Phase
Condition
Rheumatoid Arthritis
Treatment
Tulisokibart
Methotrexate
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)classification criteria
Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollenjoints (based on 66 joints)
Has current treatment with oral or parenteral methotrexate (MTX) therapy
Has history of one of the following: a) biologic disease-modifying antirheumaticdrug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to amaximum of 2 classes of bDMARDS
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has any arthritis with onset before age 17 years or current diagnosis ofinflammatory joint disease other than RA (such as, but not limited to, psoriaticarthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis,pseudogout, etc) or any other condition that may, in the judgment of theinvestigator, interfere with the assessment of RA
Has a history of cancer (except fully treated nonmelanoma skin cancers or cervicalcarcinoma in situ after complete surgical removal) and is disease free for <5 yearsbefore randomization
Has any active infection
Has known allergies, hypersensitivity, or intolerance to tulisokibart or itsexcipients
Study Design
Study Description
Connect with a study center
Mount Sinai Hospital ( Site 1102)
Toronto, Ontario M5T 3L9
CanadaActive - Recruiting
CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)
Sherbrooke, Quebec J1G 2E8
CanadaActive - Recruiting
Centre de Recherche Musculo-Squelettique ( Site 1101)
Trois-Rivières, Quebec G9A 3X2
CanadaActive - Recruiting
CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)
Sherbrooke 6146143, Quebec 6115047 J1G 2E8
CanadaSite Not Available
Centre de Recherche Musculo-Squelettique ( Site 1101)
Trois-Rivières 6169141, Quebec 6115047 G9A 3X2
CanadaSite Not Available
CECIM ( Site 1208)
Santiago, Region M. de Santiago 8320000
ChileActive - Recruiting
Centro de Estudios GyC ( Site 1206)
Santiago, Region M. de Santiago 7500504
ChileActive - Recruiting
Clinica Dermacross ( Site 1203)
Santiago, Region M. de Santiago 7640881
ChileActive - Recruiting
Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)
Santiago, Region M. de Santiago 8330073
ChileActive - Recruiting
CECIM ( Site 1208)
Santiago 3871336, Region M. de Santiago 8320000
ChileActive - Recruiting
Centro de Estudios GyC ( Site 1206)
Santiago 3871336, Region M. de Santiago 7500504
ChileActive - Recruiting
Clinica Dermacross ( Site 1203)
Santiago 3871336, Region M. de Santiago 7640881
ChileActive - Recruiting
Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)
Santiago 3871336, Region M. de Santiago 8330073
ChileSite Not Available
Peking University First Hospital ( Site 2511)
Beijing, Beijing Municipality 100034
ChinaActive - Recruiting
Peking University First Hospital ( Site 2511)
Beijing 1816670, Beijing Municipality 2038349 100034
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University. ( Site 2510)
Xiamen, Fujian 361003
ChinaActive - Recruiting
The First Affiliated Hospital of Xiamen University. ( Site 2510)
Xiamen 1790645, Fujian 1811017 361003
ChinaSite Not Available
The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)
Guangzhou, Guangdong 510630
ChinaActive - Recruiting
The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)
Guangzhou 1809858, Guangdong 1809935 510630
ChinaSite Not Available
Xinxiang Central Hospital ( Site 2501)
Xinxiang, Henan 453000
ChinaActive - Recruiting
Xinxiang Central Hospital ( Site 2501)
Xinxiang 1788572, Henan 1808520 453000
ChinaSite Not Available
Pingxiang People's Hospital ( Site 2512)
Pingxiang, Jiangxi 337000
ChinaActive - Recruiting
Pingxiang People's Hospital ( Site 2512)
Pingxiang 1798654, Jiangxi 1806222 337000
ChinaSite Not Available
Linfen Central Hospital ( Site 2507)
Linfen, Shanxi 041000
ChinaActive - Recruiting
Linfen Central Hospital ( Site 2507)
Linfen 1803567, Shanxi 1795912 041000
ChinaSite Not Available
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)
Ürümqi, Xinjiang 830001
ChinaActive - Recruiting
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)
Ürümqi 1529102, Xinjiang 1529047 830001
ChinaSite Not Available
Taizhou Hospital of Zhejiang Province ( Site 2506)
Linhai, Zhejiang 317000
ChinaActive - Recruiting
Taizhou Hospital of Zhejiang Province ( Site 2506)
Linhai 1803422, Zhejiang 1784764 317000
ChinaSite Not Available
Clinica de la Costa S.A.S. ( Site 1301)
Barranquilla, Atlántico 080020
ColombiaActive - Recruiting
Clinica de la Costa S.A.S. ( Site 1301)
Barranquilla 3689147, Atlántico 3689436 080020
ColombiaSite Not Available
CIREEM SAS ( Site 1304)
Bogota, Cundinamarca 110111
ColombiaActive - Recruiting
Fundación Valle del Lili ( Site 1305)
