NCT03104400

Brief Summary

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,705

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_3

Geographic Reach
43 countries

338 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

April 27, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 25, 2022

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

April 4, 2017

Results QC Date

December 27, 2021

Last Update Submit

September 2, 2025

Conditions

Keywords

ArthritisPsoriasisAnti-inflammatoryJoint diseaseMusculoskeletal diseaseAnti-Rheumatic

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

    Baseline and Week 12

Secondary Outcomes (17)

  • Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

    Baseline and Week 12

  • Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16

    Baseline and Week 16

  • Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16

    Baseline and Week 16

  • Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24

    Baseline and Week 24

  • Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24

    Week 24

  • +12 more secondary outcomes

Study Arms (5)

Upadacitinib 15 mg

EXPERIMENTAL

Period 1: Participants receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Drug: UpadacitinibDrug: Placebo to Adalimumab

Upadacitinib 30 mg

EXPERIMENTAL

Period 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Drug: UpadacitinibDrug: Placebo to Adalimumab

Adalimumab

ACTIVE COMPARATOR

Period 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks. Period 2: Participants continue to receive adalimumab 40 mg every other week.

Drug: AdalimumabDrug: Placebo to Upadacitinib

Placebo / Upadacitinib 15 mg

PLACEBO COMPARATOR

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Drug: UpadacitinibDrug: Placebo to UpadacitinibDrug: Placebo to Adalimumab

Placebo / Upadacitinib 30 mg

PLACEBO COMPARATOR

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Drug: UpadacitinibDrug: Placebo to UpadacitinibDrug: Placebo to Adalimumab

Interventions

Administered by subcutaneous injection

Also known as: Humira®
Adalimumab

Oral tablet

Also known as: ABT 494, RINVOQ®
Placebo / Upadacitinib 15 mgPlacebo / Upadacitinib 30 mgUpadacitinib 15 mgUpadacitinib 30 mg

Oral tablet

AdalimumabPlacebo / Upadacitinib 15 mgPlacebo / Upadacitinib 30 mg

Administered by subcutaneous injection

Placebo / Upadacitinib 15 mgPlacebo / Upadacitinib 30 mgUpadacitinib 15 mgUpadacitinib 30 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria.
  • Participant has active disease at Baseline defined as \>= 3 tender joints (based on 68 joint counts) and \>= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
  • Presence of either at Screening:
  • \>= 1 erosion on x-ray as determined by central imaging review or;
  • high-sensitivity C-reactive protein (hs-CRP) \> laboratory defined upper limit of normal (ULN).
  • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
  • Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.
  • Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on \<= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for \>= 12 weeks and at stable dose for \>= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.
  • \>= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);
  • \>= 4 weeks for all others.

You may not qualify if:

  • Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib).
  • Current treatment with \> 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
  • History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (345)

