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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505477-33 | Other Identifier | EU CT |
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The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. Period 2 is the long-term period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. Participants remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Experimental | Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316. |
|
| Placebo | Placebo Comparator | Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Placebo for risankizumab administered by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group /ID# 167953 | Anniston | Alabama | 36207 | United States | ||
| St. Jude Heritage /ID# 166842 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34815219 | Result | Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Alperovich G, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022 Mar;81(3):351-358. doi: 10.1136/annrheumdis-2021-221048. Epub 2021 Nov 23. | |
| 41318485 |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Participants were randomized equally (1:1 ratio) to receive double-blind treatment with risankizumab 150 mg or matched placebo for 24 weeks. Randomization was stratified by current conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) use (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% body surface area [BSA] or < 3% BSA) at Baseline.
Participants were enrolled at 99 sites in Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, New Zealand, Poland, Portugal, South Africa, Spain, Sweden, United Kingdom, and the US including Puerto Rico.
The study includes a 24-week double-blind placebo-controlled treatment period (Period 1) and an ongoing 184-week open-label treatment period (Period 2). Results are reported for Period 1 which was from 07 March 2019 to 22 June 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants randomized to receive placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. |
| FG001 | Risankizumab | Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. |
| 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 10, 2020 | Feb 1, 2022 |
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| Risankizumab | Biological | Risankizumab administered by subcutaneous (SC) injection |
|
|
| Baseline and Week 24 |
| Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score. | Baseline and Week 24 |
| Percentage of Participants With an ACR20 Response at Week 16 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Baseline and Week 16 |
| Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | A participant was classified as achieving MDA if 5 of the following 7 criteria were met:
| Week 24 |
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement. | Baseline and Week 24 |
| Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement. | Baseline and Week 24 |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Baseline and Week 24 |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
| Baseline and Week 24 |
| Percentage of Participants With Resolution of Enthesitis at Week 24 | Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0. LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst). | Week 24 |
| Percentage of Participants With Resolution of Dactylitis at Week 24 | Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0. The LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used. Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. | Week 24 |
| Fullerton |
| California |
| 92835 |
| United States |
| Newport Huntington Medica /ID# 207423 | Huntington Beach | California | 92648-5994 | United States |
| Arthritis & Osteo Medical Ctr /ID# 166541 | La Palma | California | 90623-1728 | United States |
| East Bay Rheumatology Medical /ID# 166845 | San Leandro | California | 94578 | United States |
| Inland Rheum Clin Trials Inc. /ID# 166621 | Upland | California | 91786 | United States |
| Denver Arthritis Clinic /ID# 166442 | Denver | Colorado | 80230 | United States |
| New England Research Associates, LLC /ID# 166525 | Bridgeport | Connecticut | 06606-1827 | United States |
| Yale University /ID# 166330 | New Haven | Connecticut | 06510 | United States |
| Arthritis & Rheumatic Disease Specialties /ID# 212582 | Aventura | Florida | 33180 | United States |
| SIMED Health, LLC /ID# 207457 | Gainesville | Florida | 32607-2817 | United States |
| Sweet Hope Research Specialty Inc /ID# 168163 | Hialeah | Florida | 33016-1897 | United States |
| Rheum Assoc of Central FL /ID# 201629 | Orlando | Florida | 32806 | United States |
| HMD Research LLC /ID# 208428 | Orlando | Florida | 32819 | United States |
| Millennium Research /ID# 201627 | Ormond Beach | Florida | 32174 | United States |
| Arthritis Center, Inc. /ID# 208116 | Palm Harbor | Florida | 34684 | United States |
| IRIS Research and Development, LLC /ID# 166351 | Plantation | Florida | 33324 | United States |
| BayCare Medical Group /ID# 201630 | St. Petersburg | Florida | 33705 | United States |
| West Broward Rheumatology Associates /ID# 201234 | Tamarac | Florida | 33321 | United States |
| University of South Florida /ID# 208467 | Tampa | Florida | 33612 | United States |
| ForCare Clinical Research /ID# 166375 | Tampa | Florida | 33613-1244 | United States |
