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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PSA3005 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-000482-32 | EudraCT Number | ||
| 2023-504715-33-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Guselkumab and Placebo | Experimental | Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. |
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| Group 2: Guselkumab | Experimental | Participants will receive guselkumab SC. |
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| Group 3: Placebo Followed by Guselkumab | Experimental | Participants will receive placebo SC and will cross over to receive guselkumab SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Participants will receive guselkumab as SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at 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. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Psoriasis Response of Investigator's Global Assessment (IGA) Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among the Participants With >=3 Percent(%) Body Surface Area (BSA) | A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and greater than equal to (>=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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Associates | Mountain Brook | Alabama | 35223 | United States | ||
| Arizona Arthritis and Rheumatology Research PLLC 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38773563 | Derived | Ogdie A, Merola JF, Mease PJ, Ritchlin CT, Scher JU, Lafferty KP, Chan D, Chakravarty SD, Langholff W, Wang Y, Choi O, Krol Y, Gottlieb AB. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study. BMC Rheumatol. 2024 May 21;8(1):20. doi: 10.1186/s41927-024-00386-7. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Followed by Guselkumab 100 mg | Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg SC injections q4w from Week 24 through Week 100. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2024 | Oct 27, 2025 |
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|
| Placebo | Drug | Participants will receive matching placebo as SC injection. |
|
| At Week 24 |
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline. | At Week 24 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 | The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 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. | Baseline (pre dose Week 0) and Week 24 |
| Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. | Baseline (pre dose Week 0) and Week 24 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. | Baseline (pre dose Week 0) and Week 24 |
| Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24 | MDA is a measure that defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1). | At Week 24 |
| Percentage of Participants Who Achieved ACR 20 Response at Week 16 | 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. | At Week 16 |
| Percentage of Participants Who Achieved ACR 50 Response at Week 16 | ACR 50 response: >=50% 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 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. | At Week 16 |
| Percentage of Participants Who Achieved ACR 50 Response at Week 24 | ACR 50 response: >=50% 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 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. | At Week 24 |
| Percentage of Participants Who Achieved ACR 70 Response at Week 24 | ACR 70 response: >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% 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. | At Week 24 |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | From first administration of study drug (Week 0) up to Week 112 |
| Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | From first administration of study drug (Week 0) up to Week 112 |
| Percentage of Participants With Treatment Emergent Related AEs (TERAEs) | From first administration of study drug (Week 0) up to Week 112 |
| Treatment Emergent AEs Leading to Discontinuation of Study Intervention | From first administration of study drug (Week 0) up to Week 112 |
| Percentage of Participants With Infections | From first administration of study drug (Week 0) up to Week 112 |
| Percentage of Participants With Injection-site Reactions | From first administration of study drug (Week 0) up to Week 112 |
| Percentage of Participants With Infusion Related Reactions | From first administration of study drug (Week 0) up to Week 112 |
| Number of Participants With Post-baseline Laboratory Abnormalities With Maximum Toxicity Grade Greater Than or Equal to >=3 Based on Common Terminology Criteria for Adverse Events (CTCAE) | From first administration of study drug (Week 0) up to Week 112 |
| Serum Guselkumab Concentration Over Time | Serum concentrations of guselkumab over time was reported. | At Weeks 0, 4, 8, 12, 16, 20,and 24 |
| Number of Participants With Antibodies to Guselkumab | Number of participants with antibodies to guselkumab (ADA) were reported. A validated immunoassay was used to detect ADA. | Baseline (pre dose Week 0) up to Week 24 |
| Avondale |
| Arizona |
| 85392 |
| United States |
| Arizona Arthritis and Rheumatology Research PLLC 3 | Flagstaff | Arizona | 86001-6218 | United States |
| Arizona Arthritis and Rheumatology Research PLLC | Mesa | Arizona | 85210 | United States |
