Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
SELECT-SLE
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
2 other identifiers
interventional
1,014
37 countries
365
Brief Summary
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2023
Typical duration for phase_3
365 active sites
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 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 28, 2026
April 1, 2026
3.6 years
April 25, 2023
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
At Week 52
Secondary Outcomes (10)
Percentage of Flares Participants Experiencing Over Time.
Week 52
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4
At Week 52
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)
At Week 52
Time to First Flare per SELENA SLEDAI Flare Index (SFI)
Week 52
Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent
From Week 44 to Week 52
- +5 more secondary outcomes
Study Arms (12)
Study 1- Upadacitinib Dose A
EXPERIMENTALParticipants will receive upadacitinib dose A once daily for 52 weeks.
Study 1- Placebo
PLACEBO COMPARATORParticipants will receive upadacitinib matching placebo once daily for 52 weeks.
Study 2- Upadacitinib Dose A
EXPERIMENTALParticipants will receive upadacitinib dose A once daily for 52 weeks.
Study 2- Placebo
PLACEBO COMPARATORParticipants will receive upadacitinib matching placebo once daily for 52 weeks.
Study 3- Low Disease Activity Upadacitinib (LDA) Dose A
EXPERIMENTALParticipants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Study 3- Low Disease Activity Upadacitinib Dose B
EXPERIMENTALParticipants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Study 3- No LDA Upadacitinib Dose A
EXPERIMENTALParticipants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Study 3- Upadacitininb Dose A
EXPERIMENTALParticipants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Study 3- Open Label Upadacitinib Dose A
EXPERIMENTALParticipants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
Study 3- Open Label Upadacitinib Dose B
EXPERIMENTALParticipants who reach \>= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.
Study 4- Upadacitinib Dose A
EXPERIMENTALParticipants receiving upadacitinib Dose A in Study 3 will continue on this dose once daily for 104 weeks.
Study 4- Upadacitinib Dose B
EXPERIMENTALParticipants receiving upadacitinib Dose B in Study 3 will continue on this dose once daily for 104 weeks.
Interventions
Oral Tablets
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
- At Screening, must have at least one of the following:
- antinuclear antibody (ANA) positive (titer \>= 1:80)
- anti-double stranded deoxyribonucleic acid (dsDNA) positive
- anti-Smith positive
- Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) \>= 6, of which \>= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as \>= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
- Physician's Global Assessment (PhGA) \>= 1 during screening period.
- On stable background treatment for \>= 60 days prior to Baseline (with the exception of oral corticosteroid \[OCS\], which must be at a stable dose for \>=14 days prior to Baseline) with
- antimalarial(s) \[hydroxychloroquine \<= 400 mg daily, chloroquine \<= 500 mg daily, quinacrine \<= 100 mg daily\];
- and/or prednisone (or prednisone-equivalent) (\<= 20 mg daily);
- and/or no more than 1 of the following: azathioprine (\<= 150 mg daily), 6-mercaptopurine (\<= 150 mg daily), mycophenolate mofetil (\<= 2 g daily), mycophenolate sodium \<= 1,440 mg/day, leflunomide (\<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (\<= 23.7 mg twice daily), methotrexate (\<= 25 mg weekly), or mizoribine (\<= 150 mg daily).
You may not qualify if:
- Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
- Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
- SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
- Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
- Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
- History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
- Pregnancy, breastfeeding, or considering becoming pregnant during the study.
- Clinically relevant or significant ECG abnormalities at Screening.
- Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (369)
AZ Arthritis and Rheumatology /ID# 261848
Chandler, Arizona, 85225-2906, United States
AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
Flagstaff, Arizona, 86001-6299, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
Gilbert, Arizona, 85297-7336, United States
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
Glendale, Arizona, 85306-9802, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845
Mesa, Arizona, 85210-6871, United States
Arizona Arthritis & Rheumatology Research /ID# 273555
Peoria, Arizona, 85381, United States
Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831
Phoenix, Arizona, 85032, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825
Phoenix, Arizona, 85037, United States
HonorHealth Rheumatology /ID# 261953
Scottsdale, Arizona, 85258-4668, United States
Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828
Tucson, Arizona, 85704, United States
Arthritis and Rheumatism Associates /ID# 253033
Jonesboro, Arkansas, 72401-6251, United States
Kaiser Permanente Lakeview Medical Offices /ID# 253906
Anaheim, California, 92807-3028, United States
David S. Hallegua MD, A Professional Corporation /ID# 253902
Beverly Hills, California, 90211, United States
Wallace and Lee Center /ID# 275129
Beverly Hills, California, 90211, United States
Wallace Rheumatic Studies Center, LLC /ID# 252806
Beverly Hills, California, 90211, United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870
Chula Vista, California, 91910, United States
Providence - St. Jude Medical Center /ID# 252822
Fullerton, California, 92835, United States
Private Practice - Dr. Chandrakant V. Mehta /ID# 275100
Hemet, California, 92543, United States
Newport Huntington Medical Group /ID# 252827
Huntington Beach, California, 92648-5994, United States
Moores Cancer Center at UC San Diego /ID# 253903
La Jolla, California, 92093, United States
Arthritis & Osteo Medical Ctr /ID# 252812
La Palma, California, 90623-1728, United States
Wagdy Kades, M.D., Inc /ID# 272065
Los Angeles, California, 90017, United States
Providence St. Johns Health Center /ID# 253905
Santa Monica, California, 90404-2303, United States
Millennium Clinical Trials /ID# 252817
Thousand Oaks, California, 91360-3951, United States
Cohen Medical Centers /ID# 268524
Thousand Oaks, California, 91360, United States
Solace Research /ID# 275198
Tustin, California, 92780, United States
Upland Rheumatology Center /ID# 268623
Upland, California, 91786, United States
University of Colorado Hospital /ID# 253184
Aurora, Colorado, 80045, United States
Denver Arthritis Clinic /ID# 253189
Denver, Colorado, 80230, United States
Yale University School of Medicine /ID# 254567
New Haven, Connecticut, 06510, United States
Arthritis and Rheumatic Disease Specialties /ID# 253624
Aventura, Florida, 33180, United States
HARAC Research Corp. /ID# 254922
Avon Park, Florida, 33825-2958, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623
Boca Raton, Florida, 33486, United States
Mdr Core Network, Inc /Id# 276704
Boynton Beach, Florida, 33426, United States
Bay Area Arthritis and Osteo /ID# 253597
Brandon, Florida, 33511, United States
GNP Consultants, dba, GNP Research /ID# 272868
Cooper City, Florida, 33024, United States
Duplicate_Believe Clinical Trials /ID# 255427
Coral Springs, Florida, 33065, United States
International Medical Research /ID# 253617
Daytona Beach, Florida, 32117, United States
Omega Research Debary, LLC /ID# 254939
DeBary, Florida, 32713-2260, United States
University of Florida /ID# 261984
Gainesville, Florida, 32610-3008, United States
Finlay Medical Research - Greenacres /ID# 274902
Greenacres City, Florida, 33467, United States
Evolution Research Center /ID# 272991
Hialeah, Florida, 33012, United States
Neoclinical Research /ID# 253614
Hialeah, Florida, 33016-1897, United States
South Florida Rheumatology /ID# 268525
Hollywood, Florida, 33026, United States
Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272
Jacksonville, Florida, 32216, United States
UF Health Rheumatology /ID# 255351
Jacksonville, Florida, 32256, United States
Life Clinical Trials /ID# 253615
Margate, Florida, 33063, United States
Lakes Research, LLC /ID# 253621
Miami, Florida, 33014, United States
University of Miami, Division of Rheumatology /ID# 261594
Miami, Florida, 33136-2107, United States
Ezy Medical Research /ID# 276221
Miami, Florida, 33175, United States
HMD Research LLC /ID# 253595
