A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis (UPHOLD)

Upadacitinib Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Moderate to Severe Rheumatoid Arthritis Patients in Real-World Practice (UPHOLD)

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the treatment patterns, achievement of treatment targets and maintenance of response.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide.

Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months.

There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis (RA)

• Study Type: Observational
• Enrollment (Actual): 1532

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5000
    • Instituto Medico Strusberg /ID# 222189
  • San Miguel de Tucuman, Argentina, 4000
    • Cimer /Id# 222188
  • Santiago Del Estero, Argentina, 4200
    • Instituto de Cardiologia /ID# 226634
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1902
      • Hospital Italiano La Plata /ID# 222190
    • Quilmes, Buenos Aires, Argentina, 1878
      • CER Instituto Medico /ID# 222193
  • Ciuadad Autonoma De Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1015
      • Organizacion Medica de Investigacion (OMI) /ID# 222187
    • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1055
      • CIER Centro de Investigaciones en Enfermedades Reumaticas /ID# 231769
    • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1111
      • DOM Centro de Reumatologia /ID# 222194
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto CAICI S.R.L /ID# 222191
• Australia
  • Adelaide, Australia, 5000
    • Private Practice - Scott Walter Graf /ID# 223958
  • New South Wales
    • Broadmeadow, New South Wales, Australia, 2292
      • Genesis Research Services /ID# 224060
    • Paramatta, New South Wales, Australia, 2150
      • BJC Health /ID# 223884
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research /ID# 223883
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Joint West Rheumatology /ID# 223886
• Austria
  • Kaernten
    • Klagenfurt Am Woerthersee, Kaernten, Austria, 9020
      • Klinikum Klagenfurt am Woerthersee /ID# 239628
  • Niederoesterreich
    • Hollabrunn, Niederoesterreich, Austria, 2020
      • Ordination Dr. Leeb /ID# 224293
  • Steiermark
    • Gleisdorf, Steiermark, Austria, 8200
      • Dr. Georg Kurtz /ID# 225477
  • Wien
    • Vienna, Wien, Austria, 1010
      • Dr. Maya Thun /ID# 224299
    • Vienna, Wien, Austria, 1090
      • Ordination Doz. Grisar /ID# 224298
    • Vienna, Wien, Austria, 1100
      • Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 227853
• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Hospital /ID# 223042
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge /ID# 223713
  • Brugge, Belgium, 8310
    • AZ Sint Lucas /ID# 223093
  • Genk, Belgium, 3600
    • Reumacentrum /ID# 222799
  • Genk, Belgium, 3600
    • ReumaClinic /ID# 221353
  • Gistel, Belgium, 8470
    • Maertens, Gistel, BE /ID# 221823
  • Hasselt, Belgium, 3500
    • Reuma Instituut Hasselt /ID# 221822
  • Liege, Belgium, 4000
    • CHU de Liege /ID# 222201
  • Sijsele, Belgium, 8340
    • AZ Alma Campus Sijsele /ID# 222214
  • Sint-Niklaas, Belgium, 9100
    • Private practice Sint-Niklaas /ID# 224123
  • Bruxelles-Capitale
    • Bruxelles, Bruxelles-Capitale, Belgium, 1000
      • CHU Saint Pierre /ID# 223041
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Rhumaconsult SPRL /ID# 221825
  • Namur
    • Godinne, Namur, Belgium, 5530
      • CHU UCL Namur - site Godinne /ID# 222797
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Algemeen Stedelijk Ziekenhuis /ID# 224121
• France
  • Aix En Provence Cedex 1, France, 13616
    • CH du Pays d'AIX /ID# 229561
  • Aix les Bains, France, 73100
    • Cabinet medical /ID# 225366
  • Albi, France, 81000
    • Cabinet medical /ID# 224850
  • Angouleme CEDEX 9, France, 16959
