Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04888585
Collaborator
(none)
473
223
5
35.3
2.1
0.1

Study Details

Study Description

Brief Summary

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors place the participants in 1 of 5 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Participants 18-75 years of age with moderate to severe RA will be enrolled. Around 425 participants will be enrolled in the study in approximately 270 sites worldwide.

The study is compromised of a 12 week placebo-controlled period, a double-blind long term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group will be re-randomized to receive ABBV-154 in 2 different doses SC every other week (eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154.

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
473 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)
Actual Study Start Date :
Jun 2, 2021
Anticipated Primary Completion Date :
Nov 25, 2022
Anticipated Study Completion Date :
May 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose A of ABBV-154

Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 12 weeks in the placebo-controlled period, 66 weeks in the long term extension (LTE) period 1 and 104 weeks in LTE period 2.

Drug: ABBV-154
Subcutaneous Injection

Experimental: Dose B of ABBV-154

Participants in this group will receive dose B of ABBV-154 SC eow for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Drug: ABBV-154
Subcutaneous Injection

Experimental: Dose C of ABBV-154 EOW

Participants in this group will receive dose C of ABBV-154 SC eow for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Drug: ABBV-154
Subcutaneous Injection

Experimental: Dose C of ABBV-154 E4W

Participants in this group will receive dose C of ABBV-154 SC every 4 weeks (e4w) for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Drug: ABBV-154
Subcutaneous Injection

Experimental: Placebo

Participants in this group will receive placebo SC eow for 12 weeks in the placebo-controlled period and will be re-randomized in 1:1 ratio to receive ABBV-154 dose B or C respectively SC eow for 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Drug: ABBV-154
Subcutaneous Injection

Drug: Placebo
Subcutaneous Injection

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response [At 12 weeks]

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity measured on a Numerical Rating Scale of 0 to 10 (NRS) Patient's Global Assessment of Disease Activity (NRS) Patient's Assessment of Pain (NRS) Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

Secondary Outcome Measures

  1. Change in Disease Activity Score (DAS) 28 (CRP) from Baseline [Up to 12 weeks]

    The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

  2. Change in Clinical Disease Activity Index (CDAI) from Baseline [Up to 12 weeks]

    CDAI is a composite index for assessing disease activity based on the sum of the total 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 Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.

  3. Percentage of Participants Achieving American College of Rheumatology 20 % (ACR20) Response [At 12 weeks]

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity (NRS) Patient's Global Assessment of Disease Activity (NRS) Patient's Assessment of Pain (NRS) Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

  4. Percentage of Participants Achieving American College of Rheumatology 70 % (ACR70) Response [At 12 weeks]

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity (NRS) Patient's Global Assessment of Disease Activity (NRS) Patient's Assessment of Pain (NRS) Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

  5. Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 [At 12 weeks]

    Low disease activity (LDA) was defined as a DAS28 score less than or equal to 3.2. The DAS28 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 Physician's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

  6. Percentage of Participants Achieving LDA Defined by CDAI <= 10 [At 12 weeks]

    Low disease activity based on CDAI is defined as a CDAI score less than or equal to 10. CDAI is a composite index for assessing disease activity based on the sum of the total 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 Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.

  7. Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 [At 12 weeks]

    Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 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 hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

  8. Percentage of Participants Achieving CR Defined by CDAI <= 2.8 [At 12 weeks]

    Clinical Remission was defined by CDAI as a score less than or equal to 2.8. CDAI is a composite index for assessing disease activity based on the summation of the total 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 Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.

  9. Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline [Up to 12 weeks]

    The Health Assessment Questionnaire - Disability Index is a participant-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.

  • Participant has >= 6 swollen joints (based on 66 joint count) and >=6 tender joints (based on 68 joint count) at baseline.

  • Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.

  • Participants must be on stable dose of methotrexate (MTX).

