A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Ar

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease (STAR)

Last Updated August 15, 2024

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CR109043

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 4

4
Sites
226 Sites
Status

Recruiting

SUMMARY

PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.

CONDITIONS

Arthritis, Psoriatic

ELIGIBILITY

Inclusion Criteria:

* Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
* Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
* Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
* Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis

Exclusion Criteria:

* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
* Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Argentina, Australia, Bulgaria, Canada, Czechia, Denmark, Georgia, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, Thailand, Türkiye, Ukraine, United Kingdom

Country (26)	City or Province (226)	Status
United States	Chandler Arizona Arthritis & Rheumatology Research, PLLC	RECRUITING
United States	Mesa Arizona Arthritis and Rheumatology Research PLLC	RECRUITING
United States	Phoenix Arizona Arthritis Research, PLC.	RECRUITING
United States	Phoenix Arizona Arthritis and Rheumatology Research PLLC	RECRUITING
United States	Sun City Arizona Arthritis and Rheumatology Associates	RECRUITING
United States	Tucson Southern Arizona VA Healthcare System	RECRUITING
United States	Searcy Unity Health-White County Medical Center	RECRUITING
United States	Huntington Beach Newport Huntington Medical Group	RECRUITING
United States	Danbury Clinical Research Center of Connecticut	COMPLETED
United States	Bay Pines Bay Pines VA Healthcare System	RECRUITING
United States	Plantation Integral Rheumatology And Immunology Specialists	RECRUITING
United States	Zephyrhills Florida Medical Clinic, P.A.	COMPLETED
United States	Chicago Great Lakes Clinical Trials	RECRUITING
United States	Hinsdale RC Research	RECRUITING
United States	Rockford OrthoIllinois	RECRUITING
United States	Baltimore Johns Hopkins Bayview Medical	RECRUITING
United States	Hagerstown Klein And Associates M D P A	COMPLETED
United States	Saint Clair Shores Clinical Research Institute of Michigan, LLC	RECRUITING
United States	Eagan St. Paul Rhuematology P A	RECRUITING
United States	Springfield Clinvest	RECRUITING
United States	Vandalia STAT Research, Inc.	COMPLETED
United States	Portland OHSU Rheumatology Clinic, Marquam Hill	RECRUITING
United States	Amarillo Amarillo Center for Clinical Research	RECRUITING
United States	Austin Austin Regional Clinic	COMPLETED
United States	Colleyville Precision Comprehensive Clinical Research Solutions	RECRUITING
United States	Corpus Christi Adriana Pop Moody MD Clinic PA	COMPLETED
United States	Houston UT Physicians Center for Autoimmunity	RECRUITING
United States	Lubbock West Texas Clinical Research	RECRUITING
United States	Mesquite Southwest Rheumatology Research LLC	COMPLETED
United States	Red Oak Epic Medical Research	RECRUITING
United States	Tomball DM Clinical Research	RECRUITING
United States	Seattle Swedish Medical Center	RECRUITING
Argentina	Buenos Aires Cosultorios Reumatologógicos Pampa	RECRUITING
Argentina	Buenos Aires Hospital Italiano de Buenos Aires	RECRUITING
Argentina	Buenos Aires Centro Privado de Medicina Familiar	RECRUITING
Argentina	La Plata Hospital Italiano La Plata	RECRUITING
Australia	Camberwell Emeritus Research	COMPLETED
Australia	Hobart Southern Clinical Research	RECRUITING
Australia	Liverpool Liverpool Hospital	COMPLETED
Australia	Maroochydore Rheumatology Research Unit	TERMINATED
Australia	Melbourne Skin Health Institute Inc.	TERMINATED
