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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520721-21-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy 1: Lutikizumab Monotherapy | Experimental | Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B |
|
| Substudy 1: Matching Placebo Monotherapy | Placebo Comparator | Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy. |
|
| Substudy 2: Ravagalimab Monotherapy | Experimental | Participants will be randomized to receive Ravagalimab |
|
| Substudy 2: Matching Placebo Monotherapy | Placebo Comparator | Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy |
|
| SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy | Experimental | Participants will be randomized to be administered Lutikizumab and Ravagalimab doses |
|
| Substudy 3: Matching Placebo Combination Therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutikizumab | Drug | Subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| At Week 12 |
| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to Approximately Week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Valley Arthritis Center /ID# 278331 | Recruiting | Peoria | Arizona | 85381 | United States | |
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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo Comparator |
Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy |
|
| Placebo | Drug | Subcutaneous (SC) injection |
|
| Ravagalimab | Drug | Subcutaneous (SC) injection |
|
| At Week 12 |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
| At Week 12 |
| Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) | The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). LDA is defined as a score of < or = to 3.2. | At Week 12 |
| Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP) | The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). CR remission is defined as a score of less than 2.6 | At Week 12 |
| Change from Baseline in DAS28 (CRP) | The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. | At Week 12 |
| Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI) | The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. LDA is defined as a score from 2.8 to ≤ 10. | At Week 12 |
| Percentage Of Participants Achieving CR per CDAI | The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. CR remission is defined as a score of less than 2.8 | At Week 12 |
| Arensia Research Clinic /ID# 280896 |
| Not yet recruiting |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896 | Recruiting | Jonesboro | Arkansas | 72401 | United States |
| Private Practice - Dr. David S. Hallegua /ID# 277608 | Recruiting | Beverly Hills | California | 90211 | United States |
| Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826 | Recruiting | Chula Vista | California | 91910 | United States |
|
| Newport Huntington Medical Group /ID# 272439 | Recruiting | Huntington Beach | California | 92648-5994 | United States |
| Cohen Medical Centers /ID# 278341 | Recruiting | Thousand Oaks | California | 91360 | United States |
| The Lundquist Institute /ID# 272481 | Recruiting | Torrance | California | 90502 | United States |
| Inland Rheumatology and Osteoporosis Medical Group /ID# 272449 | Recruiting | Upland | California | 91786 | United States |
| Tekton Research - Fort Collins - East Harmony Road /ID# 272472 | Recruiting | Fort Collins | Colorado | 80528 | United States |
| Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298 | Recruiting | Avon Park | Florida | 33825 | United States |
| Clinical Research Of West Florida - Phase I Unit /ID# 272428 | Recruiting | Clearwater | Florida | 33765 | United States |
| Finlay Medical Research - Greenacres /ID# 281654 | Recruiting | Greenacres City | Florida | 33467 | United States |
| Neoclinical Research - Hialeah /ID# 272070 | Recruiting | Hialeah | Florida | 33016 | United States |
| South Florida Rheumatology /ID# 278339 | Recruiting | Hollywood | Florida | 33026 | United States |
| Swati Shah, MD Rheumatology /ID# 273624 | Recruiting | Jacksonville | Florida | 32257 | United States |
| Life Clinical Trials - Colonial Drive - Margate /ID# 272589 | Recruiting | Margate | Florida | 33063 | United States |
| LeJenue Research Associates /ID# 272269 | Not yet recruiting | Miami | Florida | 33126 | United States |
| HMD Research LLC /ID# 272432 | Recruiting | Orlando | Florida | 32819 | United States |
| Vitalia Research /ID# 272478 | Recruiting | Palm Beach Gardens | Florida | 33410 | United States |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755 | Recruiting | Tampa | Florida | 33606 | United States |
