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RECRUITING Phase 2 ClinicalTrials.gov

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT06972446

Registry updated: 2026-10-08
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Description

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.

Interventions

  • Lutikizumab (Drug)
    Subcutaneous (SC) injection
  • Placebo (Drug)
    Subcutaneous (SC) injection
  • Ravagalimab (Drug)
    Subcutaneous (SC) injection

Eligibility criteria

Inclusion Criteria: * At any time prior to the Screening Visit, participant must have been treated for \> or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2. * Participant must be on a stable dose of methotrexate (MTX) Exclusion Criteria: * Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit. * History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Locations

  • Sun Valley Arthritis Center /ID# 278331 — Peoria, Arizona, United States
  • Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896 — Jonesboro, Arkansas, 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 and 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
  • Finlay Medical Research - Greenacres /ID# 281654 — Greenacres City, 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 - Colonial Drive - Margate /ID# 272589 — Margate, Florida, United States
  • HMD Research LLC /ID# 272432 — Orlando, Florida, United States
  • Vitalia Research /ID# 272478 — Palm Beach Gardens, Florida, United States
  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755 — Tampa, Florida, United States
  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422 — Chicago, Illinois, United States
  • Deerbrook Medical Associates /ID# 273439 — Libertyville, Illinois, United States
  • Advanced Quality Medical Research /ID# 277824 — Orland Park, Illinois, United States
  • Arnold Arthritis & Rheumatology /ID# 278354 — Skokie, Illinois, United States
  • Willow Rheumatology and Wellness /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
  • Sahni Rheumatology & Therapy /ID# 278352 — West Long Branch, New Jersey, United States
  • Albuquerque Center For Rheumatology /ID# 272301 — Albuquerque, New Mexico, United States
  • Northwell Health Physician Partners Rheumatology At Great Neck /ID# 275621 — Great Neck, New York, United States
  • Joint And Muscle Research Institute /ID# 277290 — Charlotte, North Carolina, United States
  • DJL Clinical Research - Charlotte /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
  • 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
  • Arthritis and Rheumatology Research Institute - Frisco /ID# 272299 — Frisco, 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
  • Care & Cure Clinic /ID# 281684 — Houston, Texas, United States
  • Biopharma Informatic /ID# 279189 — Katy, Texas, United States
  • Southwest Rheumatology Research /ID# 272268 — Mesquite, Texas, United States
  • Texas Rheumatology Research Institute /ID# 278010 — Plano, Texas, United States
  • Epic Medical Research /ID# 272656 — Red Oak, Texas, United States
  • Fort Bend Rheumatology Associates /ID# 280761 — Sugar Land, Texas, United States
  • DM Clinical Research - Tomball /ID# 272452 — Tomball, Texas, United States
  • Dm Clinical Research -Tomball Rch /ID# 281787 — Tomball, Texas, United States
  • Care Clinic - Calgary /ID# 274405 — Calgary, Alberta, Canada
  • Centre Hospitalier Universite De Sherbrooke - Hotel-Dieu Hospital /ID# 273711 — Sherbrooke, Quebec, Canada
  • Dr. Latha Naik Medical Professional Corporation /ID# 274403 — Saskatoon, Saskatchewan, Canada
  • L.K.N. Arthrocentrum /ID# 271932 — Hlučín, Moravian-Silesian Region, Czechia
  • MEDICAL PLUS Research s.r.o /ID# 271926 — Uherské Hradiště, Czechia
  • PV Medical Services /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 Rheuma /ID# 272795 — Hamburg, Germany
  • Szegedi Tudomanyegyetem /ID# 272865 — Szeged, Csongrád megye, Hungary
  • Complex Rendelo Med Zrt. /ID# 272859 — Székesfehérvár, Fejér, Hungary
  • Vital-Medicina /ID# 272858 — Veszprém, Fejér, Hungary
  • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika /ID# 273212 — Budapest, Hungary
  • Revita Reumatologiai Rendelo (Revita Kft.) /ID# 281247 — Budapest, Hungary
  • Qualiclinic /ID# 281259 — Budapest, Hungary
  • Medicover Integrated Clinical Services - Bydgoszcz (SMO/Network/Consortium) /ID# 272975 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy /ID# 281180 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Malopolskie Centrum Kliniczne /ID# 272965 — Krakow, Lesser Poland Voivodeship, Poland
  • Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 281209 — 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
  • Etyka Osrodek Badan Klinicznych /ID# 272974 — Olsztyn, Warmian-Masurian Voivodeship, Poland
  • Clinical Research Investigator Group /ID# 274821 — Bayamón, Puerto Rico
  • Centro Reumatologico De Caguas /ID# 277918 — Caguas, Puerto Rico
  • Reuviva Research Center /ID# 277140 — Guaynabo, Puerto Rico
  • Clinical Research Puerto Rico. /ID# 281346 — San Juan, Puerto Rico
  • Santurce Clinical Trials and Infusion Center /ID# 277927 — San Juan, Puerto Rico
  • GCM Medical Group, PSC /ID# 273016 — San Juan, Puerto Rico
  • Mindful Medical Research /ID# 281521 — San Juan, Puerto Rico
  • Institute Of Rheumatology /ID# 280054 — Belgrade, Beograd, Serbia
  • Institute Of Rheumatology /ID# 280055 — Belgrade, Beograd, Serbia
  • Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280057 — Novi Sad, Juznobacki Okrug, Serbia
  • Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280058 — Novi Sad, Juznobacki Okrug, Serbia
  • 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 - Suwon-si /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
  • Hospital Universitari Parc Tauli /ID# 272607 — Sabadell, Barcelona, Spain
  • Hospital Universitario de Valme /ID# 281266 — Seville, Sevilla, Spain
  • Hospital de Basurto /ID# 272610 — Bilbao, Vizcaya, Spain
  • Complejo Hospitalario Universitario A Coruna /ID# 272609 — A Coruña, Spain
  • Hospital Universitario Reina Sofia /ID# 272613 — Córdoba, Spain
  • Hospital General Universitario Gregorio Maranon /ID# 272616 — Madrid, Spain
  • Consorci Hospital General Universitario de Valencia /ID# 272615 — Valencia, Spain
  • Taoyuan General Hospital /ID# 280044 — Taoyuan City, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record