| Arthritis and Rheumatology /ID# 169438 | Atlanta | Georgia | 30342 | United States |
| Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681 | Skokie | Illinois | 60076 | United States |
| Springfield Clinic /ID# 166345 | Springfield | Illinois | 62702-3749 | United States |
| Ochsner Clinic Foundation /ID# 166622 | Baton Rouge | Louisiana | 70836-6455 | United States |
| The Arthritis & Diabetes Clinic, Inc. /ID# 166707 | Monroe | Louisiana | 71203 | United States |
| MMP Women's Health /ID# 169334 | Portland | Maine | 04102 | United States |
| Klein and Associates MD /ID# 166549 | Hagerstown | Maryland | 21740 | United States |
| Duplicate_The Center for Rheumatology & Bone Research /ID# 166448 | Wheaton | Maryland | 20902 | United States |
| Clinical Pharmacology Study Gr /ID# 166455 | Worcester | Massachusetts | 01605 | United States |
| St. Paul Rheumatology /ID# 166599 | Eagan | Minnesota | 55121 | United States |
| Clinvest Research LLC /ID# 166745 | Springfield | Missouri | 65810-2607 | United States |
| Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389 | St Louis | Missouri | 63119-3845 | United States |
| Glacier View Research Institute /ID# 169344 | Kalispell | Montana | 59901 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 169443 | Lebanon | New Hampshire | 03756 | United States |
| Ocean Rheumatology, PA /ID# 166561 | Toms River | New Jersey | 08755 | United States |
| Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658 | Voorhees Township | New Jersey | 08043 | United States |
| Paramount Medical Research Con /ID# 166334 | Middleburg Heights | Ohio | 44130 | United States |
| Health Research of Oklahoma /ID# 166408 | Oklahoma City | Oklahoma | 73103-2400 | United States |
| Altoona Ctr Clinical Res /ID# 166691 | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Research Ctr Reading /ID# 166354 | Wyomissing | Pennsylvania | 19610 | United States |
| West Tennessee Research Institute /ID# 166429 | Jackson | Tennessee | 38305 | United States |
| Nashville Arthritis and Rheumatology /ID# 208395 | Nashville | Tennessee | 37203 | United States |
| Amarillo Ctr for Clin Research /ID# 208340 | Amarillo | Texas | 79124 | United States |
| Tekton Research, Inc. /ID# 166493 | Austin | Texas | 78745 | United States |
| Precision Comprehensive Clinical Research Solutions /ID# 208156 | Colleyville | Texas | 76034 | United States |
| Rheumatology Clinic of Houston /ID# 166636 | Houston | Texas | 77065 | United States |
| West Texas Clinical Research /ID# 208155 | Lubbock | Texas | 79410-1198 | United States |
| SW Rheumatology Res. LLC /ID# 166587 | Mesquite | Texas | 75150 | United States |
| Trinity Universal Research Associates, Inc /ID# 208387 | Plano | Texas | 75024-5283 | United States |
| DM Clinical Research /ID# 208350 | Tomball | Texas | 77375 | United States |
| Kadlec Clinic Rheumatology /ID# 167667 | Kennewick | Washington | 99336 | United States |
| Arthritis Northwest, PLLC /ID# 169535 | Spokane | Washington | 99204-2302 | United States |
| Rheumatology and Pulmonary Clinic /ID# 169341 | Beckley | West Virginia | 25801 | United States |
| Rheumatic Disease Center, LLP /ID# 166682 | Glendale | Wisconsin | 53217 | United States |
| Hospital General de Agudos J. M. Ramos Mejia /ID# 169152 | Buenos Aires | Ciuadad Autonoma de Buenos Aires | 1221 | Argentina |
| Hospital Italiano de Buenos Aires /ID# 208473 | Ciudad Autonoma Buenos Aires | Ciuadad Autonoma de Buenos Aires | 1199 | Argentina |
| DOM Centro de Reumatologia /ID# 208478 | Ciudad Autonoma de Buenos Aire | Ciuadad Autonoma de Buenos Aires | 1111 | Argentina |
| Centro de Enfermedades del HÃgado y Aparato Digestivo /ID# 169151 | Rosario | Santa Fe Province | 2000 | Argentina |
| Instituto CAICI /ID# 169156 | Rosario | Santa Fe Province | 2000 | Argentina |
| Centro Medico Privado de Reumatologia /ID# 208342 | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Cimer /Id# 169155 | San Miguel de Tucumán | 4000 | Argentina |
| The Canberra Hospital /ID# 207591 | Garran | Australian Capital Territory | 2605 | Australia |
| Rheumatology Research Unit Sunshine Coast /ID# 207191 | Maroochydore | Queensland | 4558 | Australia |
| Griffith University /ID# 207504 | Southport | Queensland | 4222 | Australia |
| Emeritus Research /ID# 207195 | Camberwell | Victoria | 3124 | Australia |
| Monash Medical Centre /ID# 208033 | Clayton | Victoria | 3168 | Australia |
| UZ Gent /ID# 210037 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 208209 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| ReumaClinic /ID# 208211 | Genk | 3600 | Belgium |
| ZNA - Jan Palfijn /ID# 208210 | Merksem | 2170 | Belgium |
| CIP - Centro Internacional de Pesquisa /ID# 169524 | Goiânia | Goiás | 74110-120 | Brazil |
| LMK Sevicos Medicos S/S /ID# 169541 | Porto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
| Percuro Clinical Research, Ltd /ID# 169530 | Victoria | British Columbia | V8V 3M9 | Canada |
| CIADS Research Co Ltd /ID# 169526 | Winnipeg | Manitoba | R3N 0K6 | Canada |
| Dermatrials Research /ID# 208303 | Hamilton | Ontario | L8N 1Y2 | Canada |
| K. Papp Clinical Research /ID# 169527 | Waterloo | Ontario | N2J 1C4 | Canada |
| Centre Rhumatologie de l'Est /ID# 208302 | Rimouski | Quebec | G5L 8W1 | Canada |