| Arizona Arthritis and Rheumatology Research PLLC 1 | Phoenix | Arizona | 85032 | United States |
| Arizona Arthritis and Rheumatology Associates | Sun City | Arizona | 85351 | United States |
| Southern Arizona VA Healthcare System | Tucson | Arizona | 85723 | United States |
| Unity Health-White County Medical Center | Searcy | Arkansas | 72143 | United States |
| Newport Huntington Medical Group | Huntington Beach | California | 92648 | United States |
| Medvin Clinical Research 2 | Thousand Oaks | California | 91360 | United States |
| Medvin Clinical Research | Tujunga | California | 91042 | United States |
| Clinical Research Center of Connecticut | Danbury | Connecticut | 06810 | United States |
| Bay Pines VA Healthcare System | Bay Pines | Florida | 33744 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Omega Research Consultants | DeBary | Florida | 32713 | United States |
| Advanced Clinical Research of Orlando | Ocoee | Florida | 34761 | United States |
| Integral Rheumatology And Immunology Specialists | Plantation | Florida | 33324 | United States |
| Clinical Research of West Florida 1 | Tampa | Florida | 33606 | United States |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Clinic of Robert Hozman | Skokie | Illinois | 60076 | United States |
| The Arthritis and Diabetes Clinic | Monroe | Louisiana | 71203 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Klein And Associates M D P A | Hagerstown | Maryland | 21740 | United States |
| Great Lakes Center of Rheumatology | Lansing | Michigan | 48911 | United States |
| Arthritis and Rheumatology Center of MI | Okemos | Michigan | 48864 | United States |
| Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | 48081 | United States |
| St. Paul Rheumatology P A | Eagan | Minnesota | 55121 | United States |
| Arthritis Consultants | St Louis | Missouri | 63141 | United States |
| Arthritis Rheumatic And Back Disease Associates | Voorhees Township | New Jersey | 08043 | United States |
| Albuquerque Center for Rheumatology | Albuquerque | New Mexico | 87102 | United States |
| Arthritis and Osteoperosis Associates of New Mexico | Las Cruces | New Mexico | 88011 | United States |
| Buffalo Rheumatology and Medicine PLLC | Orchard Park | New York | 14127 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28211 | United States |
| STAT Research, Inc. | Vandalia | Ohio | 45377 | United States |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| Rheumatology Associates of Oklahoma | Oklahoma City | Oklahoma | 73116 | United States |
| Dr. Ramesh Gupta | Memphis | Tennessee | 38119 | United States |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | United States |
| Adriana Pop Moody MD Clinic PA | Corpus Christi | Texas | 78404 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Precision Comprehensive Clinical Research Solutions 1 | Fort Worth | Texas | 76107 | United States |
| West Texas Clinical Research | Lubbock | Texas | 79424 | United States |
| Southwest Rheumatology Research LLC | Mesquite | Texas | 75150 | United States |
| Texas Rheumatology Care | Plano | Texas | 75024 | United States |
| Advanced Rheumatology of Houston | The Woodlands | Texas | 77382 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Arthritis And Osteoporosis Clinic | Waco | Texas | 76710 | United States |
| Arthritis Northwest PLLC 1 | Spokane | Washington | 99204 | United States |
| Rheumatology and Pulmonary Clinic | Beckley | West Virginia | 25801 | United States |
| Cosultorios Reumatologógicos Pampa | Buenos Aires | 1428 | Argentina |
| OMI | Buenos Aires | C1015ABO | Argentina |
| CIPREC | Buenos Aires | C1061AAS | Argentina |
| Centro Privado de Medicina Familiar | Buenos Aires | C1417EYG | Argentina |
| Hospital Central Militar Cirujano Mayor Dr Cosme Argerich | Buenos Aires | C1426BOS | Argentina |
| Instituto de Reumatología Mendoza | Mendoza | M5631AHF | Argentina |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | T4000AXL | Argentina |
| Southern Clinical Research | Hobart | 7000 | Australia |
| Liverpool Hospital | Liverpool | 2170 | Australia |
| Skin Health Institute Inc. | Melbourne | 3053 | Australia |
| Eastern Health - Box Hill Hospital | Melbourne | 3128 | Australia |
| UMHAT 'Dr. Georgi Stranski', EAD | Pleven | 5804 | Bulgaria |
| Medical Center Unimed Plovdiv | Plovdiv | 4001 | Bulgaria |
| UMHAT Kaspela | Plovdiv | 4001 | Bulgaria |
| Diagnosis-consulting centre-1 | Rousse | 7002 | Bulgaria |
| Military Medical Academy | Sofia | 1606 | Bulgaria |
| UMHAT St. Ivan Rilski | Sofia | 1612 | Bulgaria |
| ASIMP Rheumatology Centre St Irina EOOD | Sofia | 1750 | Bulgaria |
| University Multiprofile Hospital Sofiamed Sofia | Sofia | 1770 | Bulgaria |
| Medical Centre Synexus | Sofia | 1794 | Bulgaria |
| RHEUMA s r o | Břeclav | 690 02 | Czechia |
| L K N Arthrocentrum | Hlučín | 748 01 | Czechia |
| MUDr Rosypalova s r o | Ostrava | 70800 | Czechia |
| Arthrohelp S.R.O. | Pardubice | 53002 | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Medical Plus S R O | Uherské Hradiště | 68601 | Czechia |
| PV Medical S R O | Zlín | 76001 | Czechia |
| Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz | Budapest | 1027 | Hungary |
| Uno Medical Trials Ltd. | Budapest | 1152 | Hungary |
| Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház | Debrecen | 4031 | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Gyula | 5700 | Hungary |
| Pest Megyei Flor Ferenc Korhaz | Kistarcsa | 2143 | Hungary |
| Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ | Szeged | 6725 | Hungary |
| Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz | Székesfehérvár | H-8000 | Hungary |
| Vital Medical Center Orvosi es Fogaszati Kozpont | Veszprém | 8200 | Hungary |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Carmel Medical Center | Haifa | 34362 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Hospital Selayang | Batu Caves | 68100 | Malaysia |
| Hospital Pulau Pinang | George Town | 10990 | Malaysia |
| Hospital Raja Permaisuri Bainun | Ipoh | 30450 | Malaysia |
| Hospital Tuanku Jaafar | Seremban | 70300 | Malaysia |
| Nzoz Bif Med | Bytom | 41 902 | Poland |
| Centrum Kliniczno Badawcze | Elblag | 82-300 | Poland |
| Malopolskie Badania Kliniczne Sp z o o | Krakow | 30 002 | Poland |
| Malopolskie Centrum Kliniczne | Krakow | 30 149 | Poland |
| Centrum Medyczne Promed | Krakow | 31-513 | Poland |
| Dermed Centrum Medyczne Sp z o o | Lodz | 90-265 | Poland |
| Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna | Lodz | 90-338 | Poland |
| NZOZ Lecznica MAK MED S C | Nadarzyn | 05-830 | Poland |
| Twoja Przychodnia - Centrum Medyczne Nowa Sol | Nowa Sól | 67-100 | Poland |
| Twoja Przychodnia PCM | Poznan | 60 324 | Poland |
| Centrum Medyczne | Poznan | 61 113 | Poland |
| Lubelskie Centrum Diagnostyczne | Świdnik | 21 040 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00-874 | Poland |
| Rheuma Medicus Sp z o o | Warsaw | 02 118 | Poland |
| Centrum Medyczne Reuma Park | Warsaw | 02 665 | Poland |
| WroMedica I Bielicka A Strzalkowska s c | Wroclaw | 51 685 | Poland |
| GCM Medical Group | San Juan | 00917 | Puerto Rico |
| Mindful Medical Research | San Juan | 00918 | Puerto Rico |
| FDI Clinical Research | San Juan | 00927 | Puerto Rico |
| Altay Medical State University | Barnaul | 656038 | Russia |
| Chelyabinck Regional Clinical Hospital | Chelyabinsk | 454076 | Russia |
| Chelyabinsk Regional Clinical Dermatovenerological Dispensary | Chelyabinsk | 454092 | Russia |
| Kemerovo State Medical University | Kemerovo | 650000 | Russia |
| LLL Medical Center Revma-Med | Kemerovo | 650070 | Russia |
| LLC Family Outpatient Clinic # 4 | Korolyov | 141060 | Russia |
| Krasnodar Clinical Dermatovenerologic Dispensary | Krasnodar | 350020 | Russia |
| Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon | Krasnoyarsk | 660123 | Russia |
| Clinical-Diagnostic Center Euromedservice, JSC | Moscow | 115419 | Russia |
| FGBU Research Institute of Rheumatology named V.A.Nasonova | Moscow | 115522 | Russia |
| GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi' | Moscow | 129110 | Russia |
| GBOU VPO Orenburg State Medical University | Orenburg | 460000 | Russia |
| Rostov Regional Clinical Dermatovenerological Dispensary | Rostov-on-Don | 344007 | Russia |
| St. Petersburg GBUZ Clinical Reumatological Hospital 25 | Saint Petersburg | 190068 | Russia |
| X7 Clinical Research Company Limited | Saint Petersburg | 194156 | Russia |
| Saratov Regional Clinical Hospital | Saratov | 410053 | Russia |
| Smolensk regional hospital on Smolensk railway station | Smolensk | 214025 | Russia |
| GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5' | Tolyatti | 445846 | Russia |
| Tula Regional Clinical Dermatovenerological Dispensary | Tula | 300053 | Russia |
| Republican Clinical Hospital - G.G. Kuvatov | Ufa | 450005 | Russia |
| Hosp. Univ. de Cruces | Barakaldo | 48903 | Spain |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp. Quiron Madrid Pozuelo | Madrid | 28223 | Spain |
| Hosp Regional Univ de Malaga | Málaga | 29011 | Spain |
| Clinica Gaias | Santiago de Compostela | 15702 | Spain |
| Hosp. Quiron Sagrado Corazon | Seville | 41013 | Spain |
| Hosp. Clinico Univ. de Valencia | Valencia | 46010 | Spain |
| Adana City Hospital | Adana | 01370 | Turkey (Türkiye) |
| Gulhane Egitim ve Arastirma Hastanesi | Ankara | 06010 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Ankara | 06800 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 6100 | Turkey (Türkiye) |
| Akdeniz Universitesi Hastanesi | Antalya | 07070 | Turkey (Türkiye) |
| Bursa Uludag Universitesi Hastanesi | Bursa | 16059 | Turkey (Türkiye) |
| Pamukkale University Medical Faculty | Denizli | 20070 | Turkey (Türkiye) |
| Osmangazi University Medical Faculty | Eskişehir | 26040 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Kartal Dr Lutfi Kirdar sehir Hastanesi | Istanbul | 34865 | Turkey (Türkiye) |
| Marmara University Medical Faculty | Istanbul | 34899 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi | Konya | 42090 | Turkey (Türkiye) |
| Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council | Cherkasy | 18009 | Ukraine |
| Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | 61204 | Ukraine |
| Khmelnitckiy regional hospital | Khmelnytsky | 29000 | Ukraine |
| City Clinical Hospital No. 2 | Kryvyi Rih | 50056 | Ukraine |
| Medical Center LLC 'Harmony of Beauty' | Kyiv | 01135 | Ukraine |
| Medical Center of 'Institute of Rheumatology', LLC | Kyiv | 02081 | Ukraine |
| Kyiv City Clinical Hospital #3 | Kyiv | 02125 | Ukraine |
| Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' | Kyiv | 03049 | Ukraine |
| SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine | Kyiv | 03151 | Ukraine |
| Medical Center 'Consylium Medical' | Kyiv | 04050 | Ukraine |
| Volyn Regional Clinical Hospital | Lutsk | 43005 | Ukraine |