Rheum Assoc of North Alabama /ID# 163231

Huntsville, Alabama, 35801, United States

Location

SunValley Arthritis Center, Lt /ID# 161221

Peoria, Arizona, 85381, United States

Location

AZ Arthritis and Rheumotology Research, PLLC /ID# 159981

Phoenix, Arizona, 85032-9306, United States

Location

AZ Arthritis and Rheumotology Research, PLLC /ID# 160033

Phoenix, Arizona, 85032-9306, United States

Location

AZ Arthritis and Rheumotology Research, PLLC /ID# 160036

Phoenix, Arizona, 85032-9306, United States

Location

AZ Arthritis & Rheuma Research /ID# 160037

Phoenix, Arizona, 85032, United States

Location

AZ Arth & Rheum Res /ID# 166381

Tucson, Arizona, 85704, United States

Location

Little Rock Diagnostics Clinic /ID# 165161

Little Rock, Arkansas, 72205, United States

Location

Covina Arthritis Clinic /ID# 159891

Covina, California, 91722, United States

Location

St. Joseph Heritage Healthcare /ID# 159980

Fullerton, California, 92835, United States

Location

C.V. Mehta MD, Med Corporation /ID# 161216

Hemet, California, 92543, United States

Location

Care Access Research, Huntingt /ID# 160038

Huntington Beach, California, 92648, United States

Location

Kotha and Kotha /ID# 159823

La Mesa, California, 91942, United States

Location

TriWest Research Associates- La Mesa /ID# 159887

La Mesa, California, 91942, United States

Location

Arthritis & Osteo Medical Ctr /ID# 166760

La Palma, California, 90623-1728, United States

Location

University of California, Los Angeles /ID# 164542

Los Angeles, California, 90095, United States

Location

VA Sacramento Medical Center /ID# 164196

Mather, California, 95655, United States

Location

East Bay Rheumatology Medical /ID# 166382

San Leandro, California, 94578, United States

Location

Inland Rheum Clin Trials Inc. /ID# 159828

Upland, California, 91786, United States

Location

Medvin Clinical Research /ID# 160034

Whittier, California, 90606, United States

Location

Denver Arthritis Clinic /ID# 159873

Denver, Colorado, 80230, United States

Location

Arthritis and Rheum Clin N. CO /ID# 160039

Fort Collins, Colorado, 80528, United States

Location

Colorado Arthritis Associates /ID# 159847

Lakewood, Colorado, 80228, United States

Location

Stamford Therapeutics Consorti /ID# 165131

Stamford, Connecticut, 06905, United States

Location

Clinical Res of West FL, Inc. /ID# 159829

Clearwater, Florida, 33765, United States

Location

International Medical Research - Daytona /ID# 160040

Daytona Beach, Florida, 32117, United States

Location

Omega Research Maitland, LLC /ID# 164193

DeBary, Florida, 32713-2260, United States

Location

LeJenue Research Associates /ID# 170965

Miami, Florida, 33126, United States

Location

Precision Research Org, LLC /ID# 161287

Miami Lakes, Florida, 33016-1501, United States

Location

Medallion Clinical Research Institute, LLC /ID# 161228

Naples, Florida, 34102, United States

Location

Millennium Research /ID# 159822

Ormond Beach, Florida, 32174, United States

Location

Arthritis Center, Inc. /ID# 163465

Palm Harbor, Florida, 34684, United States

Location

Gulf Region Clinical Res Inst /ID# 159851

Pensacola, Florida, 32514, United States

Location

BayCare Medical Group /ID# 159792

St. Petersburg, Florida, 33705, United States

Location

W. Broward Rheum Assoc Inc. /ID# 161388

Tamarac, Florida, 33321, United States

Location

Clinical Research of West Florida, Inc /ID# 160063

Tampa, Florida, 33606-1246, United States

Location

University of South Florida /ID# 161286

Tampa, Florida, 33612, United States

Location

BayCare Medical Group, Inc. /ID# 159879

Tampa, Florida, 33614-7101, United States

Location

Florida Medical Clinic /ID# 159992

Zephyrhills, Florida, 33542, United States

Location

Institute of Arthritis Researc /ID# 165873

Idaho Falls, Idaho, 83404, United States

Location

Advanced Clinical Research /ID# 159894

Meridian, Idaho, 83642, United States

Location

Great Lakes Clinical Trials /ID# 163435

Chicago, Illinois, 60640, United States

Location

OrthoIllinois /ID# 164546

Rockford, Illinois, 61114-4937, United States

Location

Clinical Investigation Specialists - Skokie /ID# 160062

Skokie, Illinois, 60076, United States

Location

Deerbrook Medical Associates /ID# 159804

Vernon Hills, Illinois, 60061, United States

Location

Graves Gilbert Clinic /ID# 161285

Bowling Green, Kentucky, 42101, United States

Location

Four Rivers Clinical Research /ID# 159982

Paducah, Kentucky, 42001, United States

Location

Ochsner Clinic Foundation-New Orleans /ID# 165672

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins University /ID# 167665

Baltimore, Maryland, 21224, United States

Location

Klein & Associates, M.D., P.A. /ID# 164013

Cumberland, Maryland, 21502, United States

Location

The Center for Rheumatology & Bone Research /ID# 159874

Wheaton, Maryland, 20902, United States

Location

Tufts Medical Center /ID# 165144

Boston, Massachusetts, 02111, United States

Location

Mansfield Health Center /ID# 159805

Mansfield, Massachusetts, 02048, United States

Location

Clinical Pharmacology Study Gr /ID# 158700

Worcester, Massachusetts, 01605, United States

Location

Univ of Michigan Hospitals /ID# 164014

Ann Arbor, Michigan, 48109, United States

Location

Aa Mrc Llc /Id# 159846

Grand Blanc, Michigan, 48439, United States

Location

Advanced Rheumatology, PC /ID# 159893

Lansing, Michigan, 48910, United States

Location

Beals Institute PC /ID# 163128

Lansing, Michigan, 48917, United States

Location

Shores Rheumatology, PC /ID# 159889

Saint Clair Shores, Michigan, 48081, United States

Location

St. Luke's Hospital of Duluth /ID# 165671

Duluth, Minnesota, 55805, United States

Location

Clinvest Research LLC /ID# 161227

Springfield, Missouri, 65810-2607, United States

Location

Clayton Medical Associates dba Saint Louis Rheumatology /ID# 159878

St Louis, Missouri, 63119-3845, United States

Location

Glacier View Research Institut /ID# 167023

Kalispell, Montana, 59901, United States

Location

Westroads Clinical Research /ID# 159979

Omaha, Nebraska, 68114, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 161235