Australia	Melbourne Eastern Health - Box Hill Hospital	COMPLETED
Bulgaria	Pleven Exacta Medica	RECRUITING
Bulgaria	Pleven UMHAT 'Dr. Georgi Stranski', EAD	RECRUITING
Bulgaria	Plovdiv Medical Center Unimed Plovdiv	RECRUITING
Bulgaria	Plovdiv UMHAT Kaspela	RECRUITING
Bulgaria	Plovdiv Medical Center Artmed	RECRUITING
Bulgaria	Sofia MHAT 'Lyulin' EAD	RECRUITING
Bulgaria	Sofia University Multiprofile Hospital Sofiamed Sofia	COMPLETED
Bulgaria	Sofia Military Medical Academy	RECRUITING
Bulgaria	Sofia UMHAT St. Ivan Rilski	RECRUITING
Bulgaria	Sofia DCC Convex EOOD	RECRUITING
Bulgaria	Sofia ASIMP Rheumatology Centre St Irina EOOD	RECRUITING
Bulgaria	Sofia Medical Centre Synexus	COMPLETED
Bulgaria	Targovishte DDC Sv. Ivan Rilski OOD	RECRUITING
Canada	Vancouver Skin Care Centre	RECRUITING
Canada	St. John's Eastern Regional Health Authority, St. Clare's Mercy Hospital	RECRUITING
Canada	Toronto Toronto Western Hospital	RECRUITING
Canada	Quebec G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.	RECRUITING
Czechia	Brno Zidenice Revmacentrum MUDr Mostera s r o	RECRUITING
Czechia	Brno Revmaclinic	COMPLETED
Czechia	Brno Revmatologie s r o	COMPLETED
Czechia	Hlucin L K N Arthrocentrum	RECRUITING
Czechia	Ostrava MUDr Rosypalova s r o	RECRUITING
Czechia	Pardubice Arthrohelp S.R.O.	RECRUITING
Czechia	Praha Revmatologicky ustav	RECRUITING
Czechia	Uherske Hradiste Medical Plus S R O	RECRUITING
Denmark	Frederiksberg Frederiksberg Hospital	RECRUITING
Denmark	Glostrup Rigshospitalet Glostrup	RECRUITING
Denmark	Køge Køge Sygehus Region Sjaelland	RECRUITING
Denmark	Vejle Vejle Sygehus	RECRUITING
Georgia	Kutaisi LTD Clinic LJ	RECRUITING
Georgia	T'bilisi Ltd American Hospital Network	RECRUITING
Georgia	T'bilisi Tbilisi Heart and Vascular Clinic Ltd	RECRUITING
Georgia	T'bilisi LTD 'Aversi Clinic'	RECRUITING
Georgia	T'bilisi Clinic on Mtskheta Street	RECRUITING
Georgia	Tbilisi Aleksandre Aladashvili Clinic LLC	RECRUITING
Georgia	Tbilisi LTD Helsicore	RECRUITING
Georgia	Tbilisi Ltd New Hospitals	RECRUITING
Georgia	Tbilisi TSMU The First University Clinic	RECRUITING
Georgia	Tbilisi LTD MediClub Georgia	RECRUITING
Georgia	Tbilisi LTD The First Medical Center	RECRUITING
Georgia	Tbilisi Consilium Medulla-multiprofile clinic Ltd	RECRUITING
Georgia	Tnilisi JSC Evex Hospitals	RECRUITING
Germany	Berlin ISA - Interdisciplinary Study Association GmbH	RECRUITING
Germany	Hamburg Hamburger Rheuma Forschungszentrum II	COMPLETED
Germany	Herne Rheumazentrum Ruhrgebiet	RECRUITING
Germany	Ratingen Rheumazentrum Ratingen	COMPLETED
Hong Kong	Hong Kong Prince Of Wales Hospital	RECRUITING
Hungary	Budapest Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz	RECRUITING
Hungary	Budapest Obudai Egeszsegugyi Centrum Kft	RECRUITING
Hungary	Budapest Qualiclinic Kft	RECRUITING
Hungary	Gyula Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz	RECRUITING
Hungary	Kistarcsa Kistarcsai Flor Ferenc Korhaz	RECRUITING
Hungary	Székesfehérvár Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz	RECRUITING
Hungary	Veszprem Vital Medical Center Orvosi es Fogaszati Kozpont	RECRUITING
Israel	Haifa Bnai Zion Medical Center	RECRUITING
Israel	Hifa Carmel Medical Center	RECRUITING
Israel	Kfar-Sava Meir Medical Center	COMPLETED
Israel	Ramat Gan Sheba Medical Center	RECRUITING
Italy	Ancona A.O. Universitaria Ospedali Riuniti di Ancona	RECRUITING
Italy	Monserrato Azienda Ospedaliero-Universitaria di Cagliari	RECRUITING
Italy	Reggio Emilia Arcispedale Santa Maria Nuova - IRCCS	RECRUITING
Italy	Roma Policlinico Tor Vergata	RECRUITING
Italy	Rozzano (MI) Humanitas Hospital	RECRUITING
Italy	Verona Azienda Ospedaliera Universitaria Integrata Verona	RECRUITING
Malaysia	Batu Caves Hospital Selayang	RECRUITING
Malaysia	George Town Hospital Pulau Pinang	RECRUITING