| Bispebjerg and Frederiksberg Hospital /ID# 168763 | Frederiksberg | Capital Region | 2000 | Denmark |
| Aarhus University Hospital /ID# 168762 | Aarhus C | Central Jutland | 8000 | Denmark |
| East Tallinn Central Hospital /ID# 208317 | Tallinn | Harju | 10138 | Estonia |
| MediTrials /ID# 207815 | Tartu | Tartu | 50708 | Estonia |
| North Estonia Medical Centre /ID# 208319 | Tallinn | 13419 | Estonia |
| Ite Pihlajanlinna Kuopio /ID# 208316 | Kuopio | 70100 | Finland |
| Turku University Hospital /ID# 208199 | Turku | 20520 | Finland |
| Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159 | Bordeaux | 33076 | France |
| CHRU Tours - Hopital Trousseau /ID# 209343 | Chambray-lès-Tours | 37170 | France |
| Rheumazentrum Ruhrgebiet /ID# 207212 | Herne | North Rhine-Westphalia | 44649 | Germany |
| Immanuel Krankenhaus Berlin /ID# 207214 | Buch | 13125 | Germany |
| Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494 | Frankfurt | 60590 | Germany |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493 | Hamburg | 20095 | Germany |
| University General Hospital of Heraklion PA.G.N.I /ID# 206930 | Heraklion | Crete | 71307 | Greece |
| Naval Hospital of Athens /ID# 206928 | Athens | 11521 | Greece |
| Olympion General Clinic SA /ID# 207047 | Pátrai | 26443 | Greece |
| CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248 | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237 | Szeged | Csongrád megye | 6725 | Hungary |
| Vital-Medicina Kft. /ID# 208123 | Veszprém | Veszprém megye | 8200 | Hungary |
| Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054 | Budapest | 1023 | Hungary |
| Sheba Medical Center /ID# 207468 | Ramat Gan | Tel Aviv | 5239424 | Israel |
| Barzilai Medical Center /ID# 207471 | Ashkelon | 7830604 | Israel |
| Rambam Health Care Campus /ID# 208169 | Haifa | 3109601 | Israel |
| Meir Medical Center /ID# 207469 | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center /ID# 207470 | Petah Tikva | 4941492 | Israel |
| Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800 | Modena | Emilia-Romagna | 41124 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268 | Ancona | 60126 | Italy |
| Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264 | Verona | 37134 | Italy |
| Antonius Ziekenhuis /ID# 208581 | Sneek | Provincie Friesland | 8601 ZK | Netherlands |
| Universitair Medisch Centrum Groningen /ID# 168450 | Groningen | 9713 GZ | Netherlands |
| Medisch Centrum Leeuwarden /ID# 168449 | Leeuwarden | 8934 AD | Netherlands |
| Waikato Hospital /ID# 214276 | Hamilton | Waikato Region | 3204 | New Zealand |
| Middlemore Clinical Trials /ID# 214293 | Auckland | 2025 | New Zealand |
| CGM Research Trust /ID# 210596 | Burwood Christchurch | 8083 | New Zealand |
| Malopolskie Centrum Kliniczne /ID# 208011 | Krakow | Lesser Poland Voivodeship | 30-149 | Poland |
| Centrum Medyczne Reuma Park w Warszawie /ID# 210956 | Warsaw | Masovian Voivodeship | 02-691 | Poland |
| Osteo-Medic S.C. /ID# 208013 | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012 | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Centrum Kliniczno-Badawcze /ID# 208014 | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138 | Ponte de Lima | Viana do Castelo District | 4990-041 | Portugal |
| Instituto Português De Reumatologia /ID# 208140 | Lisbon | 1050-034 | Portugal |
| Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139 | Lisbon | 1649-035 | Portugal |
| GCM Medical Group PSC - Hato Rey /ID# 208461 | San Juan | 00917-3104 | Puerto Rico |
| Changi General Hospital /ID# 208966 | Singapore | 529889 | Singapore |
| Dr Jenny Potts /ID# 167628 | Port Elizabeth | Eastern Cape | 6405 | South Africa |
| Arthritis Clinical Research Trials /ID# 167611 | Cape Town | Western Cape | 7405 | South Africa |
| Winelands Medical Research Centre /ID# 167630 | Stellenbosch | Western Cape | 7600 | South Africa |
| Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822 | Sabadell | Barcelona | 08208 | Spain |
| Hospital Unversitario Marques de Valdecilla /ID# 208541 | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario A Coruna - CHUAC /ID# 207819 | A Coruña | 15006 | Spain |
| Hospital Universitario 12 de Octubre /ID# 207820 | Madrid | 28041 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 207823 | Valencia | 46026 | Spain |
| Duplicate_Karolinska Univ Sjukhuset /ID# 208174 | Solna | 171 64 | Sweden |
| Uppsala University Hospital /ID# 169098 | Uppsala | 75185 | Sweden |
| Duplicate_Vastmanlands Sjukhus /ID# 168620 | Västerås | 723 35 | Sweden |
| Orebro Universitetssjukhuset /ID# 169400 | Örebro | Örebro County | 701 85 | Sweden |
| Duplicate_Barts Health NHS Trust /ID# 210794 | London | London, City of | E11 1NR | United Kingdom |
| Manchester University NHS Foundation Trust /ID# 207923 | Manchester | M13 9WL | United Kingdom |
| Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536 | Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| Torbay and South Devon Nhs Foundation Trust /Id# 207926 | Torquay | TQ2 7AA | United Kingdom |
| Derived |
| Gossec L, Balanescu A, D'Agostino MA, Ogdie A, Sewerin P, Deng Y, Shi L, Sugimoto Y, Zhong S, Xing Y, Lippe R, Kishimoto M. Efficacy of Risankizumab across distinct PsA phenotypes identified with machine learning analytics using data from biologic DMARD-Naive patients in two phase 3 clinical trials. Arthritis Res Ther. 2025 Nov 29;28(1):2. doi: 10.1186/s13075-025-03670-0. |
