Trial · NCT03158285

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

NCT03158285, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2020-11-05

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. Trials, record NCT03158285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03158285

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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
NCT number: NCT03158285
Status: Completed
Phases: Phase 3
Enrollment: 741 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Arthritis, Psoriatic
Interventions: Guselkumab, Placebo
First posted: 2017-05-18
Last updated: 2026-06-02
Other registries' IDs: eudract:2016-001224-63
Results first posted: 2020-11-05

Source ClinicalTrials.gov

Registered outcomes209

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 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 Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline	Week 24	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 was defined as \>= 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 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 Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24	Baseline and Week 24	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
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\>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Secondary	Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline	Week 24	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Secondary	Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline	Baseline and Week 24	Enthesitis was assessed using the 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). Negative changes from baseline indicate improvement of enthesitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Secondary	Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline	Baseline and Week 24	The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.

1 to 10 of 209Source ClinicalTrials.gov

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Outcomes209

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 treatment failure (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 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 Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline	Week 24	FAS1 among participants with \>=3% BSA psoriatic involvement and an IGA score \>=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 before Week 16 or with missing data were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24	Baseline and Week 24	FAS1 for structural damage (FAS1-SD) included all participants who received at least 1 dose (complete/partial) of study agent according to randomized treatment group regardless of treatment actually received. Observed data were used regardless if 1 or more TF criteria were met. 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	FAS1 among participants with enthesitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with enthesitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline	Week 24	FAS1 among participants with dactylitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with dactylitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline	Baseline and Week 24	Analysis population is FAS1 among participants with enthesitis at baseline pooled from both CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline	Baseline and Week 24	Analysis population is FAS1 among participants with dactylitis at baseline pooled from both from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 209Source ClinicalTrials.gov

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Results by group2,681

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 to Guselkumab 100 mg q4w	32.9		percentage of participants
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	Guselkumab 100 mg q8w	64.1		percentage of participants
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	Guselkumab 100 mg q4w	63.7		percentage of participants
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Placebo to Guselkumab 100 mg q4w	-0.1300	95% Confidence Interval -0.1912 to -0.0687	units on a scale
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Guselkumab 100 mg q8w	-0.3672	95% Confidence Interval -0.4282 to -0.3062	units on a scale
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24	Guselkumab 100 mg q4w	-0.4004	95% Confidence Interval -0.4617 to -0.3390	units on a scale
Percentage of Participants Who Achieved an ACR 50 Response at Week 24	Placebo to Guselkumab 100 mg q4w	14.2		percentage of participants
Percentage of Participants Who Achieved an ACR 50 Response at Week 24	Guselkumab 100 mg q8w	31.5		percentage of participants
Percentage of Participants Who Achieved an ACR 50 Response at Week 24	Guselkumab 100 mg q4w	33.1		percentage of participants
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	Placebo to Guselkumab 100 mg q4w	19.1		percentage of participants

1 to 10 of 2,681Source ClinicalTrials.gov

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Participant flow33

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

Period	Milestone	Group	Participants
Placebo-controlled Period: Week 0 - 24	STARTED	Placebo to Guselkumab 100 mg q4w	246
Placebo-controlled Period: Week 0 - 24	STARTED	Guselkumab 100 mg q8w	248
Placebo-controlled Period: Week 0 - 24	STARTED	Guselkumab 100 mg q4w	245
Placebo-controlled Period: Week 0 - 24	Pooled Population: Enthesitis Assessment	Placebo to Guselkumab 100 mg q4w	255
Placebo-controlled Period: Week 0 - 24	Pooled Population: Enthesitis Assessment	Guselkumab 100 mg q8w	230
Placebo-controlled Period: Week 0 - 24	Pooled Population: Enthesitis Assessment	Guselkumab 100 mg q4w	243
Placebo-controlled Period: Week 0 - 24	Pooled Population: Dactylitis Assessment	Placebo to Guselkumab 100 mg q4w	154
Placebo-controlled Period: Week 0 - 24	Pooled Population: Dactylitis Assessment	Guselkumab 100 mg q8w	160
Placebo-controlled Period: Week 0 - 24	Pooled Population: Dactylitis Assessment	Guselkumab 100 mg q4w	159
Placebo-controlled Period: Week 0 - 24	COMPLETED	Placebo to Guselkumab 100 mg q4w	240

1 to 10 of 33Source ClinicalTrials.gov

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Adverse events450

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)	3	246
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q8w (CP)	1	248
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q4w (CP)	10	245
other	Bronchitis	Infections and infestations	Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)	7	238
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q8w (Through Week 112)	10	248
other	Bronchitis	Infections and infestations	Guselkumab 100 mg q4w (Through Week 112)	15	245
other	Nasopharyngitis	Infections and infestations	Placebo (CP)	9	246
other	Nasopharyngitis	Infections and infestations	Guselkumab 100 mg q8w (CP)	10	248
other	Nasopharyngitis	Infections and infestations	Guselkumab 100 mg q4w (CP)	12	245
other	Nasopharyngitis	Infections and infestations	Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)	9	238

1 to 10 of 450Source ClinicalTrials.gov

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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)	0	246
Total, all-cause mortality	Guselkumab 100 mg q8w (CP)	0	248
Total, all-cause mortality	Guselkumab 100 mg q4w (CP)	0	245
Total, all-cause mortality	Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)	1	238
Total, all-cause mortality	Guselkumab 100 mg q8w (Through Week 112)	0	248
Total, all-cause mortality	Guselkumab 100 mg q4w (Through Week 112)	0	245
Total, other adverse events	Placebo (CP)	30	246
Total, other adverse events	Guselkumab 100 mg q8w (CP)	42	248
Total, other adverse events	Guselkumab 100 mg q4w (CP)	52	245
Total, other adverse events	Placebo to Guselkumab 100 mg q4w (After CP Through Week 112)	48	238

1 to 10 of 18Source ClinicalTrials.gov

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Papers28

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32178766	DERIVED	PubMed
33043600	DERIVED	PubMed
33822898	DERIVED	PubMed
33934076	DERIVED	PubMed
34011674	DERIVED	PubMed
34261541	DERIVED	PubMed
35296534	DERIVED	PubMed
35352313	DERIVED	PubMed
35766811	DERIVED	PubMed
35947348	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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