Malaysia	Johor Bahru Hospital Sultan Ismail	RECRUITING
Malaysia	Kuala Lumpur University Malaya Medical Centre	RECRUITING
Malaysia	Seremban Hospital Tuanku Jaafar	RECRUITING
Philippines	Cebu City Cebu Doctors' University Hospital	RECRUITING
Philippines	Davao City Davao Doctors Hospital	RECRUITING
Philippines	Lipa Lipa Medix Medical Hospital	RECRUITING
Philippines	Manila ManilaMed Medical Center Manila	RECRUITING
Philippines	Quezon City St. Luke's Medical Center	RECRUITING
Philippines	San Fernando Ilocos Training and Regional Medical Center	RECRUITING
Poland	Bialystok ClinicMed Daniluk Nowak Spolka Komandytowa	RECRUITING
Poland	Bydgoszcz Szpital Uniwersytecki nr 2 im dr Jana Biziela	RECRUITING
Poland	Bytom Nzoz Bif Med	RECRUITING
Poland	Elblag Ambulatorium sp. z o.o.	RECRUITING
Poland	Krakow Malopolskie Badania Kliniczne Sp z o o	RECRUITING
Poland	Krakow Centrum Medyczne Promed	RECRUITING
Poland	Lodz Dermed Centrum Medyczne Sp z o o	RECRUITING
Poland	Lodz Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna	RECRUITING
Poland	Lodz Centrum Medyczne AMED oddzial w Lodzi	RECRUITING
Poland	Lublin Pro Life Medica Sp. z o.o.	RECRUITING
Poland	Nadarzyn NZOZ Lecznica MAK MED S C	RECRUITING
Poland	Nowa Sol Twoja Przychodnia - Centrum Medyczne Nowa Sol	RECRUITING
Poland	Poznan Reumedika s c Wieslawa Porawska Lukasz Porawski	RECRUITING
Poland	Poznan Twoja Przychodnia Poznanskie Centrum Medyczne	RECRUITING
Poland	Swidnik Lubelskie Centrum Diagnostyczne	RECRUITING
Poland	Torun MICS Centrum Medyczne Torun	RECRUITING
Poland	Warsaw MICS Centrum Medyczne Warszawa	RECRUITING
Poland	Warsaw Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher	RECRUITING
Poland	Warszawa Centrum Medyczne Reuma Park	RECRUITING
Poland	Warszawa Rheuma-Medicus Sp. z o.o.	RECRUITING
Poland	Warszawa ETG Warszawa	COMPLETED
Poland	Warszawa Centrum Medyczne AMED Targowek	RECRUITING
Poland	Wrocław WroMedica I.Bielicka, A.Strzałkowska s.c.	RECRUITING
Portugal	Braga Ccab - Hosp. de Braga	RECRUITING
Portugal	Guarda Ulsg - Hosp. Sousa Martins	RECRUITING
Portugal	Lisboa Ipr Inst Port de Reumatologia	RECRUITING
Portugal	Lisboa Chlo - Hosp. Egas Moniz	RECRUITING
Portugal	Lisboa Hospital CUF Tejo	COMPLETED
Portugal	Lisboa Chln - Hosp. Santa Maria	RECRUITING
Portugal	Ponte de Lima Ulsam - Hosp. Conde de Bertiandos	RECRUITING
Russia	Barnaul Altay Medical State University	COMPLETED
Russia	Chelyabinsk Chelyabinck Regional Clinical Hospital	TERMINATED
Russia	Chelyabinsk Chelyabinsk Regional Clinical Dermatovenerological Dispensary	COMPLETED
Russia	Ekaterinbourg Sverdlovsk Regional Clinical Hospital N. 1	TERMINATED
Russia	Izhevsk Regional Clinical Diagnostic Center of Udmurtia Region	COMPLETED
Russia	Kemerovo LLL Medical Center Revma-Med	COMPLETED
Russia	Korolev LLC Family Outpatient Clinic # 4	COMPLETED
Russia	Krasnoyarsk Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon	TERMINATED
Russia	Moscow Clinical-Diagnostic Center Euromedservice, JSC	COMPLETED
Russia	Moscow FGBU Research Institute of Rheumatology named V.A.Nasonova	COMPLETED
Russia	Moscow GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'	COMPLETED
Russia	Omsk Llc Ultramed	COMPLETED
Russia	Orenburg GBOU VPO Orenburg State Medical University	TERMINATED
Russia	Perm GBUZ Perm Regional Clinical Hospital	TERMINATED
Russia	Petrozavodsk Republican Hospital n.a.V.A.Baranov	COMPLETED
Russia	Rostov Rostov Regional Clinical Dermatovenerological Dispensary	COMPLETED
Russia	St. Petersburg St. Petersburg GBUZ Clinical Reumatological Hospital 25	COMPLETED
Russia	St. Petersburg X7 Clinical Research Company Limited	TERMINATED
Russia	Tolyatti GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'	COMPLETED