Orlando, Florida, 32819, United States
University of Central Florida /ID# 261112
Orlando, Florida, 32827-7664, United States
Millennium Research /ID# 253600
Ormond Beach, Florida, 32174, United States
Vitalia Research /ID# 272642
Palm Beach Gardens, Florida, 33410, United States
Believe Clinical Trials /ID# 277004
Plant City, Florida, 33563, United States
IRIS Research and Development, LLC /ID# 253618
Plantation, Florida, 33324, United States
BayCare Medical Group /ID# 253593
St. Petersburg, Florida, 33705, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253602
Tampa, Florida, 33606, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253899
Tampa, Florida, 33606, United States
Baycare Medical Group - Tampa /ID# 255135
Tampa, Florida, 33614, United States
Emory University School Of Medicine - Atlanta /ID# 261529
Atlanta, Georgia, 30322, United States
Trinity Research Centers /ID# 262039
Kennesaw, Georgia, 30144-1762, United States
Atlanta Research Center For Rheumatology - Marietta /ID# 253610
Marietta, Georgia, 30060, United States
Arthritis and Rheumatology Center PC /ID# 275994
Roswell, Georgia, 30076, United States
Immunology and Rheumatology Research Associates LLC /ID# 267582
Suwanee, Georgia, 30024-7290, United States
University of Illinois Hospital and Health Sciences System /ID# 263014
Chicago, Illinois, 60607, United States
Northwestern University Feinberg School of Medicine /ID# 264090
Chicago, Illinois, 60611-2927, United States
Next Innovative Clinical Research - Chicago /ID# 268739
Chicago, Illinois, 60616, United States
University of Chicago Medical Center /ID# 263162
Chicago, Illinois, 60637, United States
Illinois Bone & Joint Institute - Morton /ID# 274455
Morton, Illinois, 60053, United States
Advanced Quality Medical Research /ID# 254983
Orland Park, Illinois, 60462, United States
OrthoIllinois /ID# 253188
Rockford, Illinois, 61114-4937, United States
Greater Chicago Specialty Physicians /ID# 253021
Schaumburg, Illinois, 60195-3106, United States
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020
Skokie, Illinois, 60076, United States
NorthShore University HealthSystem - Skokie /ID# 254568
Skokie, Illinois, 60077, United States
Deerbrook Medical Associates /ID# 253029
Vernon Hills, Illinois, 60061, United States
Willow Rheumatology and Wellness, PLLC /ID# 253018
Willowbrook, Illinois, 60527, United States
Western KY Rheumatology /ID# 254937
Hopkinsville, Kentucky, 42240, United States
Accurate Clinical Research (SMO/Network/Consortium) /ID# 272647
Lake Charles, Louisiana, 70605, United States
Willis Knighton /ID# 256343
Shreveport, Louisiana, 71103-3920, United States
University of Maryland, Baltimore /ID# 262556
Baltimore, Maryland, 21201, United States
UMass Memorial Medical Center /ID# 262742
Worcester, Massachusetts, 01655, United States
Clinical Research Institute Of Michigan /ID# 273051
Clinton Township, Michigan, 48038, United States
AA Medical Research Center - Grand Blanc /ID# 253028
Grand Blanc, Michigan, 48439, United States
June DO, PC /ID# 253030
Lansing, Michigan, 48911, United States
Kansas City Physician Partners /ID# 254786
Kansas City, Missouri, 64151, United States
Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 252808
Kalispell, Montana, 59901, United States
Dartmouth-Hitchcock Medical Center /ID# 254923
Lebanon, New Hampshire, 03756, United States
Arthritis and Osteoporosis Associates of New Mexico /ID# 252818
Las Cruces, New Mexico, 88011, United States
Inspire Santa Fe Medical Group /ID# 275947
Santa Fe, New Mexico, 87505, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592
Brooklyn, New York, 11201-5501, United States
NYU Langone Orthopedic Center /ID# 253613
New York, New York, 10016-2772, United States
St. Lawrence Health System /ID# 253598
Potsdam, New York, 13676, United States
Urban Health Plan /ID# 268059
The Bronx, New York, 10459, United States
Joint And Muscle Research Institute /ID# 272845
Charlotte, North Carolina, 28204, United States
DJL Clinical Research, PLLC /ID# 253620
Charlotte, North Carolina, 28211, United States
Raleigh Medical Group /ID# 256328
Raleigh, North Carolina, 27609, United States
Accellacare - Salisbury /ID# 253608
Salisbury, North Carolina, 28144-2735, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 254125
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center /ID# 259174
Cincinnati, Ohio, 45219-2364, United States
Paramount Medical Research and Consulting /ID# 253016