|
| Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422 | Recruiting | Chicago | Illinois | 60611 | United States |
| Deerbrook Medical Associates /ID# 273439 | Recruiting | Libertyville | Illinois | 60048 | United States |
| Advanced Quality Medical Research /ID# 277824 | Recruiting | Orland Park | Illinois | 60462 | United States |
| Arnold Arthritis & Rheumatology /ID# 278354 | Recruiting | Skokie | Illinois | 60076 | United States |
| Willow Rheumatology and Wellness /ID# 272691 | Recruiting | Willowbrook | Illinois | 60527 | United States |
| Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650 | Recruiting | Lake Charles | Louisiana | 70605 | United States |
| AA Medical Research Center - Grand Blanc /ID# 272496 | Recruiting | Grand Blanc | Michigan | 48439 | United States |
| Sahni Rheumatology & Therapy /ID# 278352 | Recruiting | West Long Branch | New Jersey | 07764 | United States |
| Albuquerque Center For Rheumatology /ID# 272301 | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Northwell Health Physician Partners Rheumatology At Great Neck /ID# 275621 | Recruiting | Great Neck | New York | 11021 | United States |
| Joint And Muscle Research Institute /ID# 277290 | Recruiting | Charlotte | North Carolina | 28204 | United States |
| DJL Clinical Research - Charlotte /ID# 272387 | Recruiting | Charlotte | North Carolina | 28211-1064 | United States |
| Cape Fear Arthritis Care /ID# 272076 | Not yet recruiting | Leland | North Carolina | 28451 | United States |
| Paramount Medical Research and Consulting /ID# 272474 | Recruiting | Middleburg Heights | Ohio | 44130 | United States |
| Altoona Center For Clinical Research /ID# 272479 | Recruiting | Duncansville | Pennsylvania | 16635 | United States |
|
| Low Country Rheumatology /ID# 277607 | Recruiting | Summerville | South Carolina | 29486 | United States |
| West Tennessee Research Institute /ID# 272453 | Recruiting | Jackson | Tennessee | 38305 | United States |
| Arthritis and Rheumatology Research Institute /ID# 272299 | Recruiting | Allen | Texas | 75013 | United States |
| Tekton Research - West Gate /ID# 272270 | Recruiting | Austin | Texas | 78745 | United States |
| Trinity Universal Research Associates - Carrollton /ID# 272577 | Recruiting | Carrollton | Texas | 75007 | United States |
| Arthritis Care Of Texas /ID# 277961 | Recruiting | Corpus Christi | Texas | 78415 | United States |
|
| Accurate Clinical Research - Houston /ID# 272271 | Recruiting | Houston | Texas | 77089-6142 | United States |
| Private Practice - Dr. Laila A. Hassan /ID# 272297 | Recruiting | Houston | Texas | 77089 | United States |
| University Of Texas Health Science Center /ID# 283308 | Not yet recruiting | Houston | Texas | 77401 | United States |
| Care & Cure Clinic /ID# 281684 | Recruiting | Houston | Texas | 77909 | United States |
|
| Biopharma Informatic /ID# 279189 | Recruiting | Katy | Texas | 77494 | United States |
| Southwest Rheumatology Research /ID# 272268 | Recruiting | Mesquite | Texas | 75150 | United States |
|
| Texas Rheumatology Research Institute Llc /Id# 278010 | Recruiting | Plano | Texas | 75024 | United States |
| Epic Medical Research /ID# 272656 | Recruiting | Red Oak | Texas | 75154 | United States |
| Texas Digestive Disease Consultants - Southlake /ID# 277652 | Not yet recruiting | Southlake | Texas | 76092 | United States |
| Fort Bend Rheumatology Associates /ID# 280761 | Recruiting | Sugar Land | Texas | 77479 | United States |
| DM Clinical Research - Tomball /ID# 272452 | Recruiting | Tomball | Texas | 77375 | United States |
| DM Clinical Research -Tomball RCH /ID# 281787 | Recruiting | Tomball | Texas | 77377 | United States |
| Annapolis Rheumatology /ID# 279144 | Not yet recruiting | Fairfax | Virginia | 22311 | United States |
| Hoskinson Health & Wellness Clinic /ID# 281689 | Not yet recruiting | Gillette | Wyoming | 82718 | United States |
| Care Clinic - Calgary /ID# 274405 | Recruiting | Calgary | Alberta | T2N 4L7 | Canada |
| Centre Hospitalier Universite De Sherbrooke - Hotel-Dieu Hospital /ID# 273711 | Recruiting | Sherbrooke | Quebec | J1G 2E8 | Canada |
| Dr. Latha Naik Medical Professional Corporation /ID# 274403 | Recruiting | Saskatoon | Saskatchewan | S7H 0P4 | Canada |
| L.K.N. Arthrocentrum /ID# 271932 | Recruiting | Hlučín | Moravian-Silesian Region | 748 01 | Czechia |
| MEDICAL PLUS Research s.r.o /ID# 271926 | Recruiting | Uherské Hradiště | 686 01 | Czechia |