    • Centre Hospitalier d'Angouleme /ID# 226064
  • Annecy, France, 74000
    • Cabinet Novel d'Annecy /ID# 232310
  • Arras, France, 62022
    • Centre Hospitalier d'Arras /ID# 223172
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hopital Pellegrin /ID# 224837
  • Boulogne sur Mer, France, 62200
    • Centre Hospitalier de Boulogne Sur Mer /ID# 222991
  • Brest, France, 29200
    • Hopital de la Cavale Blanche /ID# 222462
  • Caen, France, 14000
    • cabinet liberal- Dr CORNILLE /ID# 227869
  • Cahors, France, 46005
    • Centre Hospitalier Jean Rougie /ID# 224242
  • Chambray Les Tours, France, 37170
    • CHRU Tours - Hopital Trousseau /ID# 222445
  • Cholet, France, 49300
    • Centre Hospitalier de CHOLET /ID# 222455
  • Clamart, France, 92190
    • Hia Percy /Id# 225642
  • Clermont Ferrand, France, 63000
    • CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 223801
  • Compiegne, France, 60200
    • Cabinet liberal - Compiegne - Dr Banse /ID# 227099
  • Corbeil Essonnes, France, 91106
    • C. H. Sud Francilien /ID# 222446
  • Haguenau, France, 67500
    • Cabinet medical /ID# 225142
  • La Roche Sur Yon, France, 85000
    • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 229086
  • La Rochelle, France, 17019
    • CH La Rochelle - Hopital Saint Louis /ID# 224240
  • La Tronche, France, 38700
    • CHU Grenoble - Hopital Michallon /ID# 223211
  • Laon CEDEX, France, 02001
    • Centre Hospitalier de Laon /ID# 224857
  • Le Puy en Velay, France, 43000
    • CH Emile Roux Le Puy en Velay /ID# 223688
  • Les Abrets En Dauphine, France, 38490
    • Cabinet médical /ID# 225000
  • Lille, France, 59037
    • CHU Lille - Hôpital Roger Salengro /ID# 223170
  • Lyon, France, 69009
    • Clinique de la Sauvegarde /ID# 223424
  • Mennecy, France, 91540
    • Cabinet de rhumatologie /ID# 227740
  • Monaco, France, 98000
    • CH Princesse Grace /ID# 222451
  • Montauban, France, 82000
    • Ch Montauban /Id# 231854
  • Montauban, France, 82000
    • ELSAN - Clinique du Pont de Chaume /ID# 224898
  • Montpellier, France, 34070
    • Clinique Beau Soleil /ID# 224238
  • Morlaix, France, 29600
    • CH des Pays de Morlaix /ID# 223795
  • Moulins, France, 03000
    • Polyclinique saint Odilon /ID# 225576
  • Mulhouse, France, 68100
    • Ch Mulhouse /Id# 223442
  • Paris, France, 75012
    • AP-HP - Hopital Saint-Antoine /ID# 222441
  • Paris, France, 75013
    • Hopital Pitie Salpetriere /ID# 222443
  • Paris, France, 75014
    • AP-HP - Hopital Cochin /ID# 222986
  • Paris, France, 75014
    • Cabinet medical /ID# 224855
  • Paris, France, 75015
    • Centre de Soins Osteoarticulaires Ambulatoires /ID# 224737
  • Paris, France, 75018
    • AP-HP - Hopital Bichat - Claude-Bernard /ID# 222449
  • Paris, France, 75020
    • GH Diaconesses Croix Saint-Simon /ID# 229126
  • Reims, France, 51100
    • Cabinet médical /ID# 225321
  • Rennes CEDEX 2, France, 35203
    • CHU de Rennes - Hospital Sud /ID# 222458
  • Roanne, France, 42300
    • CH Roanne /ID# 224729
  • Rouen, France, 76000
    • Clinique Saint-Hilaire /ID# 223833
  • Rouen, France, 76000
    • Hôpital Charles-Nicolle /ID# 223589
  • Saint-Mandé cedex, France, 94163
    • Hôpital d'instruction des armées Bégin /ID# 222440
  • Sainte Maxime, France, 83120
    • Cabinet rhumatologie Dr NECTOUX /ID# 225828
  • St Michel Sur Orge, France, 91240
    • Cabinet Rhumatologie St Michel Sur Orge /ID# 225176
  • St Nazaire, France, 44600
    • CH Saint Nazaire /ID# 225750
  • Strasbourg, France, 67000
    • Groupe Médical Spécialisé - Le Premium /ID# 223719
  • Thionville, France, 57100
    • Cabinet de Rhumatologie Poincare /ID# 224755
  • Alpes-Maritimes
    • Cannes CEDEX, Alpes-Maritimes, France, 06414
      • CH Cannes - les Broussailles /ID# 226160
  • Auvergne-Rhone-Alpes
    • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