Middleburg Heights, Ohio, 44130, United States
Clinical Research Source, Inc. /ID# 253027
Perrysburg, Ohio, 43551, United States
Oklahoma Medical Research Foundation /ID# 263509
Oklahoma City, Oklahoma, 73104, United States
Rheumatology Associates of Oklahoma /ID# 253012
Oklahoma City, Oklahoma, 73116-7226, United States
Clinical Research of Philadelphia, LLC /ID# 254156
Philadelphia, Pennsylvania, 19114, United States
Albert Einstein Medical Center /ID# 256661
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Medical Center /ID# 263686
Pittsburgh, Pennsylvania, 15213, United States
Low Country Rheumatology /ID# 272956
Summerville, South Carolina, 29486, United States
West Tennessee Research Institute /ID# 252807
Jackson, Tennessee, 38305, United States
Shelby Research /ID# 256937
Memphis, Tennessee, 38119, United States
Arthritis and Rheumatology Research Institute, PLLC /ID# 253014
Allen, Texas, 75013-6147, United States
Rheumatology Associates /ID# 276066
Arlington, Texas, 76012, United States
Arthritis Care of Texas /ID# 261719
Corpus Christi, Texas, 78415-1800, United States
Texas Arthritis Center /ID# 277049
El Paso, Texas, 79902, United States
JPS Rheumatology Clinic /ID# 253185
Fort Worth, Texas, 76104-4917, United States
Arthiritis and Rheumatology Specialists PA /ID# 255950
Fort Worth, Texas, 76177, United States
Integrative Rheumatology of South Texas - Harlingen /ID# 261977
Harlingen, Texas, 78550, United States
Accurate Clinical Research - Houston /ID# 276220
Houston, Texas, 77089-6142, United States
Accurate Clinical Research Katy /ID# 276459
Katy, Texas, 77449, United States
R & H Clinical Research - Katy /ID# 254126
Katy, Texas, 77450-2244, United States
Biopharma Informatic /ID# 273651
Katy, Texas, 77494, United States
Valley Arthritis Center /ID# 253022
McAllen, Texas, 78501-1401, United States
Texas Rheumatology Research Institute Llc /Id# 253013
Plano, Texas, 75024, United States
Epic Medical Research /ID# 255326
Red Oak, Texas, 75154, United States
Sun Research Institute /ID# 255832
San Antonio, Texas, 78215, United States
Clinical Trials of Texas, Inc /ID# 254949
San Antonio, Texas, 78229, United States
Epic Medical Research- San Marcos /ID# 278360
San Marcos, Texas, 78666, United States
Fort Bend Rheumatology Associates, PLLC /ID# 268492
Sugar Land, Texas, 77479, United States
DM Clinical Research - Tomball /ID# 255134
Tomball, Texas, 77375, United States
Carilion Roanoke Memorial Hospital /ID# 253374
Roanoke, Virginia, 24014, United States
Rheumatology & Pulmonary Clinic /ID# 273561
Beckley, West Virginia, 25801, United States
Wisconsin Medical Center /ID# 256660
Milwaukee, Wisconsin, 53226, United States
Fundación Sanatorio Guemes /ID# 254283
Ciudad Autonoma Buenos Aires, Buenos Aires, 1180, Argentina
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 254278
Ciudad Autonoma Buenos Aires, Buenos Aires, 1426, Argentina
Hospital Italiano La Plata /ID# 254284
La Plata, Buenos Aires, 1900, Argentina
CER Instituto Medico /ID# 255302
Quilmes, Buenos Aires, 1878, Argentina
Organizacion Medica de Investigacion (OMI) /ID# 254281
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1015, Argentina
Fundacion CIDEA /ID# 254279
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1121, Argentina
Instituto Medico Especializado /ID# 255281
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1405, Argentina
Aprillus Asistencia e Investigacion /ID# 254276
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1958, Argentina
Instituto CAICI S.R.L /ID# 254280
Rosario, Santa Fe Province, 2000, Argentina
Centro de Investigaciones Medicas Tucuman /ID# 254274
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Emeritus Research Sydney /ID# 256249
Botany, New South Wales, 2019, Australia
Concord Repatriation General Hospital /ID# 257945
Concord, New South Wales, 2139, Australia
Momentum Clinical Research /ID# 253542
Darlinghurst, New South Wales, 2010, Australia
Royal Darwin Hospital /ID# 263160
Tiwi, Northern Territory, 0811, Australia
The Queen Elizabeth Hospital /ID# 253826
Woodville, South Australia, 5011, Australia
Emeritus Research /ID# 256800
Camberwell, Victoria, 3124, Australia
Monash Health - Monash Medical Centre /ID# 255678
Clayton, Victoria, 3168, Australia
Colin Bayliss Research and Teaching Unit /ID# 261077
Victoria Park, Western Australia, 6100, Australia
ZAS Palfijn /ID# 252802
Merksem, Antwerpen, 2170, Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 261997
