Arthritis, Psoriatic
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Interventions
DRUGGuselkumab
Participants will receive guselkumab as SC injection.
DRUGPlacebo
Participants will receive matching placebo as SC injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy * Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening * Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory * Have \>= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read * Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis * Have active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeter (cm) diameter or nail changes consistent with psoriasis
Exclusion criteria
* Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients * Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease * Has previously received any biologic treatment * Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor * Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From baseline (after first administration of study drug) up to 168 weeks | — |
| Number of Participants With Serious Adverse Events (SAEs) | From baseline (after first administration of study drug) up to 168 weeks | — |
| Number of Participants With Reasonably Related Adverse Events (AEs) | From baseline (after first administration of study drug) up to 168 weeks | — |
| Number of Participants With TEAEs Leading to Discontinuation of Study Intervention | From baseline (after first administration of study drug) up to 168 weeks | — |
| Number of Participants With Treatment Emergent Infections | From baseline (after first administration of study drug) up to 168 weeks | — |
| 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 | — |
| Number of Participants With Clinical Laboratory Abnormalities | From baseline (after first administration of study drug) up to 168 weeks | — |
| 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 | — |
| Serum Guselkumab Concentration | From baseline (after first administration of study drug) up to 168 weeks | — |
| Number of Participants With Anti-guselkumab Antibodies | From baseline (after first administration of study drug) up to 168 weeks | — |
Countries
Australia, Bosnia and Herzegovina, Bulgaria, Canada, China, Croatia, Czechia, Estonia, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Malaysia, Philippines, Poland, Russia, Serbia, Slovakia, Slovenia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Participant flow
Pre-assignment details
1054 participants were randomized, and all received study drug and were analyzed for safety (Safety Analysis Set). 5 Ukrainian sites were excluded from the main efficacy analysis (Modified FAS, N=1020), as they were unable to support key study operations due to the crisis in Ukraine and neighboring countries/territories beginning 2022-02-24. Results are currently reported until the primary completion date (30 December 2024). Results of remaining duration will be reported upon study completion.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 13.15 |
| Age, Customized 85 years and over | 0 Participants |
| Age, Customized Adults (18-64 years) | 311 Participants |
| Age, Customized From 65 to 84 years | 210 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 382 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 160 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 883 Participants |
| Region of Enrollment Australia | 3 Participants |
| Region of Enrollment Bosnia and Herzegovina | 25 Participants |
| Region of Enrollment Bulgaria | 95 Participants |
| Region of Enrollment Canada | 5 Participants |
| Region of Enrollment China | 27 Participants |
| Region of Enrollment Croatia | 8 Participants |
| Region of Enrollment Czech Republic | 26 Participants |
| Region of Enrollment Estonia | 10 Participants |
| Region of Enrollment Georgia | 33 Participants |
| Region of Enrollment Germany | 1 Participants |
| Region of Enrollment Greece | 1 Participants |
| Region of Enrollment Hungary | 25 Participants |
| Region of Enrollment Israel | 15 Participants |
| Region of Enrollment Italy | 7 Participants |
| Region of Enrollment Korea, South | 0 Participants |
| Region of Enrollment Latvia | 21 Participants |
| Region of Enrollment Lithuania | 54 Participants |
| Region of Enrollment Malaysia | 11 Participants |
| Region of Enrollment Philippines | 23 Participants |
| Region of Enrollment Poland | 90 Participants |
| Region of Enrollment Russian Federation | 55 Participants |
| Region of Enrollment Serbia | 75 Participants |
| Region of Enrollment Slovakia | 18 Participants |
| Region of Enrollment Slovenia | 2 Participants |
| Region of Enrollment Spain | 9 Participants |
| Region of Enrollment Taiwan | 3 Participants |
| Region of Enrollment Turkey | 0 Participants |
| Region of Enrollment Ukraine | 39 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 388 | 1 / 280 | 0 / 386 |
| other Total, other adverse events | 41 / 388 | 22 / 280 | 42 / 386 |
| serious Total, serious adverse events | 12 / 388 | 5 / 280 | 10 / 386 |
Outcome results
None listed