Exclusion Criteria:
  • Participant discontinued prior adalimumab therapy due to intolerability or toxicity.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Elite Clinical Studies, LLC /ID# 228227 Phoenix Arizona United States 85018
2 Arthritis and Rheumatism Associates /ID# 228201 Jonesboro Arkansas United States 72401-6251
3 Providence Medical Foundation /ID# 228104 Fullerton California United States 92835
4 Care Access Research, Huntington Beach /ID# 228163 Huntington Beach California United States 92648
5 San Diego Rheumatology /ID# 228120 La Mesa California United States 91942
6 Arthritis & Osteo Medical Ctr /ID# 228239 La Palma California United States 90623-1728
7 Pacific Arthritis Care Center - Los Angeles /ID# 229330 Los Angeles California United States 90045-6200
8 California Medical Research Associates /ID# 230131 Northridge California United States 91324
9 Arthritis Care And Research Center ACRC /ID# 230099 Poway California United States 92064
10 East Bay Rheumatology Medical /ID# 228099 San Leandro California United States 94578
11 Millennium Clinical Trials /ID# 230618 Thousand Oaks California United States 91360-3951
12 The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241 Torrance California United States 90502
13 Medvin Clinical Research /ID# 228181 Tujunga California United States 91042-2706
14 Inland Rheum & Osteo Med Grp /ID# 228204 Upland California United States 91786
15 Comprehensive Rheumatology Center /ID# 230132 West Hills California United States 91307-2003
16 Denver Arthritis Clinic /ID# 228172 Denver Colorado United States 80230
17 New England Research Associates, LLC /ID# 230127 Bridgeport Connecticut United States 06606-1827
18 Stamford Therapeutics Consorti /ID# 229214 Stamford Connecticut United States 06905
19 Delaware Arthritis /ID# 229413 Lewes Delaware United States 19958
20 Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229 Boca Raton Florida United States 33486
21 Bay Area Arthritis and Osteo /ID# 228075 Brandon Florida United States 33511
22 Clinical Research of West Florida, Inc /ID# 228128 Clearwater Florida United States 33765
23 International Medical Research - Daytona /ID# 228069 Daytona Beach Florida United States 32117
24 Omega Research Debary, LLC /ID# 228293 DeBary Florida United States 32713-2260
25 Sweet Hope Research Specialty Inc /ID# 228753 Hialeah Florida United States 33016-1897
26 University of Florida /ID# 228242 Jacksonville Florida United States 32209
27 Lakes Research, LLC /ID# 228665 Miami Florida United States 33014
28 University of Miami /ID# 228737 Miami Florida United States 33136
29 Suncoast Clinical Research /ID# 228237 New Port Richey Florida United States 34652
30 Omega Research Maitland, LLC /ID# 229966 Orlando Florida United States 32808
31 HMD Research LLC /ID# 228185 Orlando Florida United States 32819
32 Millennium Research /ID# 228183 Ormond Beach Florida United States 32174
33 Arthritis Center, Inc. /ID# 228209 Palm Harbor Florida United States 34684
34 BayCare Medical Group /ID# 228289 Saint Petersburg Florida United States 33705
35 West Broward Rheumatology Associates /ID# 228603 Tamarac Florida United States 33321
36 Clinical Research of West Florida - Tampa /ID# 228186 Tampa Florida United States 33606-1246
37 Conquest Research /ID# 230560 Winter Park Florida United States 32789
38 Florida Medical Clinic /ID# 228236 Zephyrhills Florida United States 33542
39 Arthritis and Rheumatology /ID# 228743 Atlanta Georgia United States 30342
40 Jefrey D. Lieberman, MD, P.C. /ID# 230129 Decatur Georgia United States 30033
41 Arthritis Center of North GA /ID# 228769 Gainesville Georgia United States 30501
42 Atlanta Research Center for Rheumatology /ID# 230430 Marietta Georgia United States 20060
43 Great Lakes Clinical Trials /ID# 228699 Chicago Illinois United States 60640
