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
NCT ID: NCT04972968
Last Updated: 2024-10-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
181 participants
INTERVENTIONAL
2021-09-09
2023-07-24
Brief Summary
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ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.
The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).
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, blood tests, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABBV-154 Dose A
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.
ABBV-154
Subcutaneous Injection
Glucocorticoid
Oral Tablet
ABBV-154 Dose B
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.
ABBV-154
Subcutaneous Injection
Glucocorticoid
Oral Tablet
ABBV-154 Dose C
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.
ABBV-154
Subcutaneous Injection
Glucocorticoid
Oral Tablet
Placebo
Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Placebo
Subcutaneous Injection
Glucocorticoid
Oral Tablet
Interventions
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ABBV-154
Subcutaneous Injection
Placebo
Subcutaneous Injection
Glucocorticoid
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* Current use of immunomodulators other than prednisone and hydroxychloroquine.
50 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Arthritis and Rheumatism Associates /ID# 232089
Jonesboro, Arkansas, United States
Providence Medical Foundation /ID# 228681
Fullerton, California, United States
Care Access Research, Huntington Beach /ID# 228677
Huntington Beach, California, United States
Purushotham & Akther Kotha MD, Inc /ID# 245391
La Mesa, California, United States
Arthritis & Osteo Medical Ctr /ID# 228680
La Palma, California, United States
Hans Richard Barthel, M.D., Inc /ID# 231902
Santa Barbara, California, United States
Medvin Clinical Research /ID# 228675
Tujunga, California, United States
Inland Rheum & Osteo Med Grp /ID# 228679
Upland, California, United States
Denver Arthritis Clinic /ID# 245736
Denver, Colorado, United States
Delaware Arthritis /ID# 230110
Lewes, Delaware, United States
Arthritis & Rheumatic Disease Specialties /ID# 245448
Aventura, Florida, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238
Boca Raton, Florida, United States
International Medical Research /ID# 228765
Daytona Beach, Florida, United States
Omega Research Debary, LLC /ID# 245450
DeBary, Florida, United States
Lakes Research, LLC /ID# 228757
Miami, Florida, United States
HMD Research LLC /ID# 228767
Orlando, Florida, United States
Springfield Clinic /ID# 228840
Springfield, Illinois, United States
Four Rivers Clinical Research /ID# 228858
Paducah, Kentucky, United States
Rheumatology Consultants - Clinical Research /ID# 232137
Tupelo, Mississippi, United States
Dartmouth-Hitchcock Medical Center /ID# 229557
Lebanon, New Hampshire, United States
Ocean Rheumatology, PA /ID# 232539
Toms River, New Jersey, United States
Hospital for Special Surgery /ID# 228577
New York, New York, United States
St. Lawrence Health System /ID# 229702
Potsdam, New York, United States
University of Rochester Medical Center /ID# 232554
Rochester, New York, United States
Paramount Medical Research Con /ID# 228839
Middleburg Heights, Ohio, United States
Clinical Research Source, Inc. /ID# 231903
Perrysburg, Ohio, United States
Altoona Ctr Clinical Res /ID# 232493
Duncansville, Pennsylvania, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860
Summerville, South Carolina, United States
West Tennessee Research Institute /ID# 228854
Jackson, Tennessee, United States
Rheumatology Care Center PLLC /ID# 232306
Bellaire, Texas, United States
DM Clinical Research - Tomball /ID# 245512
Tomball, Texas, United States
Emeritus Research Sydney /ID# 229166
Botany, New South Wales, Australia
Royal Prince Alfred Hospital /ID# 244888
Camperdown, New South Wales, Australia
BJC Health /ID# 244839
Paramatta, New South Wales, Australia
Tasman Health Care /ID# 230829
Southport, Queensland, Australia
The Queen Elizabeth Hospital /ID# 229049
Woodville South, South Australia, Australia
Emeritus Research /ID# 229270
Camberwell, Victoria, Australia
Austin Health /ID# 229164
Heidelberg, Victoria, Australia
Fiona Stanley Hospital /ID# 229050
Murdoch, Western Australia, Australia
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436
Vienna, Vienna, Austria
Rheumatology Research Associates /ID# 230363
Edmonton, Alberta, Canada
The Waterside Clinic /ID# 230364
Barrie, Ontario, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 228394
Rimouski, Quebec, Canada
Centre de Recherche Musculo-Squelettique /ID# 228392
Trois-Rivières, Quebec, Canada
CHU de Besancon - Jean Minjoz /ID# 244897
Besançon, Doubs, France
Hopital de la Cavale Blanche /ID# 228348
Brest, Finistere, France
CHU Montpellier - Hôpital Lapeyronie /ID# 228347
Montpellier, Herault, France
Centre Hospitalier du Mans /ID# 229044
Le Mans, Sarthe, France
CHRU Tours - Hopital Trousseau /ID# 228349
Chambray-lès-Tours, , France
AP-HP - Hopital Cochin /ID# 231800