      • HCL - Hopital Lyon Sud /ID# 222447
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67200
      • CHU Strasbourg - Hopital de Hautepierre /ID# 222450
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13008
      • Hopital Saint Joseph /ID# 227221
  • Cote-d Or
    • Dijon, Cote-d Or, France, 21000
      • CHU Dijon /ID# 223799
  • Deux-Sevres
    • Niort CEDEX, Deux-Sevres, France, 79028
      • CH Georges Renon /ID# 225197
  • Doubs
    • Besancon, Doubs, France, 25030
      • CHU de Besancon - Jean Minjoz /ID# 222463
  • Franche-Comte
    • Limoges CEDEX 1, Franche-Comte, France, 87042
      • CHU Limoges - Dupuytren 1 /ID# 222457
  • Haute-Garonne
    • TOULOUSE Cedex 9, Haute-Garonne, France, 31059
      • CHU Toulouse - Hopital Purpan /ID# 223150
  • Hautes-Pyrenees
    • Tarbes CEDEX 9, Hautes-Pyrenees, France, 65013
      • CH Bigorre - Site de la Gespe /ID# 225141
  • Hauts-de-France
    • Roubaix Cedex 1, Hauts-de-France, France, 59100
      • CH Roubaix - Hopital Victor Provo /ID# 225032
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint Eloi /ID# 222452
    • Montpellier Cedex 5, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint Eloi /ID# 223394
  • Ile-de-France
    • Bobigny, Ile-de-France, France, 93000
      • Hopital Avicenne - APHP /ID# 224248
  • Loire
    • St. Priest En Jarez, Loire, France, 42270
      • CHU de SAINT ETIENNE - Hopital Nord /ID# 222456
  • Loiret
    • Orleans CEDEX 2, Loiret, France, 45067
      • CHR Orleans - Hopital de la Source /ID# 223591
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 225787
  • Provence-Alpes-Cote-d Azur
    • Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002
      • CHU Nice -Hopital Pasteur /ID# 222460
  • Rhone
    • Caluire Et Cuire, Rhone, France, 69300
      • Infirmerie Protestante /ID# 222438
  • Somme
    • Amiens CEDEX 1, Somme, France, 80054
      • CHU Amiens-Picardie Site Sud /ID# 222444
    • Peronne, Somme, France, 80200
      • Cabinet libéral du Dr PAUPIERE /ID# 238723
• Germany
  • Baden-baden, Germany, 76530
    • ACURA Rheumazentrum Baden-Bade /ID# 225225
  • Bamberg, Germany, 96047
    • Rheumapraxis Prof Dr Karin Manger /ID# 224086
  • Berlin, Germany, 12163
    • Praxis fuer Rheumatologie und Innere Medizin /ID# 225222
  • Braunschweig, Germany, 38100
    • Eisterhues, Braunschweig, DE /ID# 225186
  • Cologne, Germany, 50825
    • Rheumatologie in Veedel /ID# 224999
  • Cologne, Germany, 50996
    • Dres. Karger/Baerlecken /ID# 224809
  • Ehringshausen, Germany, 35630
    • Praxis Dilltal /ID# 226925
  • Erfurt, Germany, 99096
    • MVZ Ambulantes Rheumazentrum Erfurt /ID# 224812
  • Gommern, Germany, 39245
    • Helios Fachklinik Vogelsang-Gommern /ID# 222949
  • Heidelberg, Germany, 69120
    • Heilig, Heidelberg, DE /ID# 225223
  • Leipzig, Germany, 04129
    • Praxis internistische Rheumatologie /ID# 239226
  • Leverkusen, Germany, 51373
    • Dres. Teipel/Toussaint/Saech /ID# 226923
  • Magdeburg, Germany, 39104
    • Aurich & Sieburg, Magdeburg /ID# 230701
  • Pfarrkirchen, Germany, 84347
    • Die Fachaerzte im Rottal - Nephrologie, Rheumatologie /ID# 223866
  • Planegg, Germany, 82152
    • MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 226926
  • Puettlingen, Germany, 66346
    • Knappschaftsklinikum Saar /ID# 225224
  • Trier, Germany, 54292
    • Krankenhaus der Barmherzigen Brueder Trier /ID# 226927
  • Tuebingen, Germany, 72072
    • Praxis Dr. Haas /ID# 225187
  • Brandenburg
    • Templin, Brandenburg, Germany, 17268
      • Rheumatologische-Immunologische Praxis Templin /ID# 226924
• Greece
  • Athens, Greece, 11521
    • Naval Hospital of Athens /ID# 224135
  • Patras, Greece, 26335
    • General Hospital of Patras Agios Andreas /ID# 224132
  • Patras, Greece, 26443
    • Olympion General Clinic SA /ID# 224130
  • Thessaloniki, Greece, 54622