Lebanon, New Hampshire, 03756, United States

Location

Arthritis and Osteoporosis Associates /ID# 159802

Freehold, New Jersey, 07728, United States

Location

Atlantic Coast Research /ID# 159799

Toms River, New Jersey, 08755, United States

Location

Ocean Rheumatology, PA /ID# 163898

Toms River, New Jersey, 08755, United States

Location

Arthritis and Osteo Assoc /ID# 159994

Las Cruces, New Mexico, 88011, United States

Location

Santa Fe Rheumatology /ID# 163783

Santa Fe, New Mexico, 87505, United States

Location

NYU Langone Rheum Assoc /ID# 159985

Lake Success, New York, 11554, United States

Location

NYU Langone Medical Center /ID# 163230

New York, New York, 10016-6402, United States

Location

St. Lawrence Health System /ID# 159848

Potsdam, New York, 13676, United States

Location

American Health Research /ID# 164354

Charlotte, North Carolina, 28207, United States

Location

DJL Clinical Research, PLLC /ID# 161390

Charlotte, North Carolina, 28210-8508, United States

Location

M3-Emerging Medical Research, LLC /ID# 161391

Durham, North Carolina, 27704, United States

Location

Physicians East, PA /ID# 159872

Greenville, North Carolina, 27834, United States

Location

Cape Fear Arthritis Care /ID# 161224

Leland, North Carolina, 28451, United States

Location

Shanahan Rheuma & Immuno /ID# 159987

Raleigh, North Carolina, 27617, United States

Location

Trinity Health Med Arts Clinic /ID# 159800

Minot, North Dakota, 58701, United States

Location

MetroHealth Medical Center /ID# 159888

Cleveland, Ohio, 44109, United States

Location

The Ohio State University /ID# 159892

Columbus, Ohio, 43210, United States

Location

Clinical Research Source, Inc. /ID# 164545

Perrysburg, Ohio, 43551, United States

Location

STAT Research, Inc. /ID# 161392

Vandalia, Ohio, 45377-9464, United States

Location

Health Research of Oklahoma /ID# 159880

Oklahoma City, Oklahoma, 73103-2400, United States

Location

Altoona Ctr Clinical Res /ID# 159852

Duncansville, Pennsylvania, 16635, United States

Location

PA Regional Center /ID# 165670

Wyomissing, Pennsylvania, 19610, United States

Location

Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163464

Summerville, South Carolina, 29486-7887, United States

Location

West Tennessee Research Inst /ID# 159871

Jackson, Tennessee, 38305, United States

Location

Rheumatology Consultants, PLLC /ID# 159796

Knoxville, Tennessee, 37909, United States

Location

Dr. Ramesh Gupta /ID# 160061

Memphis, Tennessee, 38119, United States

Location

Accurate Clinical Management /ID# 159905

Baytown, Texas, 77521, United States

Location

Diagnostic Group Integrated He /ID# 159794

Beaumont, Texas, 77701, United States

Location

Arth and Osteo Clin Brazo Valley /ID# 163436

College Station, Texas, 77845, United States

Location

PCCR Solution /ID# 205723

Colleyville, Texas, 76034, United States

Location

Adriana Pop-Moody MD Clinic PA /ID# 159984

Corpus Christi, Texas, 78404, United States

Location

Metroplex Clinical Research /ID# 159785

Dallas, Texas, 75231, United States

Location

Rheumatic Disease Clin Res Ctr /ID# 161240

Houston, Texas, 77004, United States

Location

Rheumatology Clinic of Houston /ID# 161234

Houston, Texas, 77065, United States

Location

"DMCR-Texas Cent for Drug Dev /ID# 164191

Houston, Texas, 77081, United States

Location

West Texas Clinical Research /ID# 205722

Lubbock, Texas, 79410-1198, United States

Location

P&I Clinical Research /ID# 159826

Lufkin, Texas, 75904-3132, United States

Location

SW Rheumatology Res. LLC /ID# 159993

Mesquite, Texas, 75150, United States

Location

Trinity Universal Research Association /ID# 205721

Plano, Texas, 75024-5283, United States

Location

Arthritis & Osteo Ctr of S. TX /ID# 163784

San Antonio, Texas, 78232, United States

Location

Arthritis Clinic of Central TX /ID# 164049

San Marcos, Texas, 78666, United States

Location

DM Clinical Research /ID# 161735

Tomball, Texas, 77375, United States

Location

Arthritis & Osteoporosis Clinic /ID# 159786

Waco, Texas, 76710, United States

Location

Arthritis Clinic of N. VA, P.C /ID# 159849

Arlington, Virginia, 22205, United States

Location

Ctr for Arth and Rheum Disease /ID# 159830

Chesapeake, Virginia, 23320, United States

Location

Swedish Medical Center /ID# 159890

Seattle, Washington, 98104, United States

Location

Arthritis Northwest, PLLC /ID# 166380

Spokane, Washington, 99204, United States

Location

West Virginia Research Inst /ID# 159791

South Charleston, West Virginia, 25309, United States

Location

Aurora Rheumatology and Immunotherapy Center /ID# 160043

Franklin, Wisconsin, 53132, United States

Location

Centro Medico Privado/Reuma /ID# 159775

San Miguel de Tucumán, Ciuadad Autonoma de Buenos Aires, 4000, Argentina

Location

Centro Integral de Medicina Respiratoria (CIMER) /ID# 211237

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Organizacion Medica de Investigacion (OMI) /ID# 160118

