Trial · NCT03162796

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)

NCT03162796, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2020-10-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 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). Trials, record NCT03162796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03162796

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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)
NCT number: NCT03162796
Status: Completed
Phases: Phase 3
Enrollment: 383 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Arthritis, Psoriatic
Interventions: Guselkumab, Placebo
First posted: 2017-05-22
Last updated: 2021-02-03
Other registries' IDs: eudract:2016-001163-37
Results first posted: 2020-10-14

Source ClinicalTrials.gov

Registered outcomes100

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	Week 24	ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Baseline and Week 24	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Secondary	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24	Week 24	ACR 50 response was defined as greater than or equal to (\>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP).
Secondary	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	Week 24	A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Secondary	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16	Week 16	ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform task in that area), and C-reactive protein (CRP).
Secondary	Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24	Baseline and Week 24	The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Secondary	Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24	Week 24	ACR 70 response was defined as \>= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Secondary	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16	Week 16	ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Secondary	Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24	Baseline and Week 24	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Secondary	Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline	Week 24	Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI greater than (\>) 0.

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Outcomes100

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	Week 24	Analysis population is full analysis set 1 (FAS1). Participants who achieved ACR 20 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Baseline and Week 24	Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24	Week 24	Analysis population is FAS1. Participants who achieved ACR 50 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	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	Week 24	FAS1 among the participants with \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Participants who achieved psoriasis IGA response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16	Week 16	Analysis population is FAS1. Participants who achieved ACR 20 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24	Baseline and Week 24	Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24	Week 24	Analysis population is FAS1. Participants who achieved ACR 70 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16	Week 16	Analysis population is FAS1. Participants who achieved ACR 50 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24	Baseline and Week 24	Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR and imputed using MI.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline	Week 24	Analysis population is FAS1 among the participants with enthesitis (LEI) at baseline. Participants who achieved resolution of enthesitis at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.	percentage of participants	NUMBER

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Results by group1,631

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	Placebo	22.2		percentage of participants
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	Guselkumab 100 mg q8w	52.0		percentage of participants
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	Guselkumab 100 mg q4w	59.4		percentage of participants
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Placebo	-0.0743	95% Confidence Interval -0.1605 to 0.0119	units on a scale
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Guselkumab 100 mg q8w	-0.3225	95% Confidence Interval -0.4082 to -0.2369	units on a scale
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Guselkumab 100 mg q4w	-0.3968	95% Confidence Interval -0.4825 to -0.3112	units on a scale
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24	Placebo	8.7		percentage of participants
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24	Guselkumab 100 mg q8w	29.9		percentage of participants
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24	Guselkumab 100 mg q4w	35.9		percentage of participants
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	Placebo	15.4		percentage of participants

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Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Placebo Controlled Period: Week 0 - 24	STARTED	Placebo	126
Placebo Controlled Period: Week 0 - 24	STARTED	Guselkumab 100 mg q8w	127
Placebo Controlled Period: Week 0 - 24	STARTED	Guselkumab 100 mg q4w	128
Placebo Controlled Period: Week 0 - 24	COMPLETED	Placebo	114
Placebo Controlled Period: Week 0 - 24	COMPLETED	Guselkumab 100 mg q8w	123
Placebo Controlled Period: Week 0 - 24	COMPLETED	Guselkumab 100 mg q4w	125
Placebo Controlled Period: Week 0 - 24	NOT COMPLETED	Placebo	12
Placebo Controlled Period: Week 0 - 24	NOT COMPLETED	Guselkumab 100 mg q8w	4
Placebo Controlled Period: Week 0 - 24	NOT COMPLETED	Guselkumab 100 mg q4w	3
Active Treatment Period: Week 24 - 52	STARTED	Placebo	114

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Adverse events180

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Bronchitis	Infections and infestations	Placebo (CP)	1	126
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q8w (CP)	5	127
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q4w (CP)	1	128
other	Bronchitis	Infections and infestations	Placebo to Guselkumab 100 mg q4w (ACP Through Week 60)	3	114
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q8w (Through Week 60)	9	127
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q4w (Through Week 60)	2	128
other	Nasopharyngitis	Infections and infestations	Placebo (CP)	8	126
other	Nasopharyngitis	Infections and infestations	Guselkumab 100 mg q8w (CP)	16	127
other	Nasopharyngitis	Infections and infestations	Guselkumab 100 mg q4w (CP)	7	128
other	Nasopharyngitis	Infections and infestations	Placebo to Guselkumab 100 mg q4w (ACP Through Week 60)	13	114

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Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo (CP)	2	126
Total, all-cause mortality	Guselkumab 100 mg q8w (CP)	0	127
Total, all-cause mortality	Guselkumab 100 mg q4w (CP)	0	128
Total, all-cause mortality	Placebo to Guselkumab 100 mg q4w (ACP Through Week 60)	0	114
Total, all-cause mortality	Guselkumab 100 mg q8w (Through Week 60)	0	127
Total, all-cause mortality	Guselkumab 100 mg q4w (Through Week 60)	0	128
Total, other adverse events	Placebo (CP)	25	126
Total, other adverse events	Guselkumab 100 mg q8w (CP)	38	127
Total, other adverse events	Guselkumab 100 mg q4w (CP)	28	128
Total, other adverse events	Placebo to Guselkumab 100 mg q4w (ACP Through Week 60)	25	114

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Papers15

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32178765	DERIVED	PubMed
33822898	DERIVED	PubMed
33934076	DERIVED	PubMed
34011674	DERIVED	PubMed
34261541	DERIVED	PubMed
35296534	DERIVED	PubMed
35766811	DERIVED	PubMed
35768650	DERIVED	PubMed
36642439	DERIVED	PubMed
36995469	DERIVED	PubMed

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Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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