| 41028616 | Derived | Ostor A, Van den Bosch F, Papp K, Keiserman M, Blanco R, Crowley A, White D, Biljan A, Madihlaba T, Carter K, Liu F, Soliman AM, Ashley D, Chen M, Glotfelty L, Kivitz A. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials. Rheumatol Ther. 2025 Dec;12(6):1103-1123. doi: 10.1007/s40744-025-00793-3. Epub 2025 Sep 30. |
| 39120849 | Derived | Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9. |
| 38739215 | Derived | Kwatra SG, Khattri S, Amin AZ, Ranza R, Kaplan B, Shi L, Padilla B, Soliman AM, McGonagle D. Enthesitis and Dactylitis Resolution with Risankizumab for Active Psoriatic Arthritis: Integrated Analysis of the Randomized KEEPsAKE 1 and 2 Trials. Dermatol Ther (Heidelb). 2024 Jun;14(6):1517-1530. doi: 10.1007/s13555-024-01174-4. Epub 2024 May 13. |
| 38498139 | Derived | Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Carter K, Stakias V, Lippe R, Drogaris L, Soliman AM, Chen MM, Padilla B, Kivitz A. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial. Rheumatol Ther. 2024 Jun;11(3):633-648. doi: 10.1007/s40744-024-00657-2. Epub 2024 Mar 18. |
| 36282537 | Derived | Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Lu W, Wang Z, Soliman AM, Eldred A, Padilla B, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2122-2129. doi: 10.1093/rheumatology/keac605. |
| 36178584 | Derived | Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30. |
| 35701011 | Derived | Ostor AJK, Soliman AM, Papp KA, Padilla B, Wang Z, Eldred A, de Vlam K, Kivitz A. Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. RMD Open. 2022 Jun;8(2):e002286. doi: 10.1136/rmdopen-2022-002286. |
| Received Study Drug |
|
| COMPLETED | Completed Period 1 Study Participation |
|
| NOT COMPLETED |
|
|
The full analysis set included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. |
| BG001 | Risankizumab | Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. |
| BG002 | 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/Ethnicity, Customized | Count of Participants | Participants |
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| Current Use of Conventional Synthetic Disease-modifying Anti-rheumatic Drug (csDMARD) | Count of Participants | Participants |
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| Number of Prior Biologic Therapies | Count of Participants | Participants |
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| Extent of Psoriasis | The extent of psoriasis was measured by the physician as the total body surface area (BSA) involved with psoriasis. For purposes of clinical estimation, the total surface of the participant's palm and five digits was assumed to be approximately equivalent to 1% of BSA. | Count of Participants | Participants |
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| Tender Joint Count | A total of 68 joints were assessed for the presence or absence of tenderness by pressure manipulation on physical examination. | Mean | Standard Deviation | joints |
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| Swollen Joint Count | A total of 66 joints were assessed for the presence or absence of swelling by directed physical examination. | Mean | Standard Deviation | joints |
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| Patient's Assessment of Pain | Participants were asked to indicate the severity of their arthritis pain within the previous 24 hours using a horizontal 100 mm visual analog scale (VAS), ranging from 0 (no pain) to 100 (severe pain). | Mean | Standard Deviation | score on a scale |
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| Patient's Global Assessment of Disease Activity | Participants were asked to rate their current psoriatic arthritis disease activity within the past 24 hours on a horizontal 100 mm VAS ranging from 0 (very well) to 100 (very poor). | Mean | Standard Deviation | score on a scale |
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| Physician's Global Assessment of Disease Activity | The physician rated the participant's current global psoriatic arthritis disease activity in the past 24 hours (independently from the participant's assessment) on a 100 mm horizontal VAS ranging from 0 (very well) to 100 (very poorly). | participants with available data | Mean | Standard Deviation | score on a scale |
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| Health Assessment Questionnaire - Disability Index (HAQ-DI) | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. | Mean | Standard Deviation | score on a scale |
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| High-sensitivity C-reactive Protein (hsCRP) | Mean | Standard Deviation | mg/L |
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| Psoriasis Area Severity Index (PASI) Score | PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration, and desquamation of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Participants with psoriasis BSA involvement ≥ 3% at Baseline | Mean | Standard Deviation | score on a scale |
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| Short-Form 36 (SF-36) Physical Component Summary (PCS) Score | The SF-36 Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS ranges from 0 to 100, with a normative mean value of 50; higher scores are associated with less disability. | Mean | Standard Deviation | score on a scale |
