Clinical Research Directory
Browse clinical research sites, groups, and studies.
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Sponsor: AbbVie
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.
Official title: SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
Key Details
Gender
All
Age Range
18 Years - 63 Years
Study Type
INTERVENTIONAL
Enrollment
1014
Start Date
2023-07-25
Completion Date
2027-10
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Oral Tablets
Placebo
Oral Tablet
Locations (369)
AZ Arthritis and Rheumatology /ID# 261848
Chandler, Arizona, United States
AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
Flagstaff, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
Gilbert, Arizona, United States
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research /ID# 273555
Peoria, Arizona, United States
Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825
Phoenix, Arizona, United States
HonorHealth Rheumatology /ID# 261953
Scottsdale, Arizona, United States
Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828
Tucson, Arizona, United States
Arthritis and Rheumatism Associates /ID# 253033
Jonesboro, Arkansas, United States
Kaiser Permanente Lakeview Medical Offices /ID# 253906
Anaheim, California, United States
David S. Hallegua MD, A Professional Corporation /ID# 253902
Beverly Hills, California, United States
Wallace and Lee Center /ID# 275129
Beverly Hills, California, United States
Wallace Rheumatic Studies Center, LLC /ID# 252806
Beverly Hills, California, United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 272870
Chula Vista, California, United States
Providence - St. Jude Medical Center /ID# 252822
Fullerton, California, United States
Private Practice - Dr. Chandrakant V. Mehta /ID# 275100
Hemet, California, United States
Newport Huntington Medical Group /ID# 252827
Huntington Beach, California, United States
Moores Cancer Center at UC San Diego /ID# 253903
La Jolla, California, United States
Arthritis & Osteo Medical Ctr /ID# 252812
La Palma, California, United States
Wagdy Kades, M.D., Inc /ID# 272065
Los Angeles, California, United States
Providence St. Johns Health Center /ID# 253905
Santa Monica, California, United States
Millennium Clinical Trials /ID# 252817
Thousand Oaks, California, United States
Cohen Medical Centers /ID# 268524
Thousand Oaks, California, United States
Solace Research /ID# 275198
Tustin, California, United States
Upland Rheumatology Center /ID# 268623
Upland, California, United States
University of Colorado Hospital /ID# 253184
Aurora, Colorado, United States
Denver Arthritis Clinic /ID# 253189
Denver, Colorado, United States
Yale University School of Medicine /ID# 254567
New Haven, Connecticut, United States
Arthritis and Rheumatic Disease Specialties /ID# 253624
Aventura, Florida, United States
HARAC Research Corp. /ID# 254922
Avon Park, Florida, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623
Boca Raton, Florida, United States
Mdr Core Network, Inc /Id# 276704
Boynton Beach, Florida, United States
Bay Area Arthritis and Osteo /ID# 253597
Brandon, Florida, United States
GNP Consultants, dba, GNP Research /ID# 272868
Cooper City, Florida, United States
Duplicate_Believe Clinical Trials /ID# 255427
Coral Springs, Florida, United States
International Medical Research /ID# 253617
Daytona Beach, Florida, United States
Omega Research Debary, LLC /ID# 254939
DeBary, Florida, United States
University of Florida /ID# 261984
Gainesville, Florida, United States
Finlay Medical Research - Greenacres /ID# 274902
Greenacres City, Florida, United States
Evolution Research Center /ID# 272991
Hialeah, Florida, United States
Neoclinical Research /ID# 253614
Hialeah, Florida, United States
South Florida Rheumatology /ID# 268525
Hollywood, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272
Jacksonville, Florida, United States
UF Health Rheumatology /ID# 255351
Jacksonville, Florida, United States
Life Clinical Trials /ID# 253615
Margate, Florida, United States
Lakes Research, LLC /ID# 253621
Miami, Florida, United States