Anderlecht, Brussels Capital, 1070, Belgium
Universitair Ziekenhuis Brussel /ID# 269065
Jette, Brussels Capital, 1090, Belgium
Institute of Physical Medicine,Rehab. and Orthopedic Surgery Dr.Miroslav Zotovic /ID# 262588
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 253581
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 253582
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 253583
Sarajevo, 71000, Bosnia and Herzegovina
Polyclinic Srce Sarajeva /ID# 255475
Sarajevo, 71210, Bosnia and Herzegovina
CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo /ID# 254588
Vitória, Espírito Santo, 29055-450, Brazil
SER - Servicos Especializados em Reumatologia da Bahia /ID# 253354
Salvador, Estado de Bahia, 40150-150, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 253346
Juiz de Fora, Minas Gerais, 36010-570, Brazil
Nossa Saude Pesquisa Ltda. /ID# 253274
Curitiba, Paraná, 80440-210, Brazil
Hospital de Clinicas de Porto Alegre /ID# 253357
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
LMK Sevicos Medicos S/S /ID# 253353
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 261024
São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital do Rim /ID# 253983
São Paulo, 04038-002, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254316
São Paulo, 05403-000, Brazil
Mc Excelsior /ID# 272499
Sofiya, Sofia, 1407, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252642
Sofiya, Sofia, 1463, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252643
Sofiya, Sofia, 1463, Bulgaria
Umbal Kaspela /ID# 252645
Plovdiv, 4001, Bulgaria
Medical Center Artmed Ltd /Id# 254572
Plovdiv, 4002, Bulgaria
Medical center Unimed /ID# 253324
Plovdiv, 4023, Bulgaria
Medical center Teodora /ID# 252646
Rousse, 7012, Bulgaria
Military Medical Academy Multiprofile Hospital /ID# 252644
Sofia, 1606, Bulgaria
Medical Center Academy /ID# 253322
Sofia, 1612, Bulgaria
University of Calgary /ID# 259515
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital /ID# 259516
Edmonton, Alberta, T6G 2B7, Canada
University of Manitoba /ID# 259517
Winnipeg, Manitoba, R3A 1M4, Canada
Toronto Western Hospital /ID# 254017
Toronto, Ontario, M5T 2S8, Canada
CIUSSS de l'Estrie - CHUS /ID# 254716
Sherbrooke, Quebec, J1G 2E8, Canada
Servicio de Salud Araucanía Norte Hospital Victoria /ID# 255179
Victoria, Araucania, 4720000, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 254841
Concepción, Biobio, 4070038, Chile
Centro Internacional de Estudios Clinicos - CIEC /ID# 254838
Santiago, Region Metropolitana Santiago, 8420383, Chile
Inmunocel /Id# 256390
Las Condes, Santiago Metropolitan, 7580206, Chile
Investigaciones Medicas Limitada /Id# 254842
Providencia, 7500710, Chile
The first affiliated hospital of bengbu medical college /ID# 252853
Bengbu, Anhui, 233004, China
China-Japan Friendship Hospital /ID# 253048
Beijing, Beijing Municipality, 100029, China
Peking University Third Hospital /ID# 253138
Beijing, Beijing Municipality, 100191, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 253045
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Xiamen University /ID# 252630
Xiamen, Fujian, 361003, China
Guangdong Provincial Peoples Hospital /ID# 252920
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital, Sun Yat-sen University /ID# 252921
Guangzhou, Guangdong, 510080, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 253137
Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital Of Guangzhou Medical University /ID# 252927
Guangzhou, Guangdong, 510163, China
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252923
Guangzhou, Guangdong, 510630, China
The First Affiliated Hospital of Shantou University Medical College /ID# 253426
Shantou, Guangdong, 515041, China
The First Affiliated Hospital Of Guangxi Medical University /ID# 272798
Nanning, Guangxi, 530021, China
The First Affiliated Hospital Of Henan University Of Science &Technology /ID# 272929
Luoyang, Henan, 471003, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 252963
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College of HUST /ID# 252632
Wuhan, Hubei, 430030, China
Zhuzhou Central Hospital /ID# 252962
Zhuzhou, Hunan, 412007, China
The Affiliated Hospital of Inner Mongolia Medical University /ID# 252629
Hohhot, Inner Mongolia, 010050, China
The First People's Hospital of Changzhou /ID# 252992
Changzhou, Jiangsu, 213003, China
Nanjing Drum Tower Hospital /ID# 253042
Nanjing, Jiangsu, 210008, China
