Clinical trial NCT02706847: A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Musculoskeletal Disease
Arthritis
Joint Disease
Anti-inflammatory agents
Antirheumatic agents
ABT-494
upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

Detailed description: This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo controlled treatment period (Period 1); a 236-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).

Period 1 consists of a 12-week double-blind, placebo-controlled treatment phase plus a 12-week double-blind phase where all participants were to receive upadacitinib; at Week 12 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups:

* Group 1: Upadacitinib 30 mg QD (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
* Group 2: Upadacitinib 15 mg QD (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
* Group 3: Placebo (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
* Group 4: Placebo (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)

Participants will continue stable dose of csDMARD therapy for the first 24 weeks of the study.

Participants who complete the Week 24 visit (end of Period 1) will enter the blinded long-term extension portion of the study, Period 2 and continue to receive the same dose of upadacitinib per original randomization assignment in a blinded manner. Starting at Week 24, at least 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline is required to remain on study drug. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed as per local label.

With the implementation of Protocol Amendment 4, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.
* Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
* Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
* Meets both of the following criteria:
* ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
* hsCRP ≥ 3mg/L at Screening Visit.

Exclusion Criteria:

* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia \[currently with active symptoms\]). Current diagnosis of secondary Sjogren's Syndrome is permitted.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
timeFrame: Baseline and week 1
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheum Assoc of North Alabama /ID# 145959
state: Alabama
city: Mesa
country: United States
facility: AZ Arthritis and Rheum Assoc /ID# 148593
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheum Researc /ID# 142816
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheum Researc /ID# 146075
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheum Researc /ID# 148592
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc. /ID# 142741
state: Arizona
city: Prescott
country: United States
facility: AZ Arthr & Rheum Research /ID# 155256
state: Arizona
city: Sun City
country: United States
facility: AZ Arthritis & Rheum Research /ID# 156090
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic /ID# 149280
state: Arkansas
city: Covina
country: United States
facility: Covina Arthritis Clinic /ID# 142794
state: California
city: Escondido
country: United States
facility: Rheumatology Ctr of San Diego /ID# 153576
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare /ID# 149273
state: California
city: La Mesa
country: United States
facility: TriWest Research Associates- La Mesa /ID# 142792
state: California
city: La Palma
country: United States
facility: Arthritis & Osteo Medical Ctr /ID# 142770
state: California
city: Los Alamitos
country: United States
facility: Valerius Med Grp & Res Ctr /ID# 142799
state: California
city: Los Angeles
country: United States
facility: Pacific Arthritis Ctr Med Grp /ID# 142783
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 148348
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances /ID# 142765
state: California
city: Stanford
country: United States
facility: Stanford University School of Med /ID# 142761
state: California
city: Tustin
country: United States
facility: Robin K. Dore MD, Inc /ID# 150908
state: California
city: Upland
country: United States
facility: Inland Rheum Clin Trials Inc. /ID# 142787
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research /ID# 142814
state: California
city: Colorado Springs
country: United States
facility: Arthritis Assoc & Osteo Ctr /ID# 142809
state: Colorado
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 142771
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates, LLC /ID# 142763
state: Connecticut
city: Lewes
country: United States
facility: Delaware Arthritis /ID# 142803
state: Delaware
city: Miami
country: United States
facility: Lakes Research, LLC /ID# 142755
state: Florida
city: Naples
country: United States
facility: Medallion Clinical Research Institute, LLC /ID# 142740
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants /ID# 142780
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research /ID# 142782
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida /ID# 142811
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc. /ID# 142822
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research /ID# 142817
state: Florida
city: Saint Petersburg
country: United States
facility: St. Anthony Comprehsve Res Ins /ID# 148349
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 145611
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group, Inc. /ID# 142747
state: Florida
city: Venice
country: United States
facility: Lovelace Scientific Resources /ID# 142779
state: Florida
city: Decatur
country: United States
facility: Jefrey D. Lieberman, MD, P.C. /ID# 151713
state: Georgia
city: Marietta
country: United States
facility: Marietta Rheumatology Assoc /ID# 151347
state: Georgia
city: Boise
country: United States
facility: St. Luke's Clinic - Rheumatolo /ID# 150923
state: Idaho
city: Idaho Falls
country: United States
facility: Institute of Arthritis Res /ID# 142810
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research /ID# 153089
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials /ID# 148341
state: Illinois
city: Skokie
country: United States
facility: Clinical Investigation Special /ID# 149270