Buenos Aires, 1015, Argentina

Location

Hospital General de Agudos Ram /ID# 164378

Buenos Aires, 1221, Argentina

Location

Psoriahue Med Interdisciplinar /ID# 160506

Buenos Aires, 1425, Argentina

Location

Inst. de Rehab. Psicofisica /ID# 165154

CABA, 1428, Argentina

Location

Instituto CAICI /ID# 160119

Rosario, Santa FE, 2000, Argentina

Location

Centro Integral de Medicina Re /ID# 160258

SAN Miguel de Tucuman, Latam, 4000, Argentina

Location

Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 165795

Santa Fe, 2000, Argentina

Location

Emeritus Research Sydney /ID# 166780

Botany, New South Wales, 2019, Australia

Location

The Queen Elizabeth Hospital /ID# 169333

Woodville, South Australia, 5011, Australia

Location

Barwon Rheumatology /ID# 166782

Geelong, Victoria, 3220, Australia

Location

Heidelberg Repatriation Hospital /ID# 167450

Heidelberg West, Victoria, 3081, Australia

Location

Brest Regional Hospital /ID# 164535

Brest, 224027, Belarus

Location

Healthcare Institution /ID# 164536

Grodno, 230017, Belarus

Location

First City Clinical Hospital /ID# 164534

Minsk, 220013, Belarus

Location

Reuma clinic /ID# 164243

Genk, 3600, Belgium

Location

University Clinical Centre of the Republic of Srpska /ID# 164503

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

University Clinical Hospital Mostar /ID# 165799

Mostar, 88000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo /ID# 164502

Sarajevo, 71000, Bosnia and Herzegovina

Location

Instituto de Ciencias Farmacêuticas /ID# 163274

Aparecida de Goiânia, Goiás, 74935-530, Brazil

Location

CIP - Centro Internacional de Pesquisa /ID# 161821

Goiânia, Goiás, 74110-120, Brazil

Location

CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 161819

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

EDUMED Educacao em Saude S/S L /ID# 161816

Curitiba, Paraná, 80440-080, Brazil

Location

Instituto de Educação e Pesquisa do Hospital Moinhos de Vento /ID# 161813

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital de Clinicas de Porto Alegre /ID# 161820

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

LMK Sevicos Medicos S/S /ID# 161812

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163273

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Faculdade de Medicina do ABC /ID# 163491

Santo André, São Paulo, 09060-870, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos do ABC /ID# 161810

Santo André, São Paulo, 09190-510, Brazil

Location

CPCLIN - Centro de Pesquisas Clínicas /ID# 161818

São Paulo, 01244-030, Brazil

Location

Department of Rheumatology, Mu /ID# 169606

Plovdiv, 4003, Bulgaria

Location

Excelsior Medical Center /ID# 169609

Sofia, 1407, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Sofia at Military Medical Academy /ID# 169608

Sofia, 1606, Bulgaria

Location

UMHAT Sv. Ivan Rilski /ID# 202393

Sofia, 1612, Bulgaria

Location

Medical Centre Synexus Sofia /ID# 202394

Sofia, 1784, Bulgaria

Location

Medical Centre Synexus Sofia, branch Stara Zagora /ID# 202524

Stara Zagora, 6000, Bulgaria

Location

Diagnostic Consultative Center /ID# 169607

Varna, 9000, Bulgaria

Location

Percuro Clinical Research, Ltd /ID# 157823

Victoria, British Columbia, V8V 3M9, Canada

Location

Manitoba Clinic /ID# 157829

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Ciads /Id# 157831

Winnipeg, Manitoba, R3N 0K6, Canada

Location

The Waterside Clinic /ID# 157826

Barrie, Ontario, L4M 6L2, Canada

Location

Groupe de Recherche en Maladies Osseuses Inc /ID# 157824

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

Ctr. de Recherche Musculo-Sque /ID# 207069

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

M y F Estudios Clínicos Ltda. /ID# 168722

Ñuñoa, Santiago Metropolitan, 7750495, Chile

Location

CTR Estudios SpA /ID# 206217

Providencia, 7500571, Chile

Location

Centro Inter Estud Clin CIEC /ID# 168725

Santiago, 8420383, Chile

Location

Prosalud Ltda. /ID# 169546

Santiago, ZC:7510047, Chile

Location

Clinica Dermacross S.A /ID# 168726

Vitacura Santiago, 7640881, Chile

Location

1st Aff Hosp of Bengbu Medical College /ID# 201021

Bengbu, Anhui, 233004, China

Location

Peking University Third Hospital /ID# 201973

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Shantou University Medical College /ID# 203371

Shantou, Guangdong, 515041, China

Location

Zhuzhou Central Hospital /ID# 200201

Zhuzhou, Hunan, 412007, China

Location

The First Affiliated Hospital of Baotou Medical College, Inner Monggolia Univers /ID# 171204