Affiliated hospital of nantong university /ID# 252991
Nantong, Jiangsu, 226001, China
Wuxi People's Hospital /ID# 253858
Wuxi, Jiangsu, 214023, China
Xuzhou Central Hospital /ID# 252922
Xuzhou, Jiangsu, 221009, China
Yancheng First People's Hospital /ID# 254599
Yancheng, Jiangsu, 224001, China
Northern Jiangsu People's Hospital /ID# 252945
Yangzhou, Jiangsu, 225001, China
The First People's Hospital of Jiujiang /ID# 252989
Jiujiang, Jiangxi, 332000, China
Jiangxi Provincial People's Hospital /ID# 252940
Nanchang, Jiangxi, 330006, China
Jiangxi Pingxiang Peoples Hospital /ID# 252919
Pingxiang, Jiangxi, 337055, China
The First Hospital of Jilin University /ID# 252771
Changchun, Jilin, 130021, China
Second Affiliated Hospital of Xian Jiaotong University /ID# 252861
Xi'an, Shaanxi, 710004, China
Jining No.1 People's Hospital /ID# 252897
Jining, Shandong, 272001, China
Linyi People's Hospital /ID# 252898
Linyi, Shandong, 276034, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 263435
Shanghai, Shanghai Municipality, 200001, China
West China Hospital, Sichuan University /ID# 252854
Chengdu, Sichuan, 610041, China
Mianyang Central Hospital /ID# 272850
Mianyang, Sichuan, 621000, China
Tianjin Medical University General Hospital /ID# 252868
Tianjin, Tianjin Municipality, 300052, China
People's Hospital of Xinjiang Uygur Autonomous Region /ID# 266897
Ürümqi, Xinjiang, 830001, China
First Affiliated Hospital of Kunming Medical University /ID# 252925
Kunming, Yunnan, 650032, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 252633
Hangzhou, Zhejiang, 310003, China
Zhejiang Provincial People's Hospital /ID# 253860
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 253649
Wenzhou, Zhejiang, 325000, China
IPS Suramericana SAS - IPS Sura San Diego /ID# 261536
Medellín, Antioquia, 050016, Colombia
Hospital Pablo Tobón Uribe /ID# 254101
Medellín, Antioquia, 050034, Colombia
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254097
Bogotá, Cundinamarca, 110221, Colombia
Healthy Medical Center S.A.S /ID# 254098
Zipaquirá, Cundinamarca, 250252, Colombia
Fundacion Oftalmologica de Santander - FOSCAL /ID# 254100
Bucaramanga, Santander Department, 681004, Colombia
Clinica de la Costa S.A.S /ID# 260727
Barranquilla, 080020, Colombia
Poliklinika Bonifarm /ID# 252846
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 252965
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Osijek /ID# 252847
Osijek, County of Osijek-Baranja, 31000, Croatia
Klinicki bolnicki centar Rijeka /ID# 252848
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 252849
Split, Split-Dalmatia County, 21000, Croatia
Opća Bolnica Zadar /ID# 272415
Zadar, Zadar County, 23000, Croatia
Innomedica /ID# 253722
Tallinn, Harju, 10117, Estonia
East Tallinn Central Hospital - Magdaleena Unit /ID# 253721
Tallinn, Harju, 11312, Estonia
North Estonia Medical Centre Foundation /ID# 253723
Tallinn, Harju, 13419, Estonia
MediTrials /ID# 253720
Tartu, Tartu, 50708, Estonia
CHU Toulouse - Hopital Rangueil /ID# 254148
Toulouse, Haute-Garonne, 31400, France
HCL - Hopital de la Croix-Rousse /ID# 254147
Lyon, Rhone, 69004, France
Hopital Pitie Salpetriere /ID# 253009
Paris, Île-de-France Region, 75013, France
Krankenhaus Porz am Rhein /ID# 254373
Cologne, North Rhine-Westphalia, 51149, Germany
Universitaetsmedizin Mainz /ID# 260735
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 270832
Dresden, Saxony, 01307, Germany
Immanuel Krankenhaus Berlin /ID# 253389
Buch, 13125, Germany
Fraunhofer Institute for Translational Medicine & Pharmacology ITMP /ID# 253734
Frankfurt am Main, 60596, Germany
General Hospital of Athens Laiko /ID# 252952
Athens, Attica, 11527, Greece
University General Hospital Attikon /ID# 253209
Athens, Attica, 12462, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 252951
Heraklion, Crete, 71500, Greece
Clinica Medica Especializada en Medicina Interna y Reumatologia /ID# 261156
Guatemala City, 01010, Guatemala
Clinica Medica Reumatologica /ID# 255009
Guatemala City, 01010, Guatemala
Clinica Especializada en Medicina Interna /ID# 255006
Guatemala City, 01011, Guatemala
Clínica Médica Especializada en Medicina Interna y Reumatologia /ID# 257248
Guatemala City, zona 10, Guatemala
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 254552
Pécs, Baranya, 7624, Hungary
Vital-Medicina Kft. /ID# 252876
Veszprém, Fejér, 8200, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 252877
Debrecen, Hajdú-Bihar, 4032, Hungary