University of Miami, Division of Rheumatology /ID# 261594
Miami, Florida, United States
Ezy Medical Research /ID# 276221
Miami, Florida, United States
HMD Research LLC /ID# 253595
Orlando, Florida, United States
University of Central Florida /ID# 261112
Orlando, Florida, United States
Millennium Research /ID# 253600
Ormond Beach, Florida, United States
Vitalia Research /ID# 272642
Palm Beach Gardens, Florida, United States
Believe Clinical Trials /ID# 277004
Plant City, Florida, United States
IRIS Research and Development, LLC /ID# 253618
Plantation, Florida, United States
BayCare Medical Group /ID# 253593
St. Petersburg, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253602
Tampa, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 253899
Tampa, Florida, United States
Baycare Medical Group - Tampa /ID# 255135
Tampa, Florida, United States
Emory University School Of Medicine - Atlanta /ID# 261529
Atlanta, Georgia, United States
Trinity Research Centers /ID# 262039
Kennesaw, Georgia, United States
Atlanta Research Center For Rheumatology - Marietta /ID# 253610
Marietta, Georgia, United States
Arthritis and Rheumatology Center PC /ID# 275994
Roswell, Georgia, United States
Immunology and Rheumatology Research Associates LLC /ID# 267582
Suwanee, Georgia, United States
University of Illinois Hospital and Health Sciences System /ID# 263014
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine /ID# 264090
Chicago, Illinois, United States
Next Innovative Clinical Research - Chicago /ID# 268739
Chicago, Illinois, United States
University of Chicago Medical Center /ID# 263162
Chicago, Illinois, United States
Illinois Bone & Joint Institute - Morton /ID# 274455
Morton, Illinois, United States
Advanced Quality Medical Research /ID# 254983
Orland Park, Illinois, United States
OrthoIllinois /ID# 253188
Rockford, Illinois, United States
Greater Chicago Specialty Physicians /ID# 253021
Schaumburg, Illinois, United States
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020
Skokie, Illinois, United States
NorthShore University HealthSystem - Skokie /ID# 254568
Skokie, Illinois, United States
Deerbrook Medical Associates /ID# 253029
Vernon Hills, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 253018
Willowbrook, Illinois, United States
Western KY Rheumatology /ID# 254937
Hopkinsville, Kentucky, United States
Accurate Clinical Research (SMO/Network/Consortium) /ID# 272647
Lake Charles, Louisiana, United States
Willis Knighton /ID# 256343
Shreveport, Louisiana, United States
University of Maryland, Baltimore /ID# 262556
Baltimore, Maryland, United States
UMass Memorial Medical Center /ID# 262742
Worcester, Massachusetts, United States
Clinical Research Institute Of Michigan /ID# 273051
Clinton Township, Michigan, United States
AA Medical Research Center - Grand Blanc /ID# 253028
Grand Blanc, Michigan, United States
June DO, PC /ID# 253030
Lansing, Michigan, United States
Kansas City Physician Partners /ID# 254786
Kansas City, Missouri, United States
Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 252808
Kalispell, Montana, United States
Dartmouth-Hitchcock Medical Center /ID# 254923
Lebanon, New Hampshire, United States
Arthritis and Osteoporosis Associates of New Mexico /ID# 252818
Las Cruces, New Mexico, United States
Inspire Santa Fe Medical Group /ID# 275947
Santa Fe, New Mexico, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592
Brooklyn, New York, United States
NYU Langone Orthopedic Center /ID# 253613
New York, New York, United States
St. Lawrence Health System /ID# 253598
Potsdam, New York, United States
Urban Health Plan /ID# 268059
The Bronx, New York, United States
Joint And Muscle Research Institute /ID# 272845
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 253620
Charlotte, North Carolina, United States
Raleigh Medical Group /ID# 256328
Raleigh, North Carolina, United States
Accellacare - Salisbury /ID# 253608
Salisbury, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 254125
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center /ID# 259174
Cincinnati, Ohio, United States