A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154 (AIM-PMR)
Polymyalgia Rheumatica
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring Polymyalgia Rheumatica, PMR, ABBV-154, Glucocorticoid
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
- Must have had at least 2 episodes of unequivocal PMR flare.
- Must be on a stable dose of prednisone.
- Must be willing to follow the protocol-defined glucocorticoid tapering regimen.
Exclusion Criteria:
- Have been treated with a prior TNF antagonist.
- Current use of immunomodulators other than prednisone and hydroxychloroquine.
Sites / Locations
- Arthritis and Rheumatism Associates /ID# 232089
- Providence Medical Foundation /ID# 228681
- Care Access Research, Huntington Beach /ID# 228677
- Purushotham & Akther Kotha MD, Inc /ID# 245391
- Arthritis & Osteo Medical Ctr /ID# 228680
- Hans Richard Barthel, M.D., Inc /ID# 231902
- Medvin Clinical Research /ID# 228675
- Inland Rheum & Osteo Med Grp /ID# 228679
- Denver Arthritis Clinic /ID# 245736
- Delaware Arthritis /ID# 230110
- Arthritis & Rheumatic Disease Specialties /ID# 245448
- Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238
- International Medical Research /ID# 228765
- Omega Research Debary, LLC /ID# 245450
- Lakes Research, LLC /ID# 228757
- HMD Research LLC /ID# 228767
- Springfield Clinic /ID# 228840
- Four Rivers Clinical Research /ID# 228858
- Rheumatology Consultants - Clinical Research /ID# 232137
- Dartmouth-Hitchcock Medical Center /ID# 229557
- Ocean Rheumatology, PA /ID# 232539
- Hospital for Special Surgery /ID# 228577
- St. Lawrence Health System /ID# 229702
- University of Rochester Medical Center /ID# 232554
- Paramount Medical Research Con /ID# 228839
- Clinical Research Source, Inc. /ID# 231903
- Altoona Ctr Clinical Res /ID# 232493
- Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860
- West Tennessee Research Institute /ID# 228854
- Rheumatology Care Center PLLC /ID# 232306
- DM Clinical Research - Tomball /ID# 245512
- Emeritus Research Sydney /ID# 229166
- Royal Prince Alfred Hospital /ID# 244888
- BJC Health /ID# 244839
- Tasman Health Care /ID# 230829
- The Queen Elizabeth Hospital /ID# 229049
- Emeritus Research /ID# 229270
- Austin Health /ID# 229164
- Fiona Stanley Hospital /ID# 229050
- Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436
- Rheumatology Research Associates /ID# 230363
- The Waterside Clinic /ID# 230364
- CISSSBSL -Hopital regional de Rimouski /ID# 228394
- Centre de Recherche Musculo-Squelettique /ID# 228392
- CHU de Besancon - Jean Minjoz /ID# 244897
- CHU Montpellier - Hôpital Lapeyronie /ID# 228347
- Centre Hospitalier du Mans /ID# 229044
- Hopital de la Cavale Blanche /ID# 228348
- CHRU Tours - Hopital Trousseau /ID# 228349
- AP-HP - Hopital Cochin /ID# 231800
- Medius Klinik Kirchheim /ID# 228660
- Immanuel Krankenhaus Berlin /ID# 228659
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658
- Rheumazentrum Ratingen /ID# 245183
- Debreceni Egyetem Klinikai Kozpont /ID# 241674
- Obudai Egeszsegugyi Centrum Kft. /ID# 231121
- Clinexpert Kft /ID# 229677
- Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758
- Pest Megyei Flor Ferenc Korhaz /ID# 229676
- CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065
- Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793
- Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674
- Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759
- ASL 3 Genovese - Ospedale la Colletta /ID# 229282
- Azienda Ospedaliero-Universitaria di Modena /ID# 228825
- Fondazione IRCCS Policlinico /ID# 245274
- Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273
- A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080
- Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815
- Daido Clinic /ID# 230204
- NHO Nagoya Medical Center /ID# 232420
- National Hospital Organization Shimoshizu National Hospital /ID# 230500
- Matsuyama Red Cross Hospital /ID# 230458
- Sanuki Municipal Hospital /ID# 230202
- Kuwana City Medical Center /ID# 231936
- Kyushu University Beppu Hospital /ID# 232250
- Japanese Red Cross Okayama Hospital /ID# 230857
- Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532
- Osaka Medical and Pharmaceutical University Hospital /ID# 246530
- Tokyo Medical And Dental University Hospital /ID# 232206
- Toyama Prefectural Central Hospital /ID# 230616
- Hanyang University Seoul Hospital /ID# 228719
- Kyungpook National University Hospital /ID# 228716
- ZiekenhuisGroep Twente /ID# 229071
- Universitair Medisch Centrum Groningen /ID# 227727
- Medisch Centrum Leeuwarden /ID# 245442
- Maastricht Universitair Medisch Centrum /ID# 227779
- Maasstad Ziekenhuis /ID# 228064
- Optimal Clinical Trials Ltd /ID# 229048
- Aotearoa Clinical Trials /ID# 229099
- Timaru Medical Specialists Ltd /ID# 229098
- Waikato Hospital /ID# 229047
- Wellington Regional Hospital /ID# 229490
- CGM Research Trust /ID# 244893
- Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357
- Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353
- Centrum Medyczne Reuma Park /ID# 244813
- Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466
- AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951
- Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314
- Hospital Clínico Universitario de Santiago-CHUS /ID# 244868
- Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866
- Hospital Unversitario Marques de Valdecilla /ID# 229297
- Hospital Universitario Canarias /ID# 229451
- Hospital Clinic de Barcelona /ID# 229295
- Hospital General Universitario Gregorio Maranon /ID# 229302
- Hospital Clinico Universitario San Carlos /ID# 229296
- North West Anglia NHS Foundation Trust /ID# 230866
- Leicester Royal Infirmary /ID# 231967
- The Royal Free London NHS Foundation Trust /ID# 231707
- Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966
- Cardiff & Vale University Health Board /ID# 245297
- UH Coventry & Warwickshire /ID# 228588
- NHS Lothian /ID# 245293
- Liverpool University Hospitals NHS Foundation Trust /ID# 245296
- Portsmouth Hospitals University NHS Trust /ID# 245291
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
ABBV-154 Dose A
ABBV-154 Dose B
ABBV-154 Dose C
Placebo
Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Participants in this group will receive dose B of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Participants in this group will receive dose C of ABBV-154 SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.