Baotou, Inner Mongolia, 014016, China

Location

The First People's Hospital of Linyi /ID# 201970

Linyi, Shandong, 276034, China

Location

Huashan Hospital of Fudan University /ID# 202191

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Changhai Hospital /ID# 200202

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital /ID# 200199

Chengdu, Sichuan, 610041, China

Location

Ningbo First Hospital /ID# 201874

Ningbo, Zhejiang, 315010, China

Location

The Aff Hosp Inner Mongolia /ID# 207787

Hohhot, 010050, China

Location

First Affiliated Hospital of Kunming Medical University /ID# 201264

Kunming, 650032, China

Location

Affiliated hospital of nantong university /ID# 208234

Nantong, 226001, China

Location

The First Affiliated Hospital of Soochow University /ID# 201875

Suzhou, 215006, China

Location

People's Hospital of Xinjiang /ID# 201592

Ürümqi, 830001, China

Location

Centro de Investigacion en Reumatologia CIREEM /ID# 166030

Bogota, Cundinamarca, 110231, Colombia

Location

Fundacion Centro de Investigac /Id# 168201

Antioquia, 050022, Colombia

Location

Ctr Int de Reum del Caribe SAS /ID# 164051

Barranquilla, 80002, Colombia

Location

Preventive Care Sas /Id# 163781

Chía, 250001, Colombia

Location

Hospital Pablo Tobon Uribe /ID# 164233

Medellín, Colombia

Location

Poliklinika Repromed /ID# 203555

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Rijeka /ID# 161159

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location

Medical Center Kuna-Peric /ID# 161160

Zagreb, 10000, Croatia

Location

Poliklinika Bonifarm /ID# 206662

Zagreb, 10000, Croatia

Location

Revmatologicka ambulance /ID# 159637

Prague, Praha 4, 140 00, Czechia

Location

Revmatologicka ambulance /ID# 159671

Prague, Praha 4, 140 00, Czechia

Location

Revmatologie Bruntal, s.r.o /ID# 159636

Bruntál, 79201, Czechia

Location

Artroscan s.r.o. /ID# 159634

Ostrava, 722 00, Czechia

Location

Medical Plus, s.r.o. /ID# 159635

Uherské Hradište, 686 01, Czechia

Location

Center of Clinical and Basic Research /ID# 163870

Tallinn, Harju, 10128, Estonia

Location

MediTrials /ID# 163706

Tartu, Tartu, 50406, Estonia

Location

East Tallinn Central Hospital /ID# 163790

Tallinn, 10138, Estonia

Location

Rheumazentrum Ruhrgebiet /ID# 163930

Herne, North Rhine-Westphalia, 44649, Germany

Location

Immanuel-Krankenhaus /ID# 163931

Buch, 13125, Germany

Location

University Clinic Carl Gustav /ID# 163926

Dresden, 01307, Germany

Location

Polikilinik fuer Rheumatologie /ID# 163933

Düsseldorf, 40225, Germany

Location

Cent fur Innovative Diagnostik /ID# 163927

Frankfurt, 60590, Germany

Location

Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 204421

Hamburg, 20095, Germany

Location

Dr. med. Jochen Walter FA fuer /ID# 168638

Rendsburg, 24768, Germany

Location

Med. Universitaetsklinik Inner /ID# 163929

Tübingen, 72076, Germany

Location

General Hospital of Athens Laiko /ID# 163476

Athens, Attica, 115 27, Greece

Location

General Hospital of Athens Laiko /ID# 163478

Athens, Attica, 115 27, Greece

Location

University General Hospital Attikon /ID# 163477

Athens, Attica, 12462, Greece

Location

Naval Hospital of Athens /ID# 163486

Athens, 11521, Greece

Location

University General Hospital of Heraklion PA.G.N.I /ID# 163472

Heraklion, 71110, Greece

Location

Reg Gen Univ Hosp Larissa /ID# 163496

Larissa, 41110, Greece

Location

Prince of Wales Hospital /ID# 163506

Hong Kong, 999077, Hong Kong

Location

Queen Mary Hospital /ID# 162492

Hong Kong, 999077, Hong Kong

Location

Tuen Mun Hospital /ID# 162493

Tuenmen, 999077, Hong Kong

Location

Synexus Magyarorszag Kft. - Gyula DRS /ID# 202209

Gyula, Bekes County, 5700, Hungary

Location

Qualiclinic Kft. /ID# 163278

Budapest III, Pest County, 1036, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatok.- Klinikai Kutatasi O. /ID# 202584

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Synexus Magyarorszag Kft. - Zalaegerszeg AS /ID# 201884