    • Bioclinic Thessaloniki /ID# 224879
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki Hippokrateio /ID# 229965
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic /ID# 224134
  • Attiki
    • Athens, Attiki, Greece, 11525
      • 251 Airforce General Hospital /ID# 225065
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Gennimatas /ID# 225064
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Ippokratio /ID# 224164
    • Athens, Attiki, Greece, 12462
      • University General Hospital Attikon /ID# 224136
    • Athens, Attiki, Greece, 16673
      • General Hospital Asklepieio Voulas /ID# 224131
  • Evros
    • Alexandroupoli, Evros, Greece, 68100
      • University General Hospital of Alexandroupolis /ID# 224880
  • Kriti
    • Heraklion, Kriti, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 224133
• Ireland
  • Dublin
    • Dublin 20, Dublin, Ireland, D20 W722
      • Hermitage Medical Clinic /ID# 239556
    • Dublin 8, Dublin, Ireland, D08 NHY1
      • St James Hospital /ID# 224201
    • Elm Park, Dublin, Ireland, D04 T6F4
      • St Vincent's University Hospital /ID# 224200
    • Tallaght, Dublin, Ireland, D24 NR0A
      • Tallaght University Hospital /ID# 231260
• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center /ID# 222138
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center /ID# 222170
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 222118
  • Haifa, Israel, 34362
    • The Lady Davis Carmel Medical Center /ID# 223851
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 222116
  • Nahariya, Israel, 2210001
    • Galilee Medical Center /ID# 222113
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 222694
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 222034
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 222117
• Italy
  • Alessandria, Italy, 15121
    • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 228889
  • Ancona, Italy, 60126
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 229440
  • Bari, Italy, 70124
    • Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 228580
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 228967
  • Brescia, Italy, 25123
    • ASST Spedali civili di Brescia /ID# 228970
  • Chieti, Italy, 66100
    • Ospedale Ss. Annunziata /ID# 228809
  • Milan, Italy, 20122
    • ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 228556
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda /ID# 228807
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena /ID# 228554
  • Napoli, Italy, 80138
    • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 229057
  • Napoli, Italy, 80144
    • Ospedale San Giovanni Bosco /ID# 228552
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Civico Di Cristina Benfratelli- P.O. Civico /ID# 228912
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228160
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico /ID# 227937
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 228550
  • Potenza, Italy, 85100
    • Azienda Ospedaliera Regionale San Carlo /ID# 228648
  • Rome, Italy, 00189
    • Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 227942
  • Salerno, Italy, 84131
    • Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 229065
  • Siena, Italy, 53100
    • Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 227938
  • Turin, Italy, 10128
    • A.0.Ordine Mauriziano/Ospedale Umberto I di Torino /ID# 228888
  • Udine, Italy, 33100
    • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228551
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Trento /ID# 228553
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 228788
  • Genova
    • Arenzano, Genova, Italy, 16011
      • ASL 3 Genovese - Ospedale la Colletta /ID# 228892
  • Lazio
    • Rome, Lazio, Italy, 00128
      • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 229063