| LLC Medical House | Odesa | 65026 | Ukraine |
| ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil | Poltava | 36011 | Ukraine |
| Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov | Vinnytsia | 21018 | Ukraine |
| Medical Center LLC 'Modern Clinic' | Zaporizhzhya | 69600 | Ukraine |
| Guselkumab 100 mg q8w |
Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind. |
| FG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
| Full Analysis Set | All participants who were randomized in the study. This excludes the 1 participant that was randomized and treated twice. |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to guselkumab subcutaneous (SC) injections every 4 weeks (q4w) from Week 0 through Week 20. At Week 24, participants crossed over to receive guselkumab 100 mg sc injections every 4 weeks from Week 24 through Week 100. |
| BG001 | Guselkumab 100 mg q8w | Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind. |
| BG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through to end of study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at 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. | Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | At Week 24 |
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| Secondary | Percentage of Participants Who Achieved a Psoriasis Response of Investigator's Global Assessment (IGA) Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among the Participants With >=3 Percent(%) Body Surface Area (BSA) | A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and greater than equal to (>=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). | Full analysis set included all participants who were randomized in the study and included in the analyses among the participants who had >=3% BSA psoriatic involvement and an IGA score of >=2 (mild) at baseline. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | At Week 24 |
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| Secondary | Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline. | Full analysis set included all participants who were randomized in the study and included in the analyses among the participants who had >=3% BSA psoriatic involvement and an IGA score of >=2 (mild) at baseline. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | At Week 24 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 | The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 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. | FAS included all participants who were randomized in the study and included in the analyses. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (pre dose Week 0) and Week 24 |
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| Secondary | Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. | FAS included all participants who were randomized in the study and included in the analyses. Missing data were imputed using Multiple Imputation (MI) after applying the Intercurrent Event (ICE) strategies. N (overall number of participants analyzed) included all participants with change data at Week 24 after applying the ICE Strategy and Missing Data Imputation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (pre dose Week 0) and Week 24 |
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| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. | FAS included all participants who were randomized in the study and included in the analyses. Missing data were imputed using MI after applying the ICE strategies. N (overall number of participants analyzed) included all participants with change data at Week 24 after applying the ICE Strategy and Missing Data Imputation. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline (pre dose Week 0) and Week 24 |
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| Secondary | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24 | MDA is a measure that defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1). | Full analysis set included all participants who were randomized in the study and were included in analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | At Week 24 |
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| Secondary | Percentage of Participants Who Achieved ACR 20 Response at Week 16 | 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. | Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | At Week 16 |
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| Secondary | Percentage of Participants Who Achieved ACR 50 Response at Week 16 | ACR 50 response: >=50% 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 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. | Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | At Week 16 |
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| Secondary | Percentage of Participants Who Achieved ACR 50 Response at Week 24 | ACR 50 response: >=50% 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 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. | Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | percantage of participants | At Week 24 |
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| Secondary | Percentage of Participants Who Achieved ACR 70 Response at Week 24 | ACR 70 response: >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% 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. | Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Number | percentage of participants | At Week 24 |