Zalaegerszeg, Zala County, 8900, Hungary

Location

Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170719

Budapest, 1023, Hungary

Location

Revita Reumatologiai Rendelo /ID# 163277

Budapest, 1027, Hungary

Location

Obudai Egeszsegugyi Centrum Kft. /ID# 163279

Budapest, 1036, Hungary

Location

Synexus Magyarorszag Kft. /ID# 203012

Budapest, 1036, Hungary

Location

Debreceni Egyetem Kenezy Gyula /ID# 163276

Debrecen, 4031, Hungary

Location

Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 163275

Veszprém, 8200, Hungary

Location

St Vincent's University Hosp /ID# 161073

Dublin, D04 T6F4, Ireland

Location

Croom Orthopaedic Hospital /ID# 164998

Limerick, V35 F434, Ireland

Location

Tel Aviv Sourasky Medical Center /ID# 169845

Tel Aviv, Tel Aviv, 6423906, Israel

Location

The Lady Davis Carmel MC /ID# 170262

Haifa, 3436212, Israel

Location

Sheba Medical Center /ID# 202532

Ramat Gan, 5239424, Israel

Location

AOU Federico II /ID# 202411

Naples, Campania, 80131, Italy

Location

Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 161090

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

Policlinico Universitario Campus Bio-Medico /ID# 162306

Rome, Lazio, 00128, Italy

Location

Ospedali Riuniti Universita /ID# 161085

Ancona, 60023, Italy

Location

Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 161084

Catania, 95123, Italy

Location

Nagoya City University Hospital /ID# 162564

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital /ID# 162086

Fukuoka, Fukuoka, 814-0180, Japan

Location

Hospital of the University of Occupational and Environmental Health /ID# 161473

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Mie University Hospital /ID# 162080

Tsu, Mie-ken, 514-8507, Japan

Location

National Hospital Organization Osaka Minami Medical Center /ID# 162590

Kawachinagano-shi, Osaka, 586-8521, Japan

Location

St.Luke's International Hospital /ID# 162016

Chuo-ku, Tokyo, 104-8560, Japan

Location

M &M Centrs /Id# 161483

Ādaži, LV2167, Latvia

Location

D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 161488

Liepāja, 3401, Latvia

Location

Clinic ORTO /ID# 161486

Riga, 1005, Latvia

Location

P. Stradins Clinical Univ Hosp /ID# 164442

Riga, LV-1002, Latvia

Location

VAKK dr. Kildos Clinic /ID# 167257

Kaunas, 50128, Lithuania

Location

Klaipeda University Hospital /ID# 167258

Klaipėda, 92288, Lithuania

Location

Public Institution Republican /ID# 165155

Šiauliai, 76231, Lithuania

Location

Vilnius University Hospital /ID# 165123

Vilnius, LT-08661, Lithuania

Location

Hospital Raja Permaisuri Bainun /ID# 161099

Ipoh, Perak, 30450, Malaysia

Location

Hospital Tuanku Ja afar /ID# 161096

Seremban, 70300, Malaysia

Location

Instituto Jalisciense de Metabolismo SC /ID# 164005

Guadalajara, Jalisco, 44670, Mexico

Location

CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 164006

Mexico City, Mexico City, 11850, Mexico

Location

Invest y Biomed de Chihuahua /ID# 164007

Chihuahua City, 31000, Mexico

Location

Medisch Centrum Leeuwarden /ID# 161575

Leeuwarden, 8934 AD, Netherlands

Location

Erasmus Medisch Centrum /ID# 161092

Rotterdam, 3015 CE, Netherlands

Location

Maasstad Ziekenhuis /ID# 160168

Rotterdam, 3079 DZ, Netherlands

Location

Waikato Hospital /ID# 166415

Hamilton, Waikato Region, 3204, New Zealand

Location

North Shore Hospital /ID# 169409

Auckland, 0622, New Zealand

Location

Middlemore Hospital /ID# 166414

Auckland, 2025, New Zealand

Location

Porter Rheumatology Ltd /ID# 200421

Nelson, 7010, New Zealand

Location

Timaru Rheumatology Studies /ID# 166413

Timaru, 7910, New Zealand

Location

Helse Forde /ID# 167853

Førde, Sogn Og Fjordane, 6812, Norway

Location

St. Olavs Hospital HF /ID# 163321

Trondheim, Sor-Trondelag, 7006, Norway

Location

NZOZ Nasz Lekarz /ID# 163774

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Malopolskie Centrum Kliniczne /ID# 163777

Krakow, Lesser Poland Voivodeship, 30-149, Poland

Location

Synexus Polska Sp. z o.o. /ID# 204506

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdansku /ID# 206299

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 207157

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

Synexus Polska Sp. z o.o. Oddzial Katowice /ID# 204510

Katowice, Silesian Voivodeship, 40-040, Poland

Location

ETYKA-Osrodek Badan Klinicznyc /ID# 163776

Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland

Location

Centrum Kliniczno-Badawcze /ID# 161830

Elblag, 82-300, Poland

Location

Krakowskie Centrum Medyczne /ID# 206302

Krakow, 31-501, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Poznaniu /ID# 207158

