Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
研究单位：[1]AbbVie[2]Arizona Arthritis & Rheumatology Associates, P.C. /ID# 254767,Flagstaff,Arizona,United States,86001-6269[3]Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820,Gilbert,Arizona,United States,85297-7336[4]Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824,Glendale,Arizona,United States,85306-9802[5]AZ Arthritis and Rheumotology Research, PLLC /ID# 252831,Phoenix,Arizona,United States,85032-9306[6]Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825,Phoenix,Arizona,United States,85037[7]Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828,Tucson,Arizona,United States,85704[8]David S. Hallegua MD, A Professional Corporation /ID# 253902,Beverly Hills,California,United States,90211[9]Wallace Rheumatic Studies Center, LLC /ID# 252806,Beverly Hills,California,United States,90211[10]Providence Medical Foundation /ID# 252822,Fullerton,California,United States,92835[11]Newport Huntington Medical Group /ID# 252827,Huntington Beach,California,United States,92648-5994[12]Irvine Clinical Research /ID# 254062,Irvine,California,United States,92614[13]Moores Cancer Center at UC San Diego /ID# 253903,La Jolla,California,United States,92093[14]Providence St. John's Health Center /ID# 253905,Santa Monica,California,United States,90404-2303[15]Millennium Clinical Trials /ID# 252817,Thousand Oaks,California,United States,91360-3951[16]Denver Arthritis Clinic /ID# 253189,Denver,Colorado,United States,80230[17]Arthritis & Rheumatic Disease Specialties /ID# 253624,Aventura,Florida,United States,33180[18]HARAC Research Corp. /ID# 254922,Avon Park,Florida,United States,33825-2958[19]Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623,Boca Raton,Florida,United States,33486[20]Bay Area Arthritis and Osteo /ID# 253597,Brandon,Florida,United States,33511[21]Clinical Research of West Florida, Inc /ID# 253899,Clearwater,Florida,United States,33765[22]Believe Clinical Trials /ID# 255427,Coral Springs,Florida,United States,33065[23]International Medical Research - Daytona /ID# 253617,Daytona Beach,Florida,United States,32117[24]Omega Research Debary, LLC /ID# 254939,DeBary,Florida,United States,32713-2260[25]Sweet Hope Research Specialty Inc /ID# 253614,Hialeah,Florida,United States,33016-1897[26]UF Health Rheumatology /ID# 255351,Jacksonville,Florida,United States,32256[27]Lakes Research, LLC /ID# 253621,Miami,Florida,United States,33014[28]HMD Research LLC /ID# 253595,Orlando,Florida,United States,32819[29]Millennium Research /ID# 253600,Ormond Beach,Florida,United States,32174[30]IRIS Research and Development, LLC /ID# 253618,Plantation,Florida,United States,33324[31]Clinical Research of West Florida - Tampa /ID# 253602,Tampa,Florida,United States,33606-1246[32]BayCare Medical Group, Inc. /ID# 255135,Tampa,Florida,United States,33614-7101[33]Atlanta Research Center for Rheumatology /ID# 253610,Marietta,Georgia,United States,20060[34]Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 253018,Hinsdale,Illinois,United States,60521-3186[35]OrthoIllinois /ID# 253188,Rockford,Illinois,United States,61114-4937[36]Greater Chicago Specialty Physicians /ID# 253021,Schaumburg,Illinois,United States,60195-3106[37]Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 253020,Skokie,Illinois,United States,60076[38]Northshore University Health System Dermatology Clinical Trials Unit /ID# 254568,Skokie,Illinois,United States,60077[39]Deerbrook Medical Associates /ID# 253029,Vernon Hills,Illinois,United States,60061[40]Western KY Rheumatology, PLLC /ID# 254937,Hopkinsville,Kentucky,United States,42240[41]Rheumatology Associates PA - Portland /ID# 254933,Portland,Maine,United States,04102-2643[42]AA Medical Research Center - Grand Blanc /ID# 253028,Grand Blanc,Michigan,United States,48439[43]June DO, PC /ID# 253030,Lansing,Michigan,United States,48910[44]The Center for R
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 3 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 based on their disease activity and their original treatment assignment in Study 1 or 2. 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.
