Study to Evaluate Adverse Events and Change in Disease Ac... | NCT04888585 | Trialant
NCT04888585
Sponsor
AbbVie
Status
Terminated
Last Update Posted
Oct 8, 2024Actual
Enrollment
473Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis (RA)
Interventions
ABBV-154
Placebo
Countries
United States
Australia
Canada
Czechia
Germany
Greece
Hungary
Israel
Italy
Japan
Netherlands
New Zealand
Poland
Puerto Rico
Russia
Slovakia
South Korea
Spain
Taiwan
Turkey (Türkiye)
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04888585
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M20-466
Secondary IDs
ID
Type
Description
Link
2020-005303-39
EudraCT Number
Brief Title
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)
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)
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business decision
Expanded Access Info
No
Start Date
Jun 23, 2021Actual
Primary Completion Date
Aug 25, 2022Actual
Completion Date
Aug 4, 2023Actual
First Submitted Date
May 13, 2021
First Submission Date that Met QC Criteria
May 13, 2021
First Posted Date
May 17, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 19, 2024
Results First Submitted that Met QC Criteria
Sep 30, 2024
Results First Posted Date
Oct 8, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 14, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 8, 2024Actual
Last Update Submitted Date
Sep 30, 2024
Last Update Posted Date
Oct 8, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluated how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity were assessed.
ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors placed the participants in 1 of 5 treatment groups or arms; each arm received a different treatment. There was a 1 in 5 chance that participants were assigned to placebo. Participants 18-75 years of age with moderate to severe RA were enrolled. Around 425 participants were to be enrolled in the study at approximately 270 sites worldwide.
The study was comprised 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 were re-randomized to receive ABBV-154 at 1 of 2 different doses SC every other week (EOW). Other participants remained on their previous dose and dosing regimen of ABBV-154.
There may have been a higher treatment burden for participants in this trial compared to their standard of care. Participants attended regular visits during the study at a hospital or clinic. The effect of the treatment was checked by medical assessments, blood tests, and side effects, and completing questionnaires.
Detailed Description
Participants were randomly assigned at a ratio of 1:1:1:1:1 to ABBV-154 at either 40 mg, 150 mg, 340 mg, subcutaneously (SC) EOW; 340 mg SC every 4 weeks (E4W); or placebo SC EOW. Randomization was stratified by baseline glucocorticoid (yes/no); number of prior failed biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) (1; 2 or more); and prior anti-TNF failure (yes/no) and if yes, further stratification by prior adalimumab use (yes/no).
After 12 weeks, participants receiving placebo were re-randomized to receive ABBV-154 150 mg SC EOW or 340 mg SC EOW for the long-term extension (LTE) periods. At re-randomization, participants were stratified by baseline glucocorticoid use (yes/no) and prior adalimumab use (yes/no). Participants from the other dose groups were to continue with their respective dose and dosing regimen.
The primary analysis was conducted after all ongoing participants completed Week 12 or withdrew from the study. A final analysis was to be conducted after all participants completed LTE period 2 and a safety follow-up visit or withdrew from the study. The study was terminated before any participants entered LTE Period 2.
Conditions Module
Conditions
Rheumatoid Arthritis (RA)
Keywords
Rheumatoid Arthritis (RA)
ABBV-154
AIM-RA
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
473Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose A of ABBV-154
Experimental
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
Dose B of ABBV-154
Experimental
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
Dose C of ABBV-154 EOW
Experimental
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
Dose C of ABBV-154 E4W
Experimental
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
Placebo
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ABBV-154
Drug
Subcutaneous Injection
Dose A of ABBV-154
Dose B of ABBV-154
Dose C of ABBV-154 E4W
Dose C of ABBV-154 EOW
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12
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 (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).
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12
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. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Elite Clinical Studies, LLC /ID# 228227
Phoenix
Arizona
85018
United States
Arthritis and Rheumatism Associates /ID# 228201
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
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.
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/
The ITT Population included all participants who were randomized and received at least 1 dose of study drug. One randomized participant (ABBV-154 150 mg EOW) was not treated and thus not included in the ITT population (N=472).
Recruitment Details
A total of 473 participants (All Randomized Population) were enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
Change in Clinical Disease Activity Index (CDAI) at Week 12
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.
Baseline to Week 12
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
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).
Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
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).
Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12
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.
Week 12
Percentage of Participants Achieving LDA Defined by CDAI <= 10 at Week 12
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.
Week 12
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12
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.
Week 12
Percentage of Participants Achieving CR Defined by CDAI <= 2.8 at Week 12
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.
Week 12
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12
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.
Baseline to Week 12
Jonesboro
Arkansas
72401-6251
United States
Providence Medical Foundation /ID# 228104
Fullerton
California
92835
United States
Care Access Research, Huntington Beach /ID# 228163
Huntington Beach
California
92648
United States
Purushotham & Akther Kotha MD, Inc /ID# 228120
La Mesa
California
91942
United States
Arthritis & Osteo Medical Ctr /ID# 228239
La Palma
California
90623-1728
United States
Pacific Arthritis Care Center - Los Angeles /ID# 229330
Los Angeles
California
90045-6200
United States
California Medical Research Associates /ID# 230131
Northridge
California
91324
United States
Arthritis Care And Research Center ACRC /ID# 230099
Poway
California
92064
United States
East Bay Rheumatology Medical /ID# 228099
San Leandro
California
94578
United States
Millennium Clinical Trials /ID# 230618
Thousand Oaks
California
91360-3951
United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241
Torrance
California
90502
United States
Medvin Clinical Research /ID# 228181
Tujunga
California
91042-2706
United States
Inland Rheum & Osteo Med Grp /ID# 228204
Upland
California
91786
United States
Comprehensive Rheumatology Center /ID# 230132
Woodland Hills
California
91364
United States
Denver Arthritis Clinic /ID# 228172
Denver
Colorado
80230
United States
New England Research Associates, LLC /ID# 230127
Bridgeport
Connecticut
06606-1827
United States
Stamford Therapeutics Consorti /ID# 229214
Stamford
Connecticut
06905
United States
Delaware Arthritis /ID# 229413
Lewes
Delaware
19958
United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229
Boca Raton
Florida
33486
United States
Bay Area Arthritis and Osteo /ID# 228075
Brandon
Florida
33511
United States
Clinical Research of West Florida, Inc /ID# 228128
Clearwater
Florida
33765
United States
International Medical Research /ID# 228069
Daytona Beach
Florida
32117
United States
Omega Research Debary, LLC /ID# 228293
DeBary
Florida
32713-2260
United States
Neoclinical Research /ID# 228753
Hialeah
Florida
33016-1897
United States
University of Florida /ID# 228242
Jacksonville
Florida
32209
United States
Lakes Research, LLC /ID# 228665
Miami
Florida
33014
United States
University of Miami /ID# 228737
Miami
Florida
33136
United States
Suncoast Clinical Research /ID# 228237
New Port Richey
Florida
34652
United States
Omega Research Group /ID# 229966
Orlando
Florida
32808
United States
HMD Research LLC /ID# 228185
Orlando
Florida
32819
United States
Millennium Research /ID# 228183
Ormond Beach
Florida
32174
United States
Arthritis Center, Inc. /ID# 228209
Palm