Poznan, 60-702, Poland

Location

Medycyna Kliniczna /ID# 166288

Warsaw, 00-874, Poland

Location

Synexus Polska Sp. z.o.o. /ID# 203987

Warsaw, 01-192, Poland

Location

Reumatika - Centrum Reumatologii NZOZ /ID# 161831

Warsaw, 02-691, Poland

Location

Salve Medica Sp. z o.o. S.K. /ID# 206300

Lodz, Łódź Voivodeship, 91-211, Poland

Location

Instituto Portugues De Reumatologia /ID# 165858

Lisbon, Lisbon District, 1050-034, Portugal

Location

Centro Hospitalar Lisboa Ocidental, EPE /ID# 165861

Lisbon, Lisbon District, 1349-019, Portugal

Location

Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165862

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Centro Hospitalar Lisboa Norte, EPE /ID# 165860

Lisbon, 1649-035, Portugal

Location

Hospital CUF Descobertas /ID# 165866

Lisbon, 1998-018, Portugal

Location

Hospital Beatriz Angelo /ID# 165865

Loures, 2674-514, Portugal

Location

Unidade Local De Saude Do Alto Minho /ID# 165863

Viana do Castelo, 4901-858, Portugal

Location

Cruz-Santana, Carolina, PR /ID# 163307

Carolina, 00985, Puerto Rico

Location

Ponce Medical School Foundation /ID# 163920

Ponce, 00716-0377, Puerto Rico

Location

GCM Medical Group, PSC /ID# 162160

San Juan, 00917, Puerto Rico

Location

Family Outpatient clinic#4 LLC /ID# 164530

Korolev, Moscow, 141060, Russia

Location

LLC Medical Center /ID# 164529

Novosibirsk, Novosibirsk Oblast, 630099, Russia

Location

Kazan State Medical University /ID# 164531

Kazan', Tatarstan, Respublika, 420012, Russia

Location

Moscow S.P.Botkin City Clinica /ID# 164533

Moscow, 125284, Russia

Location

State budgetary institution /ID# 164532

Saint Petersburg, 192242, Russia

Location

Institute for Rheumatology /ID# 166217

Belgrade, Beograd, 11000, Serbia

Location

Institute for Rheumatology /ID# 166223

Belgrade, Beograd, 11000, Serbia

Location

Institute for Rheumatology /ID# 166229

Belgrade, Beograd, 11000, Serbia

Location

Institute for Rheumatology /ID# 166231

Belgrade, Beograd, 11000, Serbia

Location

Military Medical Academy /ID# 166293

Belgrade, Beograd, 11000, Serbia

Location

Singapore General Hospital /ID# 161094

Singapore, Central Singapore, 169068, Singapore

Location

Tan Tock Seng Hospital /ID# 161095

Singapore, 308433, Singapore

Location

MEDMAN s.r.o. /ID# 165892

Martin, 036 01, Slovakia

Location

Reumatologická ambulancia Reum.hapi s.r.o. /ID# 166486

Nové Mesto nad Váhom, 915 01, Slovakia

Location

Slovak research center Team Member, Thermium s.r.o. /ID# 166489

Pieštany, 921 01, Slovakia

Location

Univ Medical Ctr Ljubljana /ID# 164212

Ljubljana, 1000, Slovenia

Location

University Medical Ctr Maribor /ID# 169260

Maribor, 2000, Slovenia

Location

General Hospital Murska Sobota /ID# 164211

Murska Sobota, 9000, Slovenia

Location

Greenacres Hospital /ID# 164190

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Wits Clinical Research Site /ID# 163919

Johannesburg, Gauteng, 2193, South Africa

Location

University of Pretoria /ID# 163852

Pretoria, Gauteng, 0001, South Africa

Location

Jakaranda Hospital /ID# 164242

Pretoria, Gauteng, 0002, South Africa

Location

Arthritis Clinical Research Tr /ID# 163855

Cape Town, Western Cape, 7405, South Africa

Location

Winelands Medical Research Ctr /ID# 163853

Stellenbosch, Western Cape, 7600, South Africa

Location

Ajou University Hospital /ID# 163891

Suwon, Gyeonggido, 16499, South Korea

Location

Inha University Hospital /ID# 163890

Junggu, Incheon Gwang Yeogsi, 22332, South Korea

Location

Hospital Universitario A Coruña - CHUAC /ID# 161129

A Coruña, A Coruna, 15006, Spain

Location

Hospital Campus de la Salud /ID# 170760

Granada, 18016, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 161130

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre /ID# 163198

Madrid, 28041, Spain

Location

Kantonsspital St. Gallen /ID# 158131

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

HFR Fribourg - Hopital Canton /ID# 162090

Fribourg, 1708, Switzerland

Location

China Medical University Hosp /ID# 159402

Taichung, Taichung, 40447, Taiwan

Location

Chung Shan Medical University /ID# 159403

Taichung, 404, Taiwan

Location

National Taiwan University Hospital /ID# 160878

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hosp /ID# 166222

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Ho /ID# 166221

Taoyuan, 33305, Taiwan

Location

Cukurova Universitesi Tip Fakultesi /ID# 162516

Saricam Adana, Adana, 01330, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fak /ID# 162518