Paris, , France
Medius Klinik Kirchheim /ID# 228660
Kirchheim unter Teck, Baden-Wurttemberg, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661
Berlin, , Germany
Immanuel Krankenhaus Berlin /ID# 228659
Buch, , Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658
Hamburg, , Germany
Rheumazentrum Ratingen /ID# 245183
Ratingen, , Germany
Debreceni Egyetem Klinikai Kozpont /ID# 241674
Debrecen, Hajdú-Bihar, Hungary
Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759
Zalaegerszeg, Zala County, Hungary
Clinexpert Kft /ID# 229677
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 231121
Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758
Gyula, , Hungary
Kistarcsai Flor Ferenc Korhaz /ID# 229676
Kistarcsa, , Hungary
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793
Szentes, , Hungary
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065
Székesfehérvár, , Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674
Veszprém, , Hungary
ASL 3 Genovese - Ospedale la Colletta /ID# 229282
Arenzano, Genova, Italy
A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080
Turin, Torino, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 228825
Modena, , Italy
Fondazione IRCCS Policlinico /ID# 245274
Pavia, , Italy
Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273
Siena, , Italy
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815
Udine, , Italy
Daido Clinic /ID# 230204
Nagoya, Aichi-ken, Japan
NHO Nagoya Medical Center /ID# 232420
Nagoya, Aichi-ken, Japan
National Hospital Organization Shimoshizu National Hospital /ID# 230500
Yotsukaido-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 230458
Matsuyama, Ehime, Japan
Sanuki Municipal Hospital /ID# 230202
Sanuki-shi, Kagawa-ken, Japan
Kuwana city medical center /ID# 231936
Kuwana-shi, Mie-ken, Japan
Kyushu University Beppu Hospital /ID# 232250
Beppu-shi, Oita Prefecture, Japan
Japanese Red Cross Okayama Hospital /ID# 230857
Okayama, Okayama-ken, Japan
Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532
Izumisano, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 246530
Takatsuki-shi, Osaka, Japan
Tokyo Medical And Dental University Hospital /ID# 232206
Bunkyo-ku, Tokyo, Japan
Toyama Prefectural Central Hospital /ID# 230616
Toyama, Toyama, Japan
ZiekenhuisGroep Twente /ID# 229071
Almelo, , Netherlands
Universitair Medisch Centrum Groningen /ID# 227727
Groningen, , Netherlands
Medisch Centrum Leeuwarden /ID# 245442
Leeuwarden, , Netherlands
Maastricht Universitair Medisch Centrum /ID# 227779
Maastricht, , Netherlands
Maasstad Ziekenhuis /ID# 228064
Rotterdam, , Netherlands
Optimal Clinical Trials Ltd /ID# 229048
Grafotn, Auckland, New Zealand
Aotearoa Clinical Trials /ID# 229099
Papatoetoe, Auckland, New Zealand
Timaru Medical Specialists Ltd /ID# 229098
Timaru, Canterbury, New Zealand
Waikato Hospital /ID# 229047
Hamilton, Waikato Region, New Zealand
Wellington Regional Hospital /ID# 229490
Newtown, Wellington Region, New Zealand
CGM Research Trust /ID# 244893
Christchurch Central, , New Zealand
AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951
Poznan, Greater Poland Voivodeship, Poland
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314
Poznan, Greater Poland Voivodeship, Poland
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Medyczne Reuma Park /ID# 244813
Warsaw, Masovian Voivodeship, Poland
Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466
Bialystok, Podlaskie Voivodeship, Poland
Hanyang University Seoul Hospital /ID# 228719
Seoul, Seoul Teugbyeolsi, South Korea
Kyungpook National University Hospital /ID# 228716
Daegu, , South Korea
Hospital Clínico Universitario de Santiago-CHUS /ID# 244868
Santiago de Compostela, A Coruna, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866
Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla /ID# 229297
Santander, Cantabria, Spain
Hospital Universitario Canarias /ID# 229451
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Clinic de Barcelona /ID# 229295
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 229302
Madrid, , Spain
Hospital Clinico Universitario San Carlos /ID# 229296
Madrid, , Spain
North West Anglia NHS Foundation Trust /ID# 230866
Bretton, Cambridgeshire, United Kingdom
Leicester Royal Infirmary /ID# 231967
Leicester, England, United Kingdom
The Royal Free London NHS Foundation Trust /ID# 231707
London, London, City of, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966
Norwich, Norfolk, United Kingdom
Cardiff & Vale University Health Board /ID# 245297
Cardiff, Wales, United Kingdom
UH Coventry & Warwickshire /ID# 228588
Coventry, , United Kingdom
NHS Lothian /ID# 245293
Edinburgh, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 245296
Liverpool, , United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 245291
Portsmouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-000648-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M20-370
Identifier Type: -
Identifier Source: org_study_id
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