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

Rheumatoid Arthritis (RA) Clinical Trial

— UPHOLD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04497597
• Other study ID #: P20-095
• Status: Active, not recruiting
• Start date: October 16, 2020
• Est. completion date: May 15, 2024

Study information

• Verified date: January 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1532
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Kuwait,  Mexico,  Russian Federation,  Saudi Arabia,  Spain,  Switzerland,  Taiwan,  United Arab Emirates,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to the Discontinuation of Upadacitinib	Time to the discontinuation of Upadacitinib.	Through Month 24
Secondary	Time to First Treatment Adjustment	Treatment Adjustment is defined as treatment escalation/de-escalation/ addition/withdrawal.	Baseline (Month 0) Through Month 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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