Russia	Ufa Republican Clinical Hospital - G.G. Kuvatov	COMPLETED
Russia	Yaroslavl Clinical Hospital #3	COMPLETED
Slovakia	Martin Reumatologicka ambulancia	RECRUITING
Slovakia	Nove Mesto nad Vahom Reumatologicka ambulancia	RECRUITING
Slovakia	Piestany Reumatologická ambulancia Thermium s.r.o.	RECRUITING
Slovakia	Poprad REUMAMED POPRAD, s.r.o.	RECRUITING
Slovakia	Rimavska Sobota Reumex s.r.o	RECRUITING
Spain	A Coruna Hosp. Univ. A Coruna	RECRUITING
Spain	Barakaldo Hosp. Univ. de Cruces	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
Spain	Bilbao Hosp. Univ. de Basurto	RECRUITING
Spain	Cordoba Hosp Reina Sofia	RECRUITING
Spain	Madrid Hosp. Clinico San Carlos	COMPLETED
Spain	Málaga Hosp. Regional Univ. de Malaga	RECRUITING
Spain	Sabadell Corporacio Sanitari Parc Tauli	RECRUITING
Spain	Santiago de Compostela Clinica Gaias	RECRUITING
Spain	Sevilla Hosp. Virgen Macarena	RECRUITING
Spain	Sevilla Hosp. Quiron Sagrado Corazon	RECRUITING
Spain	Valencia Hosp. Univ. I Politecni La Fe	RECRUITING
Sweden	Solna Karolinska Universitetssjukhuset	RECRUITING
Sweden	Uppsala Akademiska Sjukhuset	RECRUITING
Taiwan	Hsin Chu National Taiwan University Hospital	RECRUITING
Taiwan	Tainan National Cheng Kung University Hospital	RECRUITING
Taiwan	Taoyuan Linkou Chang Gung Memorial Hospital	RECRUITING
Thailand	Bangkok Phramongkutklao Hospital and Medical College	RECRUITING
Thailand	Bangkok Ramathibodi Hospital Mahidol University	RECRUITING
Thailand	Chiangmai Chiang Mai University	RECRUITING
Türkiye	Adana Adana City Hospital	RECRUITING
Türkiye	Ankara Gulhane Training and Research Hospital	RECRUITING
Türkiye	Ankara Ankara Bilkent City Hospital	COMPLETED
Türkiye	Ankara Hacettepe University Medical Faculty	COMPLETED
Türkiye	Antalya Akdeniz University Medical Faculty	RECRUITING
Türkiye	Bursa Uludag University Medical Faculty	RECRUITING
Türkiye	Istanbul Istanbul University Cerrahpasa Medical Faculty	RECRUITING
Türkiye	Istanbul Marmara University Medical Faculty	RECRUITING
Türkiye	Konya Necmettin Erbakan University Meram Medical Faculty	RECRUITING
Ukraine	Cherkasy Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council	TERMINATED
Ukraine	Kharkiv Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital	COMPLETED
Ukraine	Khmelnytsky Khmelnitckiy regional hospital	TERMINATED
Ukraine	Kryvyi Rih City Clinical Hospital No. 2	TERMINATED
Ukraine	Kyiv Medical Center of 'Institute of Rheumatology', LLC	TERMINATED
Ukraine	Kyiv Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'	COMPLETED
Ukraine	Kyiv SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine	COMPLETED
Ukraine	Lutsk Volyn Regional Clinical Hospital	COMPLETED
Ukraine	Odessa Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council	TERMINATED
Ukraine	Poltava ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil	TERMINATED
Ukraine	Ternopil Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'	COMPLETED
Ukraine	Vinnytsia Health Clinic Limited Liability Company	TERMINATED
Ukraine	Zaporizhzhya Medical Center LLC 'Modern Clinic'	TERMINATED
United Kingdom	Barnet Royal Free London NHS Foundation Trust	RECRUITING
United Kingdom	Bradford St. Lukes Hospital	RECRUITING
United Kingdom	Coventry University Hospital Coventry & Warwickshire NHS Trust	RECRUITING
United Kingdom	Leeds Chapel Allerton Hospital	RECRUITING
United Kingdom	Manchester Central Manchester University Hospitals NHS Foundation Trust	RECRUITING
United Kingdom	Newcastle North Tyneside General Hospital	RECRUITING
United Kingdom	Stoke on Trent Haywood Hospital	RECRUITING
Argentina	San Fernando Buenos Aires MR Medicina Reumatologica	RECRUITING
Poland	Elblag Centrum Kliniczno Badawcze	COMPLETED
Poland	Lublin Velocity Lublin	RECRUITING
Portugal	Porto Chsj - Hosp. Sao Joao	RECRUITING

