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A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
Sponsor: AbbVie
Summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Official title: A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-06-20
Completion Date
2027-11
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Lutikizumab
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
Ravagalimab
Subcutaneous (SC) injection
Locations (69)
Sun Valley Arthritis Center /ID# 278331
Peoria, Arizona, United States
Private Practice - Dr. David S. Hallegua /ID# 277608
Beverly Hills, California, United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826
Chula Vista, California, United States
Newport Huntington Medical Group /ID# 272439
Huntington Beach, California, United States
Cohen Medical Centers /ID# 278341
Thousand Oaks, California, United States
The Lundquist Institute /ID# 272481
Torrance, California, United States
Inland Rheumatology & Osteoporosis Medical Group /ID# 272449
Upland, California, United States
Tekton Research - Fort Collins - East Harmony Road /ID# 272472
Fort Collins, Colorado, United States
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298
Avon Park, Florida, United States
Clinical Research Of West Florida - Phase I Unit /ID# 272428
Clearwater, Florida, United States
Neoclinical Research - Hialeah /ID# 272070
Hialeah, Florida, United States
South Florida Rheumatology /ID# 278339
Hollywood, Florida, United States
Swati Shah, MD Rheumatology /ID# 273624
Jacksonville, Florida, United States
Life Clinical Trials /ID# 272589
Margate, Florida, United States
HMD Research LLC /ID# 272432
Orlando, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755
Tampa, Florida, United States
Deerbrook Medical Associates /ID# 273439
Libertyville, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 272691
Willowbrook, Illinois, United States
Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650
Lake Charles, Louisiana, United States
AA Medical Research Center - Grand Blanc /ID# 272496
Grand Blanc, Michigan, United States
Albuquerque Center For Rheumatology /ID# 272301
Albuquerque, New Mexico, United States
Joint And Muscle Research Institute /ID# 277290
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 272387
Charlotte, North Carolina, United States
Paramount Medical Research and Consulting /ID# 272474
Middleburg Heights, Ohio, United States
Altoona Center For Clinical Research /ID# 272479
Duncansville, Pennsylvania, United States
Low Country Rheumatology /ID# 277607
Summerville, South Carolina, United States
West Tennessee Research Institute /ID# 272453
Jackson, Tennessee, United States
Arthritis & Rheumatology Research Institute /ID# 272299
Allen, Texas, United States
Tekton Research - West Gate /ID# 272270
Austin, Texas, United States
Trinity Universal Research Associates - Carrollton /ID# 272577
Carrollton, Texas, United States
Arthritis Care Of Texas /ID# 277961
Corpus Christi, Texas, United States
Accurate Clinical Research - Houston /ID# 272271
Houston, Texas, United States
Private Practice - Dr. Laila A. Hassan /ID# 272297
Houston, Texas, United States
Southwest Rheumatology Research /ID# 272268
Mesquite, Texas, United States
Texas Rheumatology Research Institute Llc /Id# 278010
Plano, Texas, United States
Epic Medical Research /ID# 272656
Red Oak, Texas, United States
Dynamed Clinical Research - Tomball /ID# 272452
Tomball, Texas, United States
Care Clinic - Calgary /ID# 274405
Calgary, Alberta, Canada
Dr. Latha Naik Medical Professional Corporation /ID# 274403
Saskatoon, Saskatchewan, Canada
L.K.N. Arthrocentrum /ID# 271932
Hlučín, Moravskoslezský kraj, Czechia
MEDICAL PLUS Research s.r.o /ID# 271926
Uherské Hradiště, Czechia
PV Medical Services s.r.o. /ID# 271934
Zlín, Czechia
Rheumateam Lahn-Dill-Siegerland /ID# 274858
Wetzlar, Hesse, Germany
Universitaetsklinikum Bonn /ID# 272808
Bonn, North Rhine-Westphalia, Germany
Krankenhaus Porz Am Rhein /ID# 272903
Cologne, North Rhine-Westphalia, Germany
MVZ Rheumatologie und Autoimmunmedizin in Hamburg /ID# 272795
Hamburg, Germany
Complex Rendelo Med Zrt. /ID# 272859
Székesfehérvár, Fejér, Hungary
Vital-Medicina Kft. /ID# 272858
Veszprém, Fejér, Hungary
Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212
Budapest, Hungary
Szegedi Tudomanyegyetem /ID# 272865
Szeged, Hungary
Mics Centrum Medyczne Bydgoszcz /ID# 272975
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Malopolskie Centrum Kliniczne /ID# 272965
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Reuma Park /ID# 272968
Warsaw, Masovian Voivodeship, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 272966
Elblag, Warmian-Masurian Voivodeship, Poland
Clinical Research Investigator Group, LLC /ID# 274821
Bayamón, Puerto Rico
Centro Reumatologico De Caguas /ID# 277918
Caguas, Puerto Rico
Reuviva Research Center, LLC /ID# 277140
Guaynabo, Puerto Rico
Santurce Clinical Trials and Infusion Center /ID# 277927
San Juan, Puerto Rico
GCM Medical Group, PSC /ID# 273016
San Juan, Puerto Rico
MEDMAN s.r.o. /ID# 278688
Martin, Žilina Region, Slovakia
SoonChunHyang University Hospital Cheonan /ID# 277624
Cheonan-si, Chungcheongnam-do, South Korea
Ajou University Hospital /ID# 273647
Suwon, Gyeonggido, South Korea
Hanyang University Seoul Hospital /ID# 273625
Seoul, Seoul Teugbyeolsi, South Korea
SMG-SNU Boramae Medical Center /ID# 273627
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 272609
A Coruña, A Coruna, Spain
Hospital Universitari Parc Tauli /ID# 272607
Sabadell, Barcelona, Spain
Hospital de Basurto /ID# 272610
Bilbao, Vizcaya, Spain
Hospital General Universitario Gregorio Maranon /ID# 272616
Madrid, Spain
Consorci Hospital General Universitario de Valencia /ID# 272615
Valencia, Spain