44 Greater Chicago Specialty Physicians /ID# 228282 Schaumburg Illinois United States 60195-3106
45 Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174 Skokie Illinois United States 60076
46 Springfield Clinic /ID# 228124 Springfield Illinois United States 62702-3749
47 Beacon Medical Group Clinical Research /ID# 229153 Granger Indiana United States 46530
48 University of Iowa Hospitals and Clinics /ID# 229217 Iowa City Iowa United States 52242
49 Four Rivers Clinical Research /ID# 230109 Paducah Kentucky United States 42001
50 The Arthritis & Diabetes Clinic, Inc. /ID# 228221 Monroe Louisiana United States 71203
51 Klein and Associates MD /ID# 230145 Hagerstown Maryland United States 21740
52 Klein and Associates MD - Hagerstown /ID# 230143 Hagerstown Maryland United States 21742
53 The Center for Rheumatology and Bone Research /ID# 228617 Wheaton Maryland United States 20902
54 AA Medical Research Center /ID# 228604 Grand Blanc Michigan United States 48439
55 Advanced Rheumatology, PC /ID# 228684 Lansing Michigan United States 48910
56 June DO, PC /ID# 229838 Lansing Michigan United States 48910
57 Arthritis Associates /ID# 230188 Hattiesburg Mississippi United States 39402
58 Rheumatology Consultants - Clinical Research /ID# 229208 Tupelo Mississippi United States 38801-4949
59 Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283 Saint Louis Missouri United States 63119-3845
60 West County Rheumatology /ID# 228102 Saint Louis Missouri United States 63131-1703
61 Logan Health Research /ID# 228273 Kalispell Montana United States 59901
62 Advanced Biomedical Research of America /ID# 228596 Las Vegas Nevada United States 89123
63 Innovative Health Research /ID# 229209 Las Vegas Nevada United States 89128
64 Arthritis and Osteoporosis Associates /ID# 229418 Freehold New Jersey United States 07728-8307
65 Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602 Voorhees New Jersey United States 08043
66 Albuquerque Center For Rheumatology /ID# 228709 Albuquerque New Mexico United States 87102
67 Albuquerque Clinical Trials, Inc /ID# 228925 Albuquerque New Mexico United States 87102
68 Arthritis and Osteo Assoc /ID# 228662 Las Cruces New Mexico United States 88011
69 Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710 Orchard Park New York United States 14127
70 St. Lawrence Health System /ID# 229508 Potsdam New York United States 13676
71 DJL Clinical Research, PLLC /ID# 230133 Charlotte North Carolina United States 28210-8508
72 Cape Fear Arthritis Care /ID# 228747 Leland North Carolina United States 28451
73 PMG Research of Salisbury /ID# 230627 Salisbury North Carolina United States 28144
74 Trinity Health Med Arts Clinic /ID# 228202 Minot North Dakota United States 58701
75 University of Cincinnati /ID# 229212 Cincinnati Ohio United States 45267-0585
76 Paramount Medical Research Con /ID# 228254 Middleburg Heights Ohio United States 44130
77 Arthritis Assoc of NW Ohio /ID# 228936 Toledo Ohio United States 43606
78 Arthritis and Rheumatology Center of Oklahoma /ID# 228975 Oklahoma City Oklahoma United States 73102
79 Rheumatology Associates of Oklahoma /ID# 228701 Oklahoma City Oklahoma United States 73116-7226
80 Advanced Rheumatology & Arthritis Wellness Center /ID# 228608 Cranberry Township Pennsylvania United States 16066
81 Altoona Ctr Clinical Res /ID# 230058 Duncansville Pennsylvania United States 16635
82 Arthritis Group /ID# 229777 Philadelphia Pennsylvania United States 19152
83 PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742 Wyomissing Pennsylvania United States 19610
84 Columbia Arthritis Center /ID# 228705 Columbia South Carolina United States 29204
85 West Tennessee Research Institute /ID# 228257 Jackson Tennessee United States 38305
86 Arthritis and Rheumatology Research Institute, PLLC /ID# 228937 Allen Texas United States 75013-6147
