Back to resultsA 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)
Primary Purpose
Polymyalgia Rheumatica
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-154
Placebo
Glucocorticoid
Sponsored by
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
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ABBV-154 Dose A
ABBV-154 Dose B
ABBV-154 Dose C
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
Time to Flare
Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
Secondary Outcome Measures
Percentage of Participants Achieving Flare-Free State
Percentage of participants achieving flare-free state.
Cumulative Glucocorticoid Dose
Cumulative glucocorticoid dose.
Change from Baseline in Glucocorticoid Dose
Change from Baseline in glucocorticoid dose.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04972968
Brief Title
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
Acronym
AIM-PMR
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Business Decision
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
July 24, 2023 (Actual)
Study Completion Date
July 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
Polymyalgia Rheumatica, PMR, ABBV-154, Glucocorticoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABBV-154 Dose A
Arm Type
Experimental
Arm Description
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.
Arm Title
ABBV-154 Dose B
Arm Type
Experimental
Arm Description
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.
Arm Title
ABBV-154 Dose C
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo SC eow for 52 weeks. In addition, participants will receive a glucocorticoid oral tablet taper.
Intervention Type
Drug
Intervention Name(s)
ABBV-154
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Time to Flare
Description
Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
Time Frame
Up to Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Flare-Free State
Description
Percentage of participants achieving flare-free state.
Time Frame
Up to Week 24
Title
Cumulative Glucocorticoid Dose
Description
Cumulative glucocorticoid dose.
Time Frame
Week 24
Title
Change from Baseline in Glucocorticoid Dose
Description
Change from Baseline in glucocorticoid dose.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arthritis and Rheumatism Associates /ID# 232089
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401-6251
Country
United States
Facility Name
Providence Medical Foundation /ID# 228681
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Care Access Research, Huntington Beach /ID# 228677
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Purushotham & Akther Kotha MD, Inc /ID# 245391
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Arthritis & Osteo Medical Ctr /ID# 228680
City
La Palma
State/Province
California
ZIP/Postal Code
90623-1728
Country
United States
Facility Name
Hans Richard Barthel, M.D., Inc /ID# 231902
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States
Facility Name
Medvin Clinical Research /ID# 228675
City
Tujunga
State/Province
California
ZIP/Postal Code
91042-2706
Country
United States
Facility Name
Inland Rheum & Osteo Med Grp /ID# 228679
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Denver Arthritis Clinic /ID# 245736
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Delaware Arthritis /ID# 230110
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties /ID# 245448
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
International Medical Research /ID# 228765
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Omega Research Debary, LLC /ID# 245450
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
Lakes Research, LLC /ID# 228757
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
HMD Research LLC /ID# 228767
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Springfield Clinic /ID# 228840
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-3749
Country
United States
Facility Name
Four Rivers Clinical Research /ID# 228858
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Rheumatology Consultants - Clinical Research /ID# 232137
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801-4949
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 229557
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Ocean Rheumatology, PA /ID# 232539
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Hospital for Special Surgery /ID# 228577
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
St. Lawrence Health System /ID# 229702
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Facility Name
University of Rochester Medical Center /ID# 232554
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Paramount Medical Research Con /ID# 228839
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Clinical Research Source, Inc. /ID# 231903
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Altoona Ctr Clinical Res /ID# 232493
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486-7887
Country
United States
Facility Name
West Tennessee Research Institute /ID# 228854
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Rheumatology Care Center PLLC /ID# 232306
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401-2900
Country
United States
Facility Name
DM Clinical Research - Tomball /ID# 245512
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Emeritus Research Sydney /ID# 229166
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
Royal Prince Alfred Hospital /ID# 244888
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
BJC Health /ID# 244839
City
Paramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Tasman Health Care /ID# 230829
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
The Queen Elizabeth Hospital /ID# 229049
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Emeritus Research /ID# 229270
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Austin Health /ID# 229164
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 229050
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436
City
Vienna
State/Province