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| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue, functional fatigue, emotional fatigue, and social consequences of fatigue. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. | Mean | Standard Deviation | score on a scale |
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| Presence of Enthesitis | Enthesitis is inflammation of the entheses, the specific point where tendons or ligaments attach to bone. The Leeds enthesitis index (LEI) is a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus left and right, Achilles tendon insertion left and right and medial condyle femur left and right. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 6 sites, for an overall score range of 0 to 6. Presence of enthesitis is defined as an LEI > 0. | Count of Participants | Participants |
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| Presence of Dactylitis | Dactylitis is characterized by swelling of the fingers or toes. The Leeds dactylitis index (LDI) basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). Scores for each digit are summed for the total LDI. The presence of dactylitis is defined as LDI > 0. | 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 With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Full analysis set; Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
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| Secondary | Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 | The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement. | Full analysis set; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis (PsA) use that could meaningfully impact efficacy assessment, was used. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Week 24 |
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| Secondary | Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24 | PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score. | Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
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| Secondary | Percentage of Participants With an ACR20 Response at Week 16 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 16 |
|
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| Secondary | Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 | A participant was classified as achieving MDA if 5 of the following 7 criteria were met:
| Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 | The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement. | Full analysis set; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Week 24 |
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| Secondary | Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement. | Full analysis set; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 24, excluding data after initiation of rescue medication or initiation of concomitant medications for psoriatic arthritis use that could meaningfully impact efficacy assessment, was used. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Week 24 |
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| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
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| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
| Full analysis set; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
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| Secondary | Percentage of Participants With Resolution of Enthesitis at Week 24 | Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0. LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst). | Full analysis set participants with a Baseline LEI > 0; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Resolution of Dactylitis at Week 24 | Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0. The LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used. Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. | Full analysis set participants with a Baseline LDI > 0; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
|
From first dose of study drug to Week 24
Not provided
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 administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. | 0 | 219 | 12 | 219 | 11 | 219 |
| EG001 | Risankizumab 150 mg | Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. | 0 | 224 | 9 | 224 | 17 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| ABSCESS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| POSTOPERATIVE ABSCESS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| MYELOPATHY | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| METRORRHAGIA | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2020 | Feb 1, 2022 | SAP_001.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 |
|---|---|
| C000601773 | risankizumab |
Not provided
Not provided
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Response Rate Difference = Risankizumab - Placebo |
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Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. |
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Participants received 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1.
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