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| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Safety Analysis Set included all participants who received at least one (complete or partial) administration of any study intervention, i.e. the treated population. | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Emergent Related AEs (TERAEs) | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Emergent AEs Leading to Discontinuation of Study Intervention | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Infections | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Injection-site Reactions | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Infusion Related Reactions | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Post-baseline Laboratory Abnormalities With Maximum Toxicity Grade Greater Than or Equal to >=3 Based on Common Terminology Criteria for Adverse Events (CTCAE) | Not Posted | Jul 2027 | From first administration of study drug (Week 0) up to Week 112 | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Serum Guselkumab Concentration Over Time | Serum concentrations of guselkumab over time was reported. | Pharmacokinetics (PK) analysis set all participants who received at least one complete administration of guselkumab and had at least one valid blood sample drawn for PK analysis. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Mean | Standard Deviation | micrograms/milliliters (mcg/mL) | At Weeks 0, 4, 8, 12, 16, 20,and 24 |
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| Secondary | Number of Participants With Antibodies to Guselkumab | Number of participants with antibodies to guselkumab (ADA) were reported. A validated immunoassay was used to detect ADA. | Immunogenicity analysis set included all participants who received at least one (complete or partial) administration of guselkumab and who had at least 1 sample obtained after their first administration of guselkumab. | Posted | Count of Participants | Participants | Baseline (pre dose Week 0) up to Week 24 |
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From first administration of study drug (Week 0) up to Week 24
Safety analysis set included all participants who received at least one (complete or partial) administration of any study intervention, that is , the treated population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 24. Participants then received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 24 through to end of study. | 0 | 149 | 6 | 149 | 18 | 149 |
| EG001 | Guselkumab 100 mg q8w | Participants received guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks and placebo matched to guselkumab injections at other visits through to end of study. | 0 | 151 | 4 | 151 | 24 | 151 |
| EG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg subcutaneous injections every 4 weeks from Week 0 through to end of study. | 1 | 150 | 2 | 150 | 16 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Allergy to Arthropod Sting | Immune system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Myasthenia Gravis | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Abnormal Uterine Bleeding | Reproductive system and breast disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the Sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Leader PEDIATRICS IMM | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2024 | Oct 27, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: INFORMED CONSENT FORM ADDENDUM | Sep 4, 2024 | Oct 27, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: MASTER INFORMED CONSENT FORM | Jan 17, 2023 | Nov 21, 2025 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000588857 | guselkumab |
Not provided
Not provided
Not provided
| From 65 to 84 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| BULGARIA |
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| CZECH REPUBLIC |
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| HUNGARY |
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| ISRAEL |
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| MALAYSIA |
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| POLAND |
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| RUSSIAN FEDERATION |
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| SPAIN |
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| TURKEY |
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| UKRAINE |
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| UNITED STATES |
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Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind. |
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind. |
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
| OG001 | Guselkumab 100 mg q8w | Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind. |
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
| Guselkumab 100 mg q8w |
Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind. |
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
Participants received guselkumab 100 mg SC injections at Weeks 0 and 4, then every 8 weeks (q8w) from Week 12 to Week 100 and placebo matched to guselkumab SC injections at Week 8 then q8w through Week 96 to maintain the blind.
| OG002 | Guselkumab 100 mg q4w | Participants received guselkumab 100 mg SC injections q4w from Week 0 through Week 100. |
|
|
|
|