Cali, Valle del Cauca Department 760032
ColombiaActive - Recruiting
Fundación Valle del Lili ( Site 1305)
Cali 3687925, Valle del Cauca Department 3666313 760032
ColombiaSite Not Available
Medicover München Ost MVZ ( Site 1607)
München, Bavaria 81667
GermanyActive - Recruiting
Medicover München Ost MVZ ( Site 1607)
München 2867713, Bavaria 2951839 81667
GermanySite Not Available
Rheuma-Research Lausitz ( Site 1604)
Cottbus, Brandenburg 03042
GermanyActive - Recruiting
Rheuma-Research Lausitz ( Site 1604)
Cottbus 2939811, Brandenburg 2945356 03042
GermanySite Not Available
Rheumazentrum Ratingen Studienambulanz ( Site 1601)
Ratingen, North Rhine-Westphalia 40878
GermanyActive - Recruiting
Rheumazentrum Ratingen Studienambulanz ( Site 1601)
Ratingen 2850174, North Rhine-Westphalia 2861876 40878
GermanySite Not Available
Rheumatologische Schwerpunktpraxis ( Site 1603)
Berlin, 12161
GermanyActive - Recruiting
Rheumatologische Schwerpunktpraxis ( Site 1603)
Berlin 2950159, 12161
GermanySite Not Available
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)
Hamburg, 20095
GermanyActive - Recruiting
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)
Hamburg 2911298, 20095
GermanySite Not Available
Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)
Hanishina-gun, Nagano 389-0606
JapanActive - Recruiting
Sasebo Chuo Hospital ( Site 2602)
Sasebo, Nagasaki 857-1195
JapanActive - Recruiting
Sasebo Chuo Hospital ( Site 2602)
Sasebo 1852899, Nagasaki 1856156 857-1195
JapanSite Not Available
Nagaoka Red Cross Hospital ( Site 2604)
Nagaoka, Niigata 940-2085
JapanActive - Recruiting
Nagaoka Red Cross Hospital ( Site 2604)
Nagaoka 1856199, Niigata 1855429 940-2085
JapanSite Not Available
Hirose Clinic ( Site 2601)
Tokorozawa, Saitama 359-1111
JapanActive - Recruiting
Hirose Clinic ( Site 2601)
Tokorozawa 1850181, Saitama 1853226 359-1111
JapanSite Not Available
University of Yamanashi Hospital ( Site 2603)
Chūō, Yamanashi 409-3898
JapanActive - Recruiting
University of Yamanashi Hospital ( Site 2603)
Chūō 11612585, Yamanashi 1848649 409-3898
JapanSite Not Available
Kai Clinic ( Site 2600)
Miyazaki, 880-0053
JapanActive - Recruiting
Kai Clinic ( Site 2600)
Miyazaki 1856717, 880-0053
JapanSite Not Available
MICS Centrum Medyczne Bydgoszcz ( Site 1807)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-065
PolandActive - Recruiting
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168
PolandActive - Recruiting
MICS Centrum Medyczne Torun ( Site 1803)
Torun, Kuyavian-Pomeranian Voivodeship 87-100
PolandActive - Recruiting
MICS Centrum Medyczne Bydgoszcz ( Site 1807)
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-065
PolandActive - Recruiting
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-168
PolandSite Not Available
MICS Centrum Medyczne Torun ( Site 1803)
Torun 3083271, Kuyavian-Pomeranian Voivodeship 3337500 87-100
PolandSite Not Available
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)
Lublin, Lublin Voivodeship 20-607
PolandActive - Recruiting
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)
Lublin 765876, Lublin Voivodeship 858785 20-607
PolandSite Not Available
MICS Centrum Medyczne Warszawa ( Site 1805)
Warsaw, Masovian Voivodeship 00-874
PolandActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)
Warsaw, Masovian Voivodeship 02-637
PolandActive - Recruiting
MICS Centrum Medyczne Warszawa ( Site 1805)
Warsaw 756135, Masovian Voivodeship 858787 00-874
PolandSite Not Available
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)
Warsaw 756135, Masovian Voivodeship 858787 02-637
PolandActive - Recruiting
NZOZ BIF-MED ( Site 1802)
Bytom, Silesian Voivodeship 41-902
PolandActive - Recruiting
NZOZ BIF-MED ( Site 1802)
Bytom 3101950, Silesian Voivodeship 3337497 41-902
PolandSite Not Available
Soon Chun Hyang University Cheonan Hospital ( Site 2304)
Cheonan-si, Chungcheongnam-do 31151
South KoreaActive - Recruiting
Chungnam national university hospital ( Site 2303)
Daejeon, Taejon-Kwangyokshi 35015
South KoreaActive - Recruiting
Chungnam national university hospital ( Site 2303)
Daejeon 1835235, Taejon-Kwangyokshi 35015
South KoreaSite Not Available
Hanyang University Seoul Hospital ( Site 2300)
Seoul, 04763
South KoreaActive - Recruiting
Hanyang University Seoul Hospital ( Site 2300)
Seoul 1835848, 04763
South KoreaSite Not Available
Hospital Universitari Parc Tauli ( Site 1900)
Sabadell, Barcelona 8208
SpainActive - Recruiting
Hospital Universitari Parc Tauli ( Site 1900)
Sabadell 3111199, Barcelona 8208
SpainSite Not Available
Hospital Universitario Marqués de Valdecilla ( Site 1906)
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla ( Site 1906)
