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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,054
Participants will receive guselkumab as SC injection.
Participants will receive matching placebo as SC injection.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response 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.
Time frame: At Week 24
Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at 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
Time frame: Baseline (after first administration of study drug) and Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rheumatology Associates
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research PLLC
Flagstaff, Arizona, United States
Arizona Arthritis & Rheumatology Associates PC
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Tucson, Arizona, United States
Advanced Medical Research
La Palma, California, United States
Rheumatology Center of San Diego
San Diego, California, United States
Medvin Clinical Research, Inc.
Whittier, California, United States
Heuer M.D. Research
Orlando, Florida, United States
The Arthritis Center, Inc.
Palm Harbor, Florida, United States
Forcare Clinical Research Inc
Tampa, Florida, United States
...and 270 more locations
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Reasonably Related Adverse Events (AEs)
Time frame: From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With TEAEs Leading to Discontinuation of Study Intervention
Time frame: From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Treatment Emergent Infections
Time frame: 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
Time frame: From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Clinical Laboratory Abnormalities
Time frame: 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
Time frame: From baseline (after first administration of study drug) up to 168 weeks
Serum Guselkumab Concentration
Time frame: From baseline (after first administration of study drug) up to 168 weeks
Number of Participants With Anti-guselkumab Antibodies
Time frame: From baseline (after first administration of study drug) up to 168 weeks