87 Allen Arthritis /ID# 228712 Allen Texas United States 75013
88 Trinity Universal Research Associates - Carrollton /ID# 230104 Carrollton Texas United States 75007
89 Adriana Pop-Moody MD Clinic PA /ID# 230062 Corpus Christi Texas United States 78404
90 Rheumatology Clinic of Houston /ID# 228178 Houston Texas United States 77065
91 West Texas Clinical Research /ID# 228276 Lubbock Texas United States 79410-1198
92 P&I Clinical Research /ID# 230183 Lufkin Texas United States 75904-3132
93 SW Rheumatology Res. LLC /ID# 228088 Mesquite Texas United States 75150
94 Trinity Universal Research Associates, Inc /ID# 228238 Plano Texas United States 75024-5283
95 Epic Medical Research /ID# 228097 Red Oak Texas United States 75154-3981
96 Sun Research Institute /ID# 228768 San Antonio Texas United States 78215
97 Advanced Rheumatology of Houston /ID# 228170 The Woodlands Texas United States 77382
98 DM Clinical Research - Tomball /ID# 228112 Tomball Texas United States 77375
99 Arthritis & Osteoporosis Clinic /ID# 228736 Waco Texas United States 76710
100 Tidewater Physicians Medical Center /ID# 230130 Newport News Virginia United States 23606-4434
101 Arthritis Northwest, PLLC /ID# 228275 Spokane Washington United States 99204-2302
102 Emeritus Research Sydney /ID# 230070 Botany New South Wales Australia 2019
103 BJC Health /ID# 229015 Paramatta New South Wales Australia 2150
104 Rheumatology Research Unit Sunshine Coast /ID# 229017 Maroochydore Queensland Australia 4558
105 The Queen Elizabeth Hospital /ID# 230071 Woodville South South Australia Australia 5011
106 Emeritus Research /ID# 229018 Camberwell Victoria Australia 3124
107 Rheumatology Research Associates /ID# 227818 Edmonton Alberta Canada T5M 0H4
108 Manitoba Clinic /ID# 227822 Winnipeg Manitoba Canada R3A 1M3
109 Groupe de Recherche en Maladies Osseuses Inc /ID# 227821 Sainte-foy Quebec Canada G1V 3M7
110 Centre de Recherche Musculo-Squelettique /ID# 227824 Trois-rivières Quebec Canada G8Z 1Y2
111 Dr. Latha Naik /ID# 227823 Saskatoon Saskatchewan Canada S7K 3H3
112 Revmatologicky ustav v Praze /ID# 229188 Praha Czechia 128 00
113 PV MEDICAL Services s.r.o. /ID# 228265 Praha Czechia 130 00
114 Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775 Praha Czechia 140 00
115 Fakultni Nemocnice v Motole /ID# 231622 Praha Czechia 150 06
116 MEDICAL PLUS, s.r.o. /ID# 228030 Uherske Hradiste Czechia 686 01
117 RHEUMA s.r.o. /ID# 230850 Velke Bilovice Czechia 691 02
118 Rheumazentrum Ruhrgebiet /ID# 227850 Herne Nordrhein-Westfalen Germany 44649
119 Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526 Berlin Germany 10117
120 MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785 Hamburg Germany 20095
121 General Hospital of Athens Gennimatas /ID# 227806 Athens Attiki Greece 11527
122 University General Hospital of Heraklion PA.G.N.I /ID# 227804 Heraklion Kriti Greece 71500
123 424 General MILITARY Hospital /ID# 227805 Efkarpia (Thessalonikis) Thessaloniki Greece 56429
124 General Hospital of Thessaloniki Hippokrateio /ID# 229614 Thessaloniki Greece 54642
125 Debreceni Egyetem Klinikai Kozpont /ID# 228371 Debrecen Hajdu-Bihar Hungary 4032
126 Obudai Egeszsegugyi Centrum Kft. /ID# 228359 Budapest Pest Hungary 1036
127 DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365 Balatonfüred Hungary 8230
128 Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671 Budapest Hungary 1023
129 Revita Reumatologiai Rendelo /ID# 227668 Budapest Hungary 1027
130 CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670 Szekesfehervar Hungary 8000
131 Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669 Veszprém Hungary 8200
132 Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374 Zalaegerszeg Hungary 8900
133 The Chaim Sheba Medical Center /ID# 226797 Ramat Gan Tel-Aviv Israel 5265601