Vita Verum Medical Bt. /ID# 273579
Székesfehérvár, Szekesfehervar, 8000, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 252886
Gyula, 5700, Hungary
Meir Medical Center /ID# 254187
Kfar Saba, Central District, 4428164, Israel
Hadassah Medical Center-Hebrew University /ID# 252654
Jerusalem, Jerusalem, 91120, Israel
Galilee Medical Center /ID# 252859
Nahariya, Northern District, 2210001, Israel
The Chaim Sheba Medical Center /ID# 252857
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 252858
Tel Aviv, Tel Aviv, 6423906, Israel
The Lady Davis Carmel Medical Center /ID# 253303
Haifa, 34362, Israel
Azienda Ospedaliera San Camillo Forlanini /ID# 253680
Rome, Roma, 00149, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254288
Rome, Roma, 00161, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 254138
Ancona, 60020, Italy
Azienda Ospedale-Universita Padova /ID# 253704
Padova, 35128, Italy
Azienda Ospedaliero Universitaria Pisana /ID# 254289
Pisa, 56126, Italy
Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 253269
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Hokkaido University Hospital /ID# 253306
Sapporo, Hokkaido, 060-8648, Japan
Tohoku University Hospital /ID# 253267
Sendai, Miyagi, 9808574, Japan
University of Miyazaki Hospital /ID# 253416
Miyazaki, Miyazaki, 889-1692, Japan
Okayama University Hospital /ID# 253821
Okayama, Okayama-ken, 700-8558, Japan
Shinkenko Clinic /ID# 253271
Naha, Okinawa, 900-0015, Japan
Saitama Medical Center /ID# 253263
Kawagoe, Saitama, 350-8550, Japan
Institute of Science Tokyo Hospital /ID# 254430
Bunkyo-ku, Tokyo, 113-8519, Japan
University of Yamanashi Hospital /ID# 253264
Chuo-shi, Yamanashi, 409-3898, Japan
National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 253268
Chiba, 260-8712, Japan
Hiroshima University Hospital /ID# 273658
Hiroshima, 734-8551, Japan
Riga East Clinical University Hospital /ID# 253751
Riga, Riga, 1038, Latvia
M & M Centrs LTD /ID# 253752
Adazi, LV-2164, Latvia
Daugavpils Regional Hospital /ID# 253754
Daugavpils, LV-5401, Latvia
Dr. Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 273246
Liepāja, LV-3401, Latvia
Pauls Stradins Clinical University Hospital /ID# 253750
Riga, LV-1002, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 253755
Kaunas, 50161, Lithuania
Republic Klaipeda Hospital /ID# 253759
Klaipėda, 92253, Lithuania
Klaipeda University Hospital, Klaipeda Hospital /ID# 253757
Klaipėda, 92288, Lithuania
Inlita - Santara KTC /ID# 253758
Vilnius, 08406, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 253756
Vilnius, 08661, Lithuania
Centro de Investigacion Medica Dr. Alberto Bazzoni CIMAB S.A de C.V. /ID# 261462
Torreón, Coahuila, 27000, Mexico
Morales Vargas Centro de Investigacion S.C. /ID# 254661
León, Guanajuato, 37000, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 253966
Guadalajara, Jalisco, 44650, Mexico
Grupo Clinico Catei Sociedad Civil /Id# 257700
Guadalajara, Jalisco, 44657, Mexico
Hospital de Jesus /ID# 255146
Mexico City, Mexico City, 06090, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 253965
Mexico City, Mexico City, 11850, Mexico
Medical Care & Research SA de CV /ID# 260825
Mérida, Yucatán, 97070, Mexico
Aotearoa Clinical Trials /ID# 253555
Papatoetoe, Auckland, 2025, New Zealand
North Shore Hospital /ID# 253554
Takapuna, Auckland, 0622, New Zealand
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 252964
Poznan, Greater Poland Voivodeship, 61-545, Poland
MICS Centrum Medyczne Bydgoszcz /ID# 253281
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065, Poland
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 253233
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
MICS Centrum Medyczne Warszawa /ID# 253273
Warsaw, Masovian Voivodeship, 00-874, Poland
ETYKA-Osrodek Badan Klinicznych /ID# 252967
Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland
Centro Hospitalar do Tamega e Sousa - Hospital Padre Americo /ID# 252911
Guilhufe, Porto District, 4560-136, Portugal
Hospital Garcia de Orta /ID# 252903
Almada, Setúbal District, 2805-267, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252902
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 252899
Porto, 4099-001, Portugal
Clinical Research Investigator Group /ID# 259170
Bayamón, 00960, Puerto Rico
Clinical Research Puerto Rico /ID# 256352
San Juan, 00909-1711, Puerto Rico
GCM Medical Group /ID# 253039
San Juan, 00917-3104, Puerto Rico
CMRC Headlands LLC /ID# 254882