| PV Medical Services /ID# 271934 | Recruiting | Zlín | 760 01 | Czechia |
| Rheumateam Lahn-Dill-Siegerland /ID# 274858 | Recruiting | Wetzlar | Hesse | 35578 | Germany |
| Universitaetsklinikum Bonn /ID# 272808 | Recruiting | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Krankenhaus Porz Am Rhein /ID# 272903 | Recruiting | Cologne | North Rhine-Westphalia | 51149 | Germany |
| Mvz Rheuma /ID# 272795 | Recruiting | Hamburg | 20095 | Germany |
| Szegedi Tudomanyegyetem /ID# 272865 | Recruiting | Szeged | Csongrád megye | 6720 | Hungary |
| Complex Rendelo Med Zrt. /ID# 272859 | Recruiting | Székesfehérvár | Fejér | 8000 | Hungary |
| Vital-Medicina /ID# 272858 | Recruiting | Veszprém | Fejér | 8200 | Hungary |
| Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212 | Recruiting | Budapest | 1023 | Hungary |
| Revita Reumatologiai Rendelo (Revita Kft.) /ID# 281247 | Recruiting | Budapest | 1027 | Hungary |
| Qualiclinic /ID# 281259 | Recruiting | Budapest | 1134 | Hungary |
| Medicover Integrated Clinical Services - Bydgoszcz (SMO/Network/Consortium) /ID# 272975 | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-068 | Poland |
| Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy /ID# 281180 | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-168 | Poland |
| Malopolskie Centrum Kliniczne /ID# 272965 | Recruiting | Krakow | Lesser Poland Voivodeship | 30-149 | Poland |
| Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 281209 | Recruiting | Krakow | Lesser Poland Voivodeship | 31-011 | Poland |
| Centrum Medyczne Reuma Park /ID# 272968 | Recruiting | Warsaw | Masovian Voivodeship | 02-665 | Poland |
| Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 272966 | Recruiting | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Etyka Osrodek Badan Klinicznych /ID# 272974 | Recruiting | Olsztyn | Warmian-Masurian Voivodeship | 10-117 | Poland |
| Clinical Research Investigator Group /ID# 274821 | Recruiting | Bayamón | 00960 | Puerto Rico |
| Centro Reumatologico De Caguas /ID# 277918 | Recruiting | Caguas | 00725 | Puerto Rico |
| Reuviva Research Center /ID# 277140 | Recruiting | Guaynabo | 00968-8050 | Puerto Rico |
| Clinical Research Puerto Rico /ID# 281346 | Recruiting | San Juan | 00909-1738 | Puerto Rico |
| Santurce Clinical Trials and Infusion Center /ID# 277927 | Recruiting | San Juan | 00909 | Puerto Rico |
|
| GCM Medical Group, PSC /ID# 273016 | Recruiting | San Juan | 00917 | Puerto Rico |
| Mindful Medical Research /ID# 281521 | Recruiting | San Juan | 00918-3756 | Puerto Rico |
|
| Institute Of Rheumatology /ID# 280054 | Recruiting | Belgrade | Beograd | 11000 | Serbia |
| Institute Of Rheumatology /ID# 280055 | Recruiting | Belgrade | Beograd | 11000 | Serbia |
| Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280057 | Recruiting | Novi Sad | Juznobacki Okrug | 21000 | Serbia |
| Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280058 | Recruiting | Novi Sad | Juznobacki Okrug | 21000 | Serbia |
| MEDMAN s.r.o. /ID# 278688 | Recruiting | Martin | Žilina Region | 036 01 | Slovakia |
| Excellentis Clinical Trial Consultants /ID# 282481 | Not yet recruiting | George | Western Cape | 6529 | South Africa |
| SoonChunHyang University Hospital Cheonan /ID# 277624 | Recruiting | Cheonan-si | Chungcheongnam-do | 31151 | South Korea |
| Ajou University Hospital - Suwon-si /ID# 273647 | Recruiting | Suwon | Gyeonggido | 16499 | South Korea |
| Hanyang University Seoul Hospital /ID# 273625 | Recruiting | Seoul | Seoul Teugbyeolsi | 04763 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 273627 | Recruiting | Seoul | Seoul Teugbyeolsi | 07061 | South Korea |
| Complejo Hospitalario Universitario A Coruña /ID# 272609 | Recruiting | A Coruña | A Coruna | 15006 | Spain |
| Hospital Universitari Parc Tauli /ID# 272607 | Recruiting | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario de Valme /ID# 281266 | Recruiting | Seville | Sevilla | 41014 | Spain |
| Hospital de Basurto /ID# 272610 | Recruiting | Bilbao | Vizcaya | 48013 | Spain |
| Hospital Universitario Reina Sofia /ID# 272613 | Recruiting | Córdoba | 14004 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 272616 | Recruiting | Madrid | 28007 | Spain |
| Consorci Hospital General Universitario de Valencia /ID# 272615 | Recruiting | Valencia | 46014 | Spain |
| Taoyuan General Hospital /ID# 280044 | Recruiting | Taoyuan City | 330 | Taiwan |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000655035 | lutikizumab |
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