Santander 3109718, Cantabria 3336898 39008
SpainSite Not Available
Hospital Clinico Universitario de Santiago ( Site 1903)
Santiago de Compostela, La Coruna 15706
SpainActive - Recruiting
Hospital Clinico Universitario de Santiago ( Site 1903)
Santiago de Compostela 3109642, La Coruna 15706
SpainSite Not Available
Hospital Universitari Vall d'Hebron ( Site 1901)
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron ( Site 1901)
Barcelona 3128760, 08035
SpainSite Not Available
The Princess Alexandra Hospital NHS Trust ( Site 2103)
Harlow, England CM20 1QX
United KingdomActive - Recruiting
The Princess Alexandra Hospital NHS Trust ( Site 2103)
Harlow 2647461, England 6269131 CM20 1QX
United KingdomSite Not Available
Chapel Allerton Hospital ( Site 2106)
Leeds, LS7 4SA
United KingdomActive - Recruiting
Chapel Allerton Hospital ( Site 2106)
Leeds 2644688, LS7 4SA
United KingdomSite Not Available
Barnet Hospital ( Site 2102)
London, EN5 3DJ
United KingdomActive - Recruiting
Barnet Hospital ( Site 2102)
London 2643743, EN5 3DJ
United KingdomSite Not Available
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
Glendale, Arizona 85306-9802
United StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
Mesa, Arizona 85210
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
Glendale 5295985, Arizona 5551752 85306-9802
United StatesSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
Mesa 5304391, Arizona 5551752 85210
United StatesSite Not Available
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
La Palma, California 90623
United StatesActive - Recruiting
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
La Palma 5364022, California 5332921 90623
United StatesSite Not Available
Tekton Research, LLC. ( Site 1008)
Fort Collins, Colorado 80528
United StatesActive - Recruiting
Tekton Research, LLC. ( Site 1008)
Fort Collins 5577147, Colorado 5417618 80528
United StatesSite Not Available
Sweet Hope Research Specialty, Inc ( Site 1015)
Hialeah, Florida 33016
United StatesActive - Recruiting
HMD Research LLC ( Site 1016)
Orlando, Florida 32819
United StatesActive - Recruiting
Sweet Hope Research Specialty, Inc ( Site 1015)
Hialeah 4158476, Florida 4155751 33016
United StatesSite Not Available
HMD Research LLC ( Site 1016)
Orlando 4167147, Florida 4155751 32819
United StatesSite Not Available
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)
Orland Park, Illinois 60467
United StatesActive - Recruiting
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)
Orland Park 4904937, Illinois 4896861 60467
United StatesSite Not Available
AA Medical Research Center ( Site 1027)
Grand Blanc, Michigan 48439
United StatesActive - Recruiting
AA Medical Research Center ( Site 1027)
Grand Blanc 4994320, Michigan 5001836 48439
United StatesSite Not Available
Kansas City Physician Partners ( Site 1032)
Kansas City, Missouri 64111
United StatesActive - Recruiting
Kansas City Physician Partners ( Site 1032)
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
Physician Research Collaboration, LLC ( Site 1002)
Lincoln, Nebraska 68516
United StatesActive - Recruiting
Physician Research Collaboration, LLC ( Site 1002)
Lincoln 5072006, Nebraska 5073708 68516
United StatesSite Not Available
altoona center for clinical research ( Site 1005)
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Rheumatology Specialty Center ( Site 1030)
Willow Grove, Pennsylvania 19090
United StatesActive - Recruiting
altoona center for clinical research ( Site 1005)
Duncansville 5187508, Pennsylvania 6254927 16635
United StatesSite Not Available
Rheumatology Specialty Center ( Site 1030)
Willow Grove 5219619, Pennsylvania 6254927 19090
United StatesSite Not Available
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)
Murfreesboro, Tennessee 37128
United StatesActive - Recruiting
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)
Murfreesboro 4644312, Tennessee 4662168 37128
United StatesSite Not Available
Rheumatology Associates ( Site 1026)
Arlington, Texas 76012
United StatesActive - Recruiting
Epic Medical Research ( Site 1004)
Red Oak, Texas 75154
United StatesActive - Recruiting
Advanced Rheumatology of Houston - Woodlands ( Site 1000)
The Woodlands, Texas 77382
United StatesActive - Recruiting
Rheumatology Associates ( Site 1026)
Arlington 4671240, Texas 4736286 76012
United StatesSite Not Available
Epic Medical Research ( Site 1004)
Red Oak 4721921, Texas 4736286 75154
United StatesSite Not Available
Advanced Rheumatology of Houston - Woodlands ( Site 1000)
The Woodlands 4736476, Texas 4736286 77382
United StatesSite Not Available

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