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Rheumatology Research Associates /ID# 230363
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
The Waterside Clinic /ID# 230364
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
CISSSBSL -Hopital regional de Rimouski /ID# 228394
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique /ID# 228392
City
Trois-rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
CHU de Besancon - Jean Minjoz /ID# 244897
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Montpellier - Hôpital Lapeyronie /ID# 228347
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34090
Country
France
Facility Name
Centre Hospitalier du Mans /ID# 229044
City
Le Mans CEDEX 9
State/Province
Sarthe
ZIP/Postal Code
72037
Country
France
Facility Name
Hopital de la Cavale Blanche /ID# 228348
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHRU Tours - Hopital Trousseau /ID# 228349
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
AP-HP - Hopital Cochin /ID# 231800
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Medius Klinik Kirchheim /ID# 228660
City
Kirchheim unter Teck
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73230
Country
Germany
Facility Name
Immanuel Krankenhaus Berlin /ID# 228659
City
Berlin-buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Rheumazentrum Ratingen /ID# 245183
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 241674
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. /ID# 231121
City
Budapest
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Clinexpert Kft /ID# 229677
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz /ID# 229676
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
ASL 3 Genovese - Ospedale la Colletta /ID# 229282
City
Arenzano
State/Province
Genova
ZIP/Postal Code
16011
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena /ID# 228825
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Fondazione IRCCS Policlinico /ID# 245274
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Daido Clinic /ID# 230204
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
NHO Nagoya Medical Center /ID# 232420
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Hospital Organization Shimoshizu National Hospital /ID# 230500
City
Yotsukaido-shi
State/Province
Chiba
ZIP/Postal Code
284-0003
Country
Japan
Facility Name
Matsuyama Red Cross Hospital /ID# 230458
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Sanuki Municipal Hospital /ID# 230202
City
Sanuki-shi
State/Province
Kagawa
ZIP/Postal Code
769-2393
Country
Japan
Facility Name
Kuwana City Medical Center /ID# 231936
City
Kuwana-shi
State/Province
Mie
ZIP/Postal Code
511-0061
Country
Japan
Facility Name
Kyushu University Beppu Hospital /ID# 232250
City
Beppu-shi
State/Province
Oita
ZIP/Postal Code
874-0838
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital /ID# 230857
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532
City
Izumisano-shi
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital /ID# 246530
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital /ID# 232206
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Toyama Prefectural Central Hospital /ID# 230616
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Hanyang University Seoul Hospital /ID# 228719
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital /ID# 228716
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
ZiekenhuisGroep Twente /ID# 229071
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 227727
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden /ID# 245442
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum /ID# 227779
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Maasstad Ziekenhuis /ID# 228064
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Optimal Clinical Trials Ltd /ID# 229048
City
Grafotn
State/Province
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Aotearoa Clinical Trials /ID# 229099
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Timaru Medical Specialists Ltd /ID# 229098
City
Timaru
State/Province
Canterbury
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
Waikato Hospital /ID# 229047
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Wellington Regional Hospital /ID# 229490
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
CGM Research Trust /ID# 244893
City
Christchurch Central
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-224
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Medyczne Reuma Park /ID# 244813
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Facility Name
Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-707
Country
Poland
Facility Name
AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 244868
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 229297
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Canarias /ID# 229451
City
San Cristóbal de La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 229295
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 229302
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 229296
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
North West Anglia NHS Foundation Trust /ID# 230866
City
Bretton
State/Province
Cambridgeshire
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Leicester Royal Infirmary /ID# 231967
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
The Royal Free London NHS Foundation Trust /ID# 231707
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Cardiff & Vale University Health Board /ID# 245297
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
UH Coventry & Warwickshire /ID# 228588
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
NHS Lothian /ID# 245293
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Facility Name
Liverpool University Hospitals NHS Foundation Trust /ID# 245296
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Portsmouth Hospitals University NHS Trust /ID# 245291
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
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
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