Geo Locations

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OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

33.30616, -111.84125

33.42227, -111.82264

33.44838, -112.07404

33.44838, -112.07404

33.59754, -112.27182

32.22174, -110.92648

35.25064, -91.73625

33.6603, -117.99923

41.39482, -73.45401

27.81419, -82.77816

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28.23362, -82.18119

41.85003, -87.65005

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42.27113, -89.094

39.29038, -76.61219

39.64176, -77.71999

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44.80413, -93.16689

37.21533, -93.29824

39.89061, -84.19883

45.52345, -122.67621

35.222, -101.8313

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47.60621, -122.33207

-34.61315, -58.37723

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-34.92145, -57.95453

-37.84205, 145.0694

-42.87936, 147.32941

-33.90011, 150.93328

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-37.814, 144.96332

43.41667, 24.61667

43.41667, 24.61667

42.15, 24.75

42.15, 24.75

42.15, 24.75

42.69751, 23.32415

42.69751, 23.32415

42.69751, 23.32415

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42.69751, 23.32415

43.2512, 26.57215

49.24966, -123.11934

47.56494, -52.70931

43.70011, -79.4163

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49.2043901, 16.6408423

49.19522, 16.60796

49.19522, 16.60796

49.89795, 18.19196

49.83465, 18.28204

50.04075, 15.77659

50.08804, 14.42076

49.06975, 17.45969

55.67938, 12.53463

55.6666, 12.40377