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic /ID# 142818
state: Illinois
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates /ID# 151712
state: Illinois
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic, Inc. /ID# 142793
state: Louisiana
city: Shreveport
country: United States
facility: Vanguard Medical Research, LLC /ID# 153123
state: Louisiana
city: Portland
country: United States
facility: MMP Women's Health /ID# 145612
state: Maine
city: Wheaton
country: United States
facility: The Center for Rheumatology & /ID# 142742
state: Maryland
city: Mansfield
country: United States
facility: Mansfield Health Center /ID# 147628
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Gr /ID# 142744
state: Massachusetts
city: Lansing
country: United States
facility: June DO, PC /ID# 142756
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Med Clinics /ID# 142781
state: Mississippi
city: Saint Louis
country: United States
facility: Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745
state: Missouri
city: Saint Louis
country: United States
facility: Barbara Caciolo, MD /ID# 142749
state: Missouri
city: Omaha
country: United States
facility: Westroads Clinical Research /ID# 142802
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 145958
state: New Hampshire
city: Toms River
country: United States
facility: Atlantic Coast Research /ID# 148347
state: New Jersey
city: Toms River
country: United States
facility: Ocean Rheumatology, PA /ID# 142785
state: New Jersey
city: Albany
country: United States
facility: The Center for Rheumatology /ID# 142784
state: New York
city: New Hyde Park
country: United States
facility: North Shore University Hospital /ID# 142772
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology /ID# 142766
state: New York
city: Charlotte
country: United States
facility: Joint & Muscle Research Instit /ID# 142797
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC /ID# 142769
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care /ID# 148344
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care /ID# 148351
state: North Carolina
city: Raleigh
country: United States
facility: Shanahan Rheuma & Immuno /ID# 142812
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Med Arts Clinic /ID# 142754
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791
state: Ohio
city: Vandalia
country: United States
facility: STAT Research, Inc. /ID# 142821
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Oklahoma /ID# 142751
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultant /ID# 142815
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Assoc /ID# 142790
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Ctr Reading /ID# 151714
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Arthritis Center /ID# 153728
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Inst /ID# 142739
state: Tennessee
city: Kingsport
country: United States
facility: Arthritis Associates, PLLC /ID# 142774
state: Tennessee
city: Kingsport
country: United States
facility: Arthritis Associates, PLLC /ID# 155462
state: Tennessee
city: Memphis
country: United States
facility: Dr. Ramesh Gupta /ID# 142767
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc. /ID# 142805
state: Texas
city: Beaumont
country: United States
facility: Diagnostic Group Integrated He /ID# 148340
state: Texas
city: College Station
country: United States
facility: Arth and Osteo Clin Brazo Valley /ID# 148343
state: Texas
city: Dallas
country: United States
facility: Arthritis Care and Diagnostic /ID# 151344
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research /ID# 142758
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clin Res Ctr /ID# 150914
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine /ID# 142753
state: Texas
city: Houston
country: United States
facility: Rheumatology Clinic of Houston /ID# 150915
state: Texas
city: Houston
country: United States
facility: Houston Institute for Clin Res /ID# 142768
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc. /ID# 151346
state: Texas
city: Lubbock
country: United States
facility: Arthritis & Osteoporosis Assoc /ID# 147567
state: Texas
city: Lufkin
country: United States
facility: P&I Clinical Research /ID# 151345
state: Texas
city: Mesquite
country: United States
facility: SW Rheumatology Res. LLC /ID# 142813
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Association /ID# 149278
state: Texas
city: San Antonio
country: United States
facility: Arthritis & Osteo Ctr of S. TX /ID# 142773
state: Texas
city: San Marcos
country: United States
facility: Arthritis Clinic of Central TX /ID# 148346
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research /ID# 151007
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic /ID# 142760
state: Texas
city: Bothell
country: United States
facility: Western Washington Arthritis C /ID# 142776
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC /ID# 150924
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic, INC. PS /ID# 147946
state: Washington
city: South Charleston
country: United States
facility: West Virginia Research Inst /ID# 153087
state: West Virginia
city: Franklin
country: United States
facility: Aurora Rheumatology and Immunotherapy Center /ID# 142820
state: Wisconsin
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital /ID# 142419
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 142416
state: Victoria
city: Vienna
country: Austria
facility: Medizinische Universität Wien /ID# 142424
state: Wien
city: Graz
country: Austria
facility: Universitaetsklinik fuer Inner /ID# 142423
city: Vienna
country: Austria
facility: Rheuma Zentrum Favoriten GmbH /ID# 142421
city: Wien
country: Austria
facility: Rheuma-Zentrum Wien-Oberlaa /ID# 142425
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien /ID# 142422
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 142426
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Rhumaconsult SPRL /ID# 151378
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent /ID# 142429
state: Oost-Vlaanderen