    • Rome, Lazio, Italy, 00161
      • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 228014
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 229061
  • Milano
    • Milan, Milano, Italy, 20132
      • Ospedale San Raffaele IRCCS /ID# 229059
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas /ID# 227943
• Kuwait
  • Hawalli, Kuwait, 46300
    • Mubarak Hospital /ID# 224139
  • Kuwait, Kuwait, 60000
    • KOC Hospital /ID# 224138
  • Kuwait City, Kuwait, 35002
    • Ameeri Hospital /ID# 224140
• Mexico
  • Mexico City, Mexico, 11650
    • Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 224360
  • Puebla, Mexico, 72550
    • Consultorio Privado Jorge Rojas Serrano /Id# 243258
  • Ciudad De Mexico
    • Mexico City, Ciudad De Mexico, Mexico, 03100
      • RM Pharma Specialists S.A de C.V. /ID# 224359
    • Mexico City, Ciudad De Mexico, Mexico, 11850
      • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 240836
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatologia S.A de C.V /ID# 224363
    • Guadalajara, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 224361
    • Guadalajara, Jalisco, Mexico, 44650
      • Private Office Dr. Orozco /ID# 243257
    • Guadalajara, Jalisco, Mexico, 44690
      • Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 224364
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Consultorio Medico Privado - Miryam Eguia Bernal /Id# 243255
• Russian Federation
  • Khanty-Mansyisk, Russian Federation, 628011
    • District clinical hospital /ID# 227662
  • Moscow, Russian Federation, 123182
    • City Clinical Hospital #52 /ID# 242947
  • Omsk, Russian Federation, 644111
    • Omsk Regional Clinic Hospital /ID# 232029
  • Orenburg, Russian Federation, 460000
    • Orenburg State Medical University /ID# 243615
  • Petrozavodsk, Russian Federation, 185019
    • Republican hospital named after V.A. Baranov /ID# 227661
  • Samara, Russian Federation, 443079
    • Clinic of Samara State Medical University /ID# 241168
  • St. Petersburg, Russian Federation, 190068
    • Clinical Rheumatologic Hospital No 25 /ID# 242475
  • St. Petersburg, Russian Federation, 194044
    • Military Medical Academy n.a. Kirov /ID# 242351
  • Surgut, Russian Federation, 628400
    • Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra "Surgut Dist /ID# 243313
  • Tomsk, Russian Federation, 634009
    • Nebbiolo Clinical Research Center /ID# 224900
  • Ulyanovsk, Russian Federation, 432017
    • Ulyanovsk Regional Clinical Hospital /ID# 239164
  • Voronezh, Russian Federation, 394036
    • Voronezh State Medical Univers /ID# 224854
  • Yaroslavl, Russian Federation, 150000
    • Yaroslavl State Medicat University /ID# 224851
  • Komi, Respublika
    • Syktyvkar, Komi, Respublika, Russian Federation, 167031
      • LLC MC RevmaMed /ID# 239162
  • Moskovskaya Oblast
    • Moscow, Moskovskaya Oblast, Russian Federation, 129110
      • Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 224852
  • Samarskaya Oblast
    • Samara, Samarskaya Oblast, Russian Federation, 443095
      • Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 227852
  • Sankt-Peterburg
    • St. Petersburg, Sankt-Peterburg, Russian Federation, 193015
      • Nort-Western State Medical University n.a. Mechnikov /ID# 223419
  • Tyumenskaya Oblast
    • Tyumen, Tyumenskaya Oblast, Russian Federation, 625032
      • GBUZ TO Regional Clinical Hospital No. 1 /ID# 241113
• Saudi Arabia
  • Jeddah, Saudi Arabia, 22236
    • Saudi German Hospital Jeddah /ID# 243234
  • Jeddah, Saudi Arabia, 22252
    • King Abdulaziz University Hospital /ID# 222724
  • Jeddah, Saudi Arabia, 22382
    • International Medical Center /ID# 243235
  • Mushait, Saudi Arabia, 61961
    • Saudi German Hospital /ID# 224137
  • Riyadh, Saudi Arabia, 11525
    • King Fahad Medical City /ID# 222917
• Spain
  • A Coruna, Spain, 15006