Sihhiye, Ankara, 06100, Turkey (Türkiye)

Location

Bakirkoy Dr. Sadi Konuk Training & Research Hospital /ID# 162517

Istanbul, 34147, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 163383

Istanbul, 34899, Turkey (Türkiye)

Location

Necmettin Erbakan Universitesi /ID# 163382

Meram Konya, 42080, Turkey (Türkiye)

Location

Sakarya Universitesi Egitim /ID# 163397

Sakarya, 54100, Turkey (Türkiye)

Location

State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 164170

Kharkiv, Kharkivs’ka Oblast’, 61039, Ukraine

Location

Lviv Regional Clinical Hospita /ID# 164178

Lviv, Lviv Oblast, 79013, Ukraine

Location

Kharkiv Regional Council Regional Clinical Hospital /ID# 210189

Kharkiv, 61058, Ukraine

Location

NSC Strazhesko Ist Cardiology /ID# 164043

Kiev, 03680, Ukraine

Location

Med Ctr of Private High Ed Ins /ID# 208527

Kyiv, 02002, Ukraine

Location

Medical Center of LLC Medbud-Clinic /ID# 208528

Kyiv, 03037, Ukraine

Location

Kyiv Railway Clinical Hosp No.2 /ID# 208951

Kyiv, 03049, Ukraine

Location

LLC Revmocentr /ID# 164177

Kyiv, 04070, Ukraine

Location

MNI KRC Kyiv Regional Clinical Hospital /ID# 210188

Kyiv, 04107, Ukraine

Location

Odessa National Medical Univ /ID# 164244

Odesa, 65026, Ukraine

Location

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 164245

Vinnytsia, 21018, Ukraine

Location

Whipps Cross Univ Hospital /ID# 161055

London, London, City of, E11 1NR, United Kingdom

Location

Guy's and St Thomas' NHS Found /ID# 161065

London, London, City of, SE1 9RT, United Kingdom

Location

Christchurch Hospital /ID# 162702

Christchurch, BH23 2JX, United Kingdom

Location

UH Coventry & Warwickshire /ID# 162701

Coventry, CV2 2DX, United Kingdom

Location

Glasgow Royal Infirmary /ID# 162703

Glasgow, G4 0SF, United Kingdom

Location

Luton & Dunstable University Hospital /ID# 162704

Luton, LU4 0DZ, United Kingdom

Location

Related Publications (14)

  • Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.

  • Burmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.

  • Cantini F, Marchesoni A, Novelli L, Gualberti G, Marando F, McDearmon-Blondell EL, Gao T, McGonagle D, Salvarani C. Effects of upadacitinib on enthesitis in patients with psoriatic arthritis: a post hoc analysis of SELECT-PsA 1 and 2 trials. Rheumatology (Oxford). 2024 Nov 1;63(11):3146-3154. doi: 10.1093/rheumatology/keae057.

  • Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.

  • Charles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.

  • Baraliakos X, Ranza R, Ostor A, Ciccia F, Coates LC, Rednic S, Walsh JA, Douglas K, Gao T, Kato K, Song IH, Ganz F, Deodhar A. Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies. Arthritis Res Ther. 2023 Apr 10;25(1):56. doi: 10.1186/s13075-023-03027-5.

  • Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.

  • McInnes IB, Kato K, Magrey M, Merola JF, Kishimoto M, Haaland D, Chen L, Duan Y, Liu J, Lippe R, Wung P. Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study. Rheumatol Ther. 2023 Feb;10(1):275-292. doi: 10.1007/s40744-022-00499-w. Epub 2022 Oct 15.

  • Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.

  • Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.

  • Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.

  • Strand V, Mease PJ, Soriano ER, Kishimoto M, Salvarani C, Saffore CD, Zueger P, McDearmon-Blondell E, Kato K, Gladman DD. Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. Rheumatol Ther. 2021 Dec;8(4):1789-1808. doi: 10.1007/s40744-021-00379-9. Epub 2021 Oct 12.

  • Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.

  • McInnes IB, Anderson JK, Magrey M, Merola JF, Liu Y, Kishimoto M, Jeka S, Pacheco-Tena C, Wang X, Chen L, Zueger P, Liu J, Pangan AL, Behrens F. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. N Engl J Med. 2021 Apr 1;384(13):1227-1239. doi: 10.1056/NEJMoa2022516.

Related Links

MeSH Terms

Conditions

Arthritis, PsoriaticArthritisPsoriasisJoint DiseasesMusculoskeletal Diseases

Interventions

Adalimumabupadacitinib

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 7, 2017

Study Start

April 27, 2017

Primary Completion

September 26, 2019

Study Completion

September 9, 2024

Last Updated

September 22, 2025

Results First Posted

January 25, 2022

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
More information

Locations