San Juan, 00918-3501, Puerto Rico
Mindful Medical Research /ID# 253040
San Juan, 00918-3756, Puerto Rico
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 252904
Cluj-Napoca, Cluj, 400006, Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 253207
Brasov, 500283, Romania
Spitalul Clinic Sf. Maria /ID# 252905
Bucharest, 011172, Romania
Institute for Rheumatology /ID# 253172
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 253173
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 253174
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 253175
Belgrade, Beograd, 11000, Serbia
Military Medical Academy /ID# 264235
Belgrade, Beograd, 11000, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 253179
Belgrade, Beograd, 11080, Serbia
General Hospital Djordje Joanovic /ID# 253177
Zrenjanin, Vojvodina, 23000, Serbia
University Clinical Center Vojvodina /ID# 253176
Novi Sad, 21000, Serbia
ARTROMAC n.o. /ID# 253056
Košice, Košice Region, 040 11, Slovakia
Narodny Ustav Reumatickych Chorob Piestany /ID# 273341
Piešťany, Trnava Region, 921 12, Slovakia
ZAZABIE s. r .o. /ID# 255793
Košice II, 040 11, Slovakia
Thermium s.r.o. /ID# 260839
Piešťany, 921 01, Slovakia
MEDMAN s.r.o. /ID# 252950
Martin, Žilina Region, 036 01, Slovakia
Wits Clinical Research /ID# 252931
Johannesburg, Gauteng, 1864, South Africa
University of Pretoria /ID# 252932
Pretoria, Gauteng, 0001, South Africa
Dr Elsa van Duuren /ID# 254218
Pretoria, Gauteng, 0002, South Africa
Dr Asokan Naidoo /ID# 253351
Umhlanga, KwaZulu-Natal, 4319, South Africa
Winelands Medical Research - Somerset West /ID# 254614
Cape Town, Western Cape, 7130, South Africa
Arthritis Clinical Research Trials /ID# 253349
Cape Town, Western Cape, 7405, South Africa
Winelands Medical Research Centre /ID# 252934
Stellenbosch, Western Cape, 7600, South Africa
SoonChunHyang University Hospital Cheonan /ID# 254777
Cheonan-si, Chungcheongnam-do, 31151, South Korea
Chonnam National University Bitgoeul Hospital /ID# 254675
Gwangju, Gwangju Gwang Yeogsi, 61748, South Korea
Hanyang University Seoul Hospital /ID# 252955
Seoul, Seoul Teugbyeolsi, 04763, South Korea
Asan Medical Center /ID# 254022
Seoul, Seoul Teugbyeolsi, 05505, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252958
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 253123
A Coruña, A Coruna, 15006, Spain
Hospital Meixoeiro (CHUVI) /ID# 253124
Vigo, Pontevedra, 36213, Spain
Hospital Universitario Virgen de Valme /ID# 253121
Seville, 41014, Spain
University Hospital Basel /ID# 252907
Basel Town, Canton of Basel-City, 4031, Switzerland
Kantonsspital St. Gallen /ID# 252906
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Inselspital, Universitaetsspital Bern /ID# 252909
Bern, 3010, Switzerland
National Taiwan University Hospital /ID# 252937
Taipei City, Taipei, 100, Taiwan
Chang Gung Mem Hosp Keelung /ID# 253636
Keelung, 204, Taiwan
China Medical University Hospital /ID# 252936
Taichung, 40447, Taiwan
Hacettepe Universitesi Tip Fak /ID# 253266
Sihhiye, Ankara, Ankara, 06100, Turkey (Türkiye)
Gazi Universitesi Tip Fakultes /ID# 252843
Yenimahalle, Ankara, 06560, Turkey (Türkiye)
Sanko Universitesi Hastanesi /ID# 252841
Şehitkamil, Gaziantep, 27090, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakul /ID# 252839
Antalya, 07059, Turkey (Türkiye)
Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 253557
Istanbul, 34480, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 252844
Istanbul, 34899, Turkey (Türkiye)
Necmettin Erbakan Universitesi /ID# 252837
Meram Konya, 42080, Turkey (Türkiye)
Karadeniz Technical University Farabi Hospital /ID# 252845
Trabzon, 61080, Turkey (Türkiye)
North West Anglia NHS Foundation Trust /ID# 254590
Bretton, Cambridgeshire, PE3 9GZ, United Kingdom
Guy's Hospital /ID# 252978
London, Greater London, SE1 9RT, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 252982
Southampton, Hampshire, SO16 6YD, United Kingdom
Northampton General Hospital NHS Trust /ID# 254813
Northampton, Northamptonshire, NN1 5BD, United Kingdom
Western Health and Social Care Trust /ID# 254592
Londonderry, Northern Ireland, BT47 6SB, United Kingdom
Luton and Dunstable Hospital NHS Foundation Trust /ID# 255323
Luton, LU4 0DZ, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 252986
Portsmouth, PO6 3LY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2023
First Posted
May 6, 2023
Study Start
July 25, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.