    • Hospital Universitario A Coruna - CHUAC /ID# 231818
  • Almeria, Spain, 04009
    • Hospital Universitario Torrecardenas /ID# 241931
  • Badajoz, Spain, 06010
    • Hospital Perpetuo Socorro /ID# 231827
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 240000
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 231821
  • Barcelona, Spain, 08042
    • Hospital General de Granollers /ID# 238778
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia /ID# 231843
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves /ID# 231841
  • Huelva, Spain, 21005
    • Hospital Juan Ramon Jimenez /ID# 231840
  • Jaen, Spain, 23007
    • Hospital Universitario de Jaen /ID# 231842
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 241901
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 240150
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 231837
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 231836
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme /ID# 231838
  • Zaragoza, Spain, 50015
    • Hospital Royo Villanova /ID# 231824
  • Badajoz
    • Mérida, Badajoz, Spain, 06800
      • Hospital de Mérida /ID# 231826
  • Barcelona
    • Terrasa, Barcelona, Spain, 08221
      • Hospital Universitario Mutua Terrassa /ID# 231822
    • Viladecans, Barcelona, Spain, 08840
      • Hospital de Viladecans /ID# 231823
  • Caceres
    • Plasencia, Caceres, Spain, 10600
      • Hospital Virgen del Puerto /ID# 240149
  • Cadiz
    • Jerez de la Frontera, Cadiz, Spain, 11407
      • Hospital Universitario de Jerez de la Frontera /ID# 231844
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Hospital Universitario de Getafe /ID# 231825
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Hospital General Universitario Santa Lucia /ID# 238780
    • El Palmar, Murcia, Spain, 30120
      • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 231847
    • Lorca, Murcia, Spain, 30817
      • Hospital Rafael Mendez /ID# 231846
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36204
      • Hospital Xeral Cies (CHUVI) /ID# 231819
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario Canarias /ID# 231848
  • Zaragoza
    • Calatayud, Zaragoza, Spain, 50299
      • Hospital Ernest Lluch Martin /ID# 238779
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern /ID# 224951
  • Fribourg, Switzerland, 1708
    • HFR Fribourg - Hôpital cantonal /ID# 224163
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG /ID# 222354
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitätsspital Basel /ID# 224160
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 224158
  • Thurgau
    • Weinfelden, Thurgau, Switzerland, 8570
      • Rheumatologisches Versorgungszentrum Weinfelden /ID# 222346
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV, Centre hospitalier universitaire vaudois /ID# 224161
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241052
  • Taichung City, Taiwan, 40447
    • China Medical University Hospital /ID# 241051
  • Tainan, Taiwan, 71004
    • Chi-Mei Medical Center /ID# 241745
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 241050
  • Taipei City, Taiwan, 11490
    • Tri-Service General Hospital /ID# 241746
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 241053
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Cleveland Clinic Abu Dhabi /ID# 223176
  • Dubai, United Arab Emirates, 334224
    • Integrated Rheumatology and Arthritis Center /ID# 223177
  • Dubai, United Arab Emirates
    • Departnent of Medicine-Rheumatology Al Baraha Hospital and Al Qasmi Hospital Min /ID# 223178
  • Dubai, United Arab Emirates
    • Drt Sulaiman Al Habib Hospital /ID# 226575
• Uruguay
  • Montevideo, Uruguay, 11200
    • Asociacion Española /ID# 222009
  • Montevideo, Uruguay, 11600
    • Medica Uruguaya /ID# 222008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA).