134 Tel Aviv Sourasky Medical Center /ID# 228341 Tel Aviv-Yafo Tel-Aviv Israel 6423906
135 Rambam Health Care Campus /ID# 226798 Haifa Israel 3109601
136 Bnai Zion Medical Center /ID# 226801 Haifa Israel 3339419
137 The Lady Davis Carmel Medical Center /ID# 226802 Haifa Israel 34362
138 Meir Medical Center /ID# 226800 Kfar Saba Israel 4428164
139 Policlinico Universitario Campus Bio-Medico /ID# 228917 Rome Lazio Italy 00128
140 Ospedale San Raffaele IRCCS /ID# 228582 Milan Lombardia Italy 20132
141 Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581 Ancona Italy 60126
142 Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583 Palermo Italy 90127
143 Azienda USL di Reggio Emilia-IRCCS-Arcispedale Santa Maria Nuova /ID# 228734 Reggio Emilia Italy 42121
144 Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899 Nagoya-shi Aichi Japan 455-8530
145 Daido Clinic /ID# 229280 Nagoya-shi Aichi Japan 457-8511
146 Sugimoto rheumatology and internal medicine clinic /ID# 229495 Fukui-shi Fukui Japan 910-0068
147 National Hospital Organization Kyushu Medical Center /ID# 228642 Fukuoka shi Fukuoka Japan 810-8563
148 Hamanomachi Hospital /ID# 228644 Fukuoka-shi Fukuoka Japan 810-8539
149 Shono Rheumatism Clinic /ID# 229054 Fukuoka-shi Fukuoka Japan 814-0002
150 Katayama Orthopedic Rheumatology Clinic /ID# 229277 Asahikawa-shi Hokkaido Japan 078-8243
151 Sagawa Akira Rheumatology Clin /ID# 228787 Sapporo-shi Hokkaido Japan 060-0001
152 Matsubara Mayflower Hospital /ID# 228948 Kato-shi Hyogo Japan 673-1462
153 Sanuki Municipal Hospital /ID# 229276 Sanuki-shi Kagawa Japan 769-2393
154 Bay Side Misato Medical Center /ID# 228947 Kochi-shi Kochi Japan 781-0112
155 Kumamoto Orthopaedic Hospital /ID# 228641 Kumamoto shi Kumamoto Japan 8620975
156 Medical Corporation Keiai Kai Clinic /ID# 228547 Miyazaki-shi Miyazaki Japan 880-0053
157 Sasebo Chuo Hospital /ID# 229168 Sasebo-shi Nagasaki Japan 857-1195
158 Nagaoka Red Cross Hospital /ID# 229962 Nagaoka-shi Niigata Japan 940-2085
159 National Hospital Organization Osaka Minami Medical Center /ID# 229174 Kawachinagano Shi Osaka Japan 586-8521
160 Osaka City General Hospital /ID# 228786 Osaka-shi Osaka Japan 534-0021
161 Japanese Red Cross Osaka Hospital /ID# 229816 Osaka-shi Osaka Japan 543-8555
162 Azuma Rheumatology Clinic /ID# 230078 Sayama-shi Saitama Japan 350-1305
163 St.Luke's International Hospital /ID# 229492 Chuo-ku Tokyo Japan 104-8560
164 National Hospital Organization Tokyo Medical Center /ID# 228720 Meguro-ku Tokyo Japan 152-8902
165 Medical Corporation Uchida Clinic /ID# 229494 Sumida-ku Tokyo Japan 130-0013
166 Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354 Shimonoseki-shi Yamaguchi Japan 752-0976
167 SoonChunHyang University CheonAn Hospital /ID# 228146 Cheonan-si Chungcheongnamdo Korea, Republic of 31151
168 Yonsei University Health System Severance Hospital /ID# 227659 Seoul Seoul Teugbyeolsi Korea, Republic of 03722
169 Hanyang University Seoul Hospital /ID# 227658 Seoul Seoul Teugbyeolsi Korea, Republic of 04763
170 Kyungpook National University Hospital /ID# 227657 Daegu Korea, Republic of 41944
171 Inha University Hospital /ID# 227656 Incheon Korea, Republic of 22332
172 Asan Medical Center /ID# 227655 Seoul Korea, Republic of 05505
173 ZiekenhuisGroep Twente /ID# 229072 Almelo Netherlands 7609 PP
174 Academisch Medisch Centrum /ID# 227234 Amsterdam Netherlands 1105 AZ
175 Maastricht Universitair Medisch Centrum /ID# 227235 Maastricht Netherlands 6229 HX
176 Middlemore Clinical Trials /ID# 229012 Papatoetoe Auckland New Zealand 2025
177 Timaru Medical Specialists Ltd /ID# 229013 Timaru Canterbury New Zealand 7910
178 Wellington Regional Hospital /ID# 233517 Newtown Wellington New Zealand 6021
179 Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939 Bydgoszcz Kujawsko-pomorskie Poland 85-168
