved ACR 70 Response Through Week 24 [Time Frame: 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 [Time Frame: Baseline, Weeks 8, 16 and 24]

Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 [Time Frame: Baseline, Weeks 16 and 24]

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 [Time Frame: Weeks 24 and 52]

Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Modified vdH-S Score at Week 52 [Time Frame: Baseline and Week 52]

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 [Time Frame: 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 [Time Frame: Weeks 52, 76 and 100]

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 [Time Frame: Baseline and Week 24]

Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 [Time Frame: Weeks 2, 4, 8, 12, 16, 20 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 [Time Frame: Weeks 8, 16, 24]

Change in Modified vdH-s JSN Score From Week 52 to Week 100 [Time Frame: From Week 52 to Week 100]

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

Change From Baseline in Modified vdH-S Erosion Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Modified vdH-S JSN Score at Week 52 [Time Frame: Baseline and Week 52]

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

Change in Modified vdH-s Erosion Score From Baseline to Week 100 [Time Frame: Baseline to Week 100]

Change in Modified vdH-S JSN Score From Week 24 to Week 52 [Time Frame: From Week 24 to Week 52]

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 [Time Frame: Baseline, Weeks 52, 76 and 100]

Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 [Time Frame: Week 24]

Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 [Time Frame: Week 52]

Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 [Time Frame: Baseline and Weeks 8, 16 and 24]

Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 [Time Frame: Weeks 52, 76 and 100]

Change in Modified vdH-s JSN Score From Baseline to Week 100 [Time Frame: Baseline to Week 100]

Change in Total Modified vdH-S Score From Week 24 to Week 52 [Time Frame: From Week 24 to Week 52]

Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score [Time Frame: Baseline to Week 100]

Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 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 [Time Frame: Weeks 24 and 52]

Change in Total Modified vdH-S Score From Week 52 to Week 100 [Time Frame: From Week 52 to Week 100]

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 [Time Frame: Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 [Time Frame: Weeks 52, 68, 76, 84 and 100]

Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 [Time Frame: Baseline, Weeks 24 and 52]

Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 [Time Frame: Baseline, Weeks 52, 68, 76, 84 and 100]

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 [Time Frame: Week 24]

Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 [Time Frame: Baseline, Weeks 52, 76 and 100]

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 [Time Frame: Weeks 8, 16 and 24]

Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 [Time Frame: Weeks 52, 76 and 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) [Time Frame: Baseline to Week 100]

Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24]

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 [Time Frame: Weeks 52, 76 and 100]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Weeks 52, 76 and 100]

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 [Time Frame: Weeks 8, 16 and 24]

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

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 [Time Frame: Weeks 8, 16, 24]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 [Time Frame: Weeks 24, 28, 36, 44 and 52]

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 [Time Frame: Week 8, 16 and 24]

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 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 [Time Frame: Weeks 52, 68, 76, 84 and 100]

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 [Time Frame: Week 16]

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 [Time Frame: Weeks 24 and 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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 [Time Frame: Weeks 52, 68, 76, 84 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 [Time Frame: Week 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 24 and 52 [Time Frame: Weeks 24 and 52]

Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 [Time Frame: Baseline and Week 24]

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 [Time Frame: Week 16]

Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 [Time Frame: Week 52]

Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 [Time Frame: Weeks 52, 68, 76, 84 and 100]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Weeks 16 and 24]

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 [Time Frame: 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 [Time Frame: Week 52]

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 [Time Frame: Weeks 16 and 24]

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 [Time Frame: Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 [Time Frame: Weeks 52, 68, 76, 84 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 [Time Frame: Weeks 52, 76 and 100]

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 [Time Frame: Weeks 24 and 52]

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 [Time Frame: Weeks 52, 76 and 100]

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 [Time Frame: Weeks 24 and 52]

Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 [Time Frame: Week 52]

Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 [Time Frame: Baseline and Week 52]

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 [Time Frame: Week 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 52, 76 and 100 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52 [Time Frame: Week 52]

Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline [Time Frame: Week 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 [Time Frame: Weeks 16 and 24]

Percentage of Participants Who Achieved ACR 50 Response Through Week 24 [Time Frame: Weeks 2, 4, 8, 12, 16, 20 and 24]

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 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24 [Time Frame: Week 24]

Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52 [Time Frame: Week 100]

Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 [Time Frame: Week 24]

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 [Time Frame: Weeks 24 and 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 [Time Frame: Week 100]

Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 [Time Frame: Week 52]

Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score [Time Frame: Baseline to Week 100]

Percentage of Participants With VLDA at Weeks 52, 76 and 100 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100 [Time Frame: Baseline to Week 100]

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 [Time Frame: Weeks 16 and 24]

Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 [Time Frame: Week 52]

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 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline [Time Frame: Weeks 2, 4, 8, 16 and 24]

Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 [Time Frame: Weeks 52, 68, 76, 84 and 100]

Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24 [Time Frame: Week 24]

Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 [Time Frame: Baseline, Weeks 24, 52, and 100]

Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline [Time Frame: Week 24]

Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline [Time Frame: Weeks 24 and 52]

Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline [Time Frame: Weeks 52, 76, and 100]

Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline [Time Frame: Weeks 24 and 52]

Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline [Time Frame: Weeks 2, 4, 8, 16 and 24]

Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24 [Time Frame: Week 24]

Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100 [Time Frame: Baseline to Week 100]

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

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 [Time Frame: Baseline, Weeks 24 and 52]

Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 [Time Frame: Baseline, Weeks 8, 16 and 24]

Change in Modified vdH-S Erosion Score From Week 24 to Week 52 [Time Frame: From Week 24 to Week 52]

Change in Modified vdH-S Score From Baseline to Week 100 [Time Frame: Baseline to 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 [Time Frame: Weeks 52, 68, 76, 84 and 100]

Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 [Time Frame: Weeks 2, 4, 8, 12, 16, 20 and 24]

Percentage of Participants Who Achieved an ACR 50 Response at Week 24 [Time Frame: Week 24]

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 [Time Frame: Weeks 52, 76 and 100]

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 [Time Frame: Weeks 16 and 24]

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 [Time Frame: Weeks 24 and 52]

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 [Time Frame: Weeks 52, 76 and 100]

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 [Time Frame: Week 24]

Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52 [Time Frame: Week 100]

Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 [Time Frame: Week 24]

Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score [Time Frame: Baseline to Week 100]

Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 [Time Frame: Weeks 24 and 52]

Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100 [Time Frame: Baseline to Week 100]

Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52 [Time Frame: Week 52]

Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52 [Time Frame: Week 52]

Secondary ID(s)

CNTO1959PSA3002

2016-001224-63

CR108219

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	05/11/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT03158285

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