Description

Inclusion Criteria:

• Confirmed diagnosis of moderate to severe active Rheumatoid Arthritis (RA).
• Physician decision on patient treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
• Upadacitinib prescribed in accordance to the applicable approved label and local regulatory and reimbursement policies.
• French Participants Only: Taking oral glucocorticoids ≥5 mg/day of prednisone or equivalent for at least 3 months prior to study start.

Exclusion Criteria:

- Prior treatment with Upadacitinib.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants receiving Upadacitinib; Participants receiving Upadacitinib for moderate to severe rheumatoid arthritis (RA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve Remission	Remission is defined as Disease Activity Score at 28 joints (DAS28) C-reactive Protein (CRP)<2.6.	At Month 6
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission	Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.	At Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission	Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.	At Month 24
Percentage of Participants Who Achieve Low Disease Activity (LDA) at 6 months that maintain LDA	LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.	Through Month 24
Percentage of Participants Who Achieve Remission at 3 Months and Maintain Remission	Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.	Through Month 24
Percentage of Participants Who Achieve Remission at 6 Months and Maintain Remission Grouped by Glucocorticoid Dose	Remission is defined as DAS28-CRP<2.6. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.	At Month 12
Percentage of Participants Who Achieve LDA at 3 months that maintain LDA Grouped by Glucocorticoid Dose	LDA is defined as DAS28-CRP≤3.2. Maintaining remission is defined as no more than 0.6 point increase in DAS28-CRP.	Through Month 6
Percentage of Participants in LDA that Achieve Glucocorticoid Dose <5 mg/Day Per Visit	LDA is defined as DAS28-CRP<3.2.	Through Month 24
Percentage of Participants in Remission that Achieve Glucocorticoid Dose <5 mg/Day Per Visit	Remission is defined as DAS28-CRP<2.6.	Through Month 24
Percentage of Participants Who Achieved a Glucocorticoid Dose <5 mg/Day Without Conventional Synthetic Disease Modifying Anti Rheumatic Drug (csDMARD) Intensification	Percentage of participants who achieved a glucocorticoid dose <5 mg/day without csDMARD intensification.	At Month 6
Percentage of Participants Who Initiated Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) That Moved to Monotherapy (+/- Glucocorticoids)	Percentage of participants who initiated Upadacitinib as combination therapy (csDMARD +/- Glucocorticoids) that moved to monotherapy (+/- glucocorticoids).	Through Week 24
Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Combination Therapy Strategy	Remission is defined as DAS28-CRP<2.6.	Through Month 24
Of the Participants Initiating Upadacitinib as Combination Therapy (csDMARD +/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Combination Therapy Strategy	LDA is defined as DAS28-CRP<3.2.	Through Month 24
Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve Remission at 6 months, the Percentage of Participants that Maintain Remission Grouped by Maintenance of Monotherapy	Remission is defined as DAS28-CRP<2.6.	Through Month 24
Of the Participants Initiating Upadacitinib as Monotherapy Therapy (+/- Glucocorticoids) and Achieve LDA at 6 months, the Percentage of Participants that Maintain LDA Grouped by Maintenance of Monotherapy	LDA is defined as DAS28-CRP<3.2.	Through Month 24
Percentage of Participants Who Do Not Achieve Remission at Any Point in the Study	Remission is defined as DAS28-CRP<2.6.	Through Month 24
Time to the Discontinuation of Upadacitinib	Time to the discontinuation of Upadacitinib.	Through Month 24
Time to First Treatment Adjustment	Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal.	Baseline (Month 0) Through Month 24
Percentage of Participants Achieving LDA Grouped by Therapy Strategy	LDA is defined as DAS28-CRP<3.2, Simplified Disease Activity Index (SDAI) ≤11 and Clinical Disease Activity Index (CDAI) ≤10.	Through Month 24
Percentage of Participants Achieving Remission Grouped by Therapy Strategy	Remission is defined as DAS28-CRP<2.6, SDAI≤3.3 and CDAI ≤2.8.	Through Month 24
Change in Medication Burden Treatment Burden Questionnaire (TBQ) in Participants, Grouped by Therapy Strategy	The TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem), to 10 (big problem). scores can be summed into a global score, ranging from 0 to 130.	Through Week 24
Change in Physical Function Health Assessment Questionnaire - Disability Index (HAQ-DI) in Participants, Grouped by Therapy Strategy	HAQ is a widely accepted, validated, rheumatology specific instrument to assess physical function in Rheumatoid Arthritis. It consists of 20 questions, covering eight types of activities. For each question, scores range from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty or with assistance; 3 = unable to do). HAQ Disability Index (HAQ-DI) score is the average of the highest score in each of the eight categories.	Baseline (Month 0) Through Month 24
Change in Pain Visual Analogue Scale (VAS) in participants, Grouped by Therapy Strategy	A VAS is used to assess worst joint pain in the past 7 days.	Baseline (Month 0) Through Month 24
Change in Morning Stiffness in Participants, Grouped by Therapy Strategy	A numeric rating scale (NRS) is used to assess severity and length of morning stiffness in the past 7 days.	Baseline (Month 0) Through Month 24
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) in Participants, Grouped by Therapy Strategy	The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four-point Likert scale (0 = not at all fatigued to 4 = very much fatigued).	Baseline (Month 0) Through Month 24

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Anticipated): May 15, 2024
• Study Completion (Anticipated): May 15, 2024

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Upadacitinib; RINVOQ
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: P20-095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No