180 AMICARE Sp. z o.o. sp.k. /ID# 231327 Lodz Lodzkie Poland 90-644
181 Duplicate_Centrum Medyczne Reuma Park /ID# 227170 Warszawa Mazowieckie Poland 02-691
182 SANUS Szpital Specjalistyczny /ID# 227171 Stalowa Wola Podkarpackie Poland 37-450
183 ClinicMed Daniluk, Nowak Sp.j. /ID# 227919 Bialystok Podlaskie Poland 15-879
184 Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047 Gdansk Pomorskie Poland 80-546
185 Medycyna Kliniczna /ID# 231133 Warsaw Poland 00-874
186 GCM Medical Group PSC /ID# 228981 San Juan Puerto Rico 00917-3104
187 Mindful Medical Research /ID# 228982 San Juan Puerto Rico 00918-3756
188 Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755 Moscow Moskovskaya Oblast Russian Federation 129110
189 LLC Family Outpatient Clinic № /ID# 227926 Korolev Moskva Russian Federation 141060
190 Family Clinic /ID# 227929 Yekaterinburg Sverdlovskaya Oblast Russian Federation 620109
191 Kazan State Medical University /ID# 227927 Kazan Tatarstan, Respublika Russian Federation 420012
192 Central Clinical Hospital of Russian Academy of Science /ID# 229438 Moscow Russian Federation 117593
193 Euromedservice /ID# 227933 Pushkin Russian Federation 196603
194 Clinical Rheumatologic Hospital No 25 /ID# 227922 St. Petersburg Russian Federation 190068
195 MEDMAN s.r.o. /ID# 227826 Martin Slovakia 036 01
196 Reum.hapi s.r.o. /ID# 227825 Nove Mesto nad Vahom Slovakia 915 01
197 Thermium s.r.o. /ID# 227816 Piestany Slovakia 921 01
198 REUMAMED POPRAD s.r.o. /ID# 229628 Poprad Slovakia 058 01
199 Reumex, s.r.o. /ID# 227827 Rimavska Sobota Slovakia 979 01
200 Hospital Clínico Universitario de Santiago-CHUS /ID# 227420 Santiago de Compostela A Coruna Spain 15706
201 Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666 Sabadell Barcelona Spain 08208
202 Hospital Regional de Malaga /ID# 227418 Málaga Malaga Spain 29010
203 Hospital Universitario Basurto /ID# 227667 Bilbao Vizcaya Spain 48013
204 Hospital Universitario A Coruna - CHUAC /ID# 227419 A Coruna Spain 15006
205 Hospital Universitario Fundacion Jimenez Diaz /ID# 234115 Madrid Spain 28040
206 Hospital Universitario 12 de Octubre /ID# 227743 Madrid Spain 28041
207 Hospital Universitario Virgen de Valme /ID# 227417 Sevilla Spain 41014
208 Hospital Universitario y Politecnico La Fe /ID# 227408 Valencia Spain 46026
209 Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220 Chia-Yi Taiwan 62247
210 Far Eastern Memorial Hospital /ID# 227373 New Taipei City Taiwan 22060
211 National Taiwan University Hospital /ID# 230001 Taipei City Taiwan 100
212 Taipei Veterans General Hosp /ID# 227376 Taipei City Taiwan 11217
213 Hacettepe Universitesi Tip Fak /ID# 227796 Sihhiye Ankara Turkey 06100
214 Ankara Univ Medical Faculty /ID# 227797 Ankara Turkey 06590
215 Kocaeli University Med Faculty /ID# 228244 Kocaeli Turkey 41380
216 MNI City Multidisciplinary Hospital #18 /ID# 228961 Kharkiv Ukraine 61110
217 Khmelnytskyi Regional Hospital /ID# 230680 Khmelnytskyi Ukraine 29000
218 Medical Center of Medical Clinic Blagomed LLC /ID# 228956 Kyiv Ukraine 01023
219 Medical Center "OK!Clinic+" /ID# 228958 Kyiv Ukraine 02091
220 Medical Center CONSILIUM MEDICAL /ID# 228959 Kyiv Ukraine 04050
221 PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 228962 Poltava Ukraine 36011
222 CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954 Vinnytsia Ukraine 21028
223 Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 228955 Vinnytsia Ukraine 21029

Sponsors and Collaborators

  • AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT04888585
Other Study ID Numbers:
  • M20-466
  • 2020-005303-39
First Posted:
May 17, 2021
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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.:
No
Keywords provided by AbbVie
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022