city: Genk
country: Belgium
facility: ReumaClinic Genk /ID# 142431
city: Oostende
country: Belgium
facility: AZ Damiaan /ID# 142427
city: Winnipeg
country: Canada
facility: Ciads /Id# 142526
state: Manitoba
city: Ostrava
country: Czechia
facility: Revmatologie MUDr. Klara Sirova /ID# 142536
city: Uherské Hradište
country: Czechia
facility: Medical Plus, s.r.o. /ID# 148345
city: Tartu
country: Estonia
facility: MediTrials /ID# 151777
state: Tartumaa
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital /ID# 142543
city: Hyvinkaa
country: Finland
facility: Kiljava Medical Research /ID# 142546
city: Lahti
country: Finland
facility: Paijat-Hame Central Hospital /ID# 149185
city: Orleans CEDEX 2
country: France
facility: CHR Orleans - Hopital de la Source /ID# 142557
state: Centre-Val De Loire
city: Toulouse
country: France
facility: Hopital Universitaire Purpan /ID# 144697
state: Haute-Garonne
city: Montpellier CEDEX 5
country: France
facility: Hopital Saint Eloi /ID# 142552
state: Herault
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier Le Mans /ID# 145956
state: Sarthe
city: Bordeaux
country: France
facility: CHU Bordeaux-Hopital Pellegrin /ID# 144700
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougie /ID# 142556
city: Lyon
country: France
facility: Hopital Edouard Herriot /ID# 144698
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 145600
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Koln /ID# 142563
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Campus Mitte /ID# 142559
city: Hamburg
country: Germany
facility: Rheumaforschungszentrum II /ID# 142560
city: Hamburg
country: Germany
facility: Schoen Klinikum Hamburg Eilbek /ID# 142566
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona /ID# 142561
city: Munich
country: Germany
facility: LMU Klinikum der Universität München /ID# 142564
city: Planegg
country: Germany
facility: MVZ Planegg /ID# 142565
city: Püttlingen
country: Germany
facility: Knappschaftsklinikum Saar /ID# 142562
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 142579
state: Attiki
city: Veszprém
country: Hungary
facility: Vital Medical Center Orvosi es /ID# 142586
state: Veszprem
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo /ID# 142590
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korh /ID# 142588
city: Dublin
country: Ireland
facility: St Vincent's University Hosp /ID# 142593
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Ctr /ID# 142597
state: Tel-Aviv
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 151945
city: Haifa
country: Israel
facility: The Lady Davis Carmel MC /ID# 142599
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospi /ID# 150883
state: Seongdong-gu
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital /ID# 150881
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 142622
city: Adazi
country: Latvia
facility: LTD M+M Centers /ID# 142624
city: Riga
country: Latvia
facility: P. Stradins Clinical Univ Hosp /ID# 142623
city: Riga
country: Latvia
facility: Arthritis Clinic Ltd /ID# 153560
city: Timaru
country: New Zealand
facility: Timaru Medical Specialists Ltd /ID# 142657
city: Wrocław
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow /ID# 142664
state: Malopolskie
city: Warsaw
country: Poland
facility: Centrum Medyczne Pratia Warszawa /ID# 142667
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa Targowek /ID# 142663
state: Mazowieckie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia /ID# 142666
state: Pomorskie
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar De Vila Nova /ID# 142670
state: Porto
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE /ID# 142668
city: San Juan
country: Puerto Rico
facility: GCM Medical Group /ID# 142671
city: Korolev
country: Russian Federation
facility: Family Outpatient clinic#4,LLC /ID# 150910
state: Moskva
city: Kosice
country: Slovakia
facility: ARTROMAC n.o. /ID# 142692
city: Kosice
country: Slovakia
facility: Nemocnica Kosice Saca, a.s. /ID# 142693
city: Pieštany
country: Slovakia
facility: Narodny ustav reumatickych chorob Piestany /ID# 142691
city: Santander
country: Spain
facility: H. Un. Marques de Valdecilla /ID# 142706
state: Cantabria
city: Málaga
country: Spain
facility: Hospital Regional de Malaga /ID# 142707
state: Malaga
city: A Coruna
country: Spain
facility: Comple Hosp Univ de A Coruna /ID# 142708
city: Madrid
country: Spain
facility: Hospital Clin Univ San Carlos /ID# 142711
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias /ID# 142709
city: Valencia
country: Spain
facility: Hospital Universitario La Fe /ID# 142716
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hosp /ID# 142720
city: Halmstad
country: Sweden
facility: Capio Movement Halmstad /ID# 148236
city: Orebro
country: Sweden
facility: Orebro Universitetssjukhuset /ID# 142718
city: Vasteras
country: Sweden
facility: Vastmanlands Sjukhus /ID# 142721
city: Basel
country: Switzerland
facility: Universitaetsspital Basel /ID# 145610
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hopital Canton /ID# 142723
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty /ID# 142729
city: Ankara
country: Turkey
facility: Ankara Ataturk Training & Res /ID# 142727
city: Samsun
country: Turkey
facility: Ondokuz mayis University Facul /ID# 142728
city: London
country: United Kingdom
facility: Whipps Cross Univ Hospital /ID# 145957
state: London, City Of
city: London
country: United Kingdom
facility: The Royal Free Hospital /ID# 142733
state: London, City Of
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospitals NHS Trust /ID# 148992
city: Edinburgh
country: United Kingdom
facility: Western General Hospital /ID# 142732
city: Ipswich
country: United Kingdom
facility: West Suffolk Hospital /ID# 148993
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital /ID# 142735
city: Wirral
country: United Kingdom
facility: Arrowe Park Hospital /ID# 148991
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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citation: Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.