Trial · NCT04882098
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
NCT04882098, Phase 3, Active not recruiting, Janssen Research & Development, LLC; results first posted 2026-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Guselkumab in Participants With Active Psoriatic Arthritis. Trials, record NCT04882098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04882098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Guselkumab in Participants With Active Psoriatic Arthritis
- NCT number
- NCT04882098
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,054 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Arthritis, Psoriatic
- Interventions
- Guselkumab, Placebo
- First posted
- 2021-05-11
- Last updated
- 2026-11-04
- Other registries' IDs
- eudract:2020-004981-20
- Results first posted
- 2026-02-04
Source ClinicalTrials.gov
Registered outcomes12
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 | At Week 24 | ACR 20 response: \>=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, \>=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD. |
| Secondary | Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24 | Baseline (after first administration of study drug) and Week 24 | Modified vdH-S score was sum of erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score was total erosion severity in 40 joints of 2 hands and 12 joints of 2 feet, maximum erosion score=320. Each hand joint was scored on 0 to 5 with 0 =no erosion, 5 =complete collapse of bone. Foot joint was scored on 0 to 10, 0 =no erosion, 10 =complete collapse of bone. JSN score was total JSN score in same 52 joints, each joint scored on 0 to 4 with 0 indicating no JSN, and 4 indicating absence of joint space, maximum JSN score=208. Maximum modified vdH-S score=528. Higher score =severe structural destruction and complete loss of joint spaces. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With Reasonably Related Adverse Events (AEs) | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With TEAEs Leading to Discontinuation of Study Intervention | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With Treatment Emergent Infections | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With Injection-site Reactions Leading to Discontinuation of Study Intervention | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With Clinical Laboratory Abnormalities | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Toxicity Grade Laboratory Values | From baseline (after first administration of study drug) up to 168 weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 | At Week 24 | Analysis population is Modified FAS (mFAS). Participants who achieved ACR 20 response at Week 24 and did not meet any Composite Strategy ICEs before Week 24 were considered as responders. Participants who met any Composite Strategy ICEs before Week 24 were considered non-responders. Participants who met Hypothetical Strategy ICEs, or missed data due to ND/MD, had affected visits imputed using multiple imputation. Other missing data were imputed as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24 | Baseline (after first administration of study drug) and Week 24 | Modified full analysis set included all participants who were randomized, excluding participants from Ukrainian sites rendered unable to support key study operations due to major disruption. Participants who met Hypothetical Strategy ICEs had affected visits imputed using multiple imputation. Missing data were also imputed using multiple imputation. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From baseline (after first administration of study drug) up to 168 weeks | |||
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | From baseline (after first administration of study drug) up to 168 weeks | |||
| SECONDARY | Number of Participants With Reasonably Related Adverse Events (AEs) | From baseline (after first administration of study drug) up to 168 weeks | |||
| SECONDARY | Number of Participants With TEAEs Leading to Discontinuation of Study Intervention | From baseline (after first administration of study drug) up to 168 weeks | |||
| SECONDARY | Number of Participants With Treatment Emergent Infections | From baseline (after first administration of study drug) up to 168 weeks | |||
| SECONDARY | Number of Participants With Injection-site Reactions Leading to Discontinuation of Study Intervention | From baseline (after first administration of study drug) up to 168 weeks | |||
| SECONDARY | Number of Participants With Clinical Laboratory Abnormalities | From baseline (after first administration of study drug) up to 168 weeks | |||
| SECONDARY | Number of Participants With Maximum Common Terminology Criteria for Adverse Events (CTCAE) Toxicity Grade Laboratory Values | From baseline (after first administration of study drug) up to 168 weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | Group 1: Guselkumab 100 mg q8w | 68.3 | percentage of participants | ||
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | Group 2: Guselkumab 100 mg q4w | 66.6 | percentage of participants | ||
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | Group 3: Placebo Followed by Guselkumab | 47.0 | percentage of participants | ||
| Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24 | Group 1: Guselkumab 100 mg q8w | 0.54 | 95% Confidence Interval 0.14 to 0.95 | Score on a scale | |
| Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24 | Group 2: Guselkumab 100 mg q4w | 0.55 | 95% Confidence Interval 0.10 to 1.00 | Score on a scale | |
| Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24 | Group 3: Placebo Followed by Guselkumab | 1.35 | 95% Confidence Interval 0.94 to 1.75 | Score on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Guselkumab 100 mg q8w | 388 | |
| Overall Study | STARTED | Group 2: Guselkumab 100 mg q4w | 280 | |
| Overall Study | STARTED | Group 3: Placebo Followed by Guselkumab | 386 | |
| Overall Study | Modified Full Analysis Set | Group 1: Guselkumab 100 mg q8w | 371 | |
| Overall Study | Modified Full Analysis Set | Group 2: Guselkumab 100 mg q4w | 273 | |
| Overall Study | Modified Full Analysis Set | Group 3: Placebo Followed by Guselkumab | 376 | |
| Overall Study | COMPLETED | Group 1: Guselkumab 100 mg q8w | 370 | |
| Overall Study | COMPLETED | Group 2: Guselkumab 100 mg q4w | 270 | |
| Overall Study | COMPLETED | Group 3: Placebo Followed by Guselkumab | 372 | |
| Overall Study | NOT COMPLETED | Group 1: Guselkumab 100 mg q8w | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events93
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 | Events |
|---|---|---|---|---|---|---|
| other | Covid-19 | Infections and infestations | Group 1: Guselkumab 100 mg q8w | 22 | 388 | |
| other | Covid-19 | Infections and infestations | Group 2: Guselkumab 100 mg q4w | 8 | 280 | |
| other | Covid-19 | Infections and infestations | Group 3: Placebo Followed by Guselkumab | 20 | 386 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Group 1: Guselkumab 100 mg q8w | 20 | 388 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Group 2: Guselkumab 100 mg q4w | 15 | 280 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Group 3: Placebo Followed by Guselkumab | 22 | 386 | |
| serious | Arteriosclerosis Coronary Artery | Cardiac disorders | Group 1: Guselkumab 100 mg q8w | 1 | 388 | |
| serious | Arteriosclerosis Coronary Artery | Cardiac disorders | Group 2: Guselkumab 100 mg q4w | 0 | 280 | |
| serious | Arteriosclerosis Coronary Artery | Cardiac disorders | Group 3: Placebo Followed by Guselkumab | 0 | 386 | |
| serious | Atrial Fibrillation | Cardiac disorders | Group 1: Guselkumab 100 mg q8w | 0 | 388 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Guselkumab 100 mg q8w | 0 | 388 |
| Total, all-cause mortality | Group 2: Guselkumab 100 mg q4w | 1 | 280 |
| Total, all-cause mortality | Group 3: Placebo Followed by Guselkumab | 0 | 386 |
| Total, other adverse events | Group 1: Guselkumab 100 mg q8w | 41 | 388 |
| Total, other adverse events | Group 2: Guselkumab 100 mg q4w | 22 | 280 |
| Total, other adverse events | Group 3: Placebo Followed by Guselkumab | 42 | 386 |
| Total, serious adverse events | Group 1: Guselkumab 100 mg q8w | 12 | 388 |
| Total, serious adverse events | Group 2: Guselkumab 100 mg q4w | 5 | 280 |
| Total, serious adverse events | Group 3: Placebo Followed by Guselkumab | 10 | 386 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36627711 | DERIVED |
Source PubMed
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04882098
GET https://conductscience.org/api/trials/v1/NCT04882098/events?page=2