Trial · NCT04882098
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 | |
| Secondary | Serum Guselkumab Concentration | From baseline (after first administration of study drug) up to 168 weeks | |
| Secondary | Number of Participants With Anti-guselkumab Antibodies | From baseline (after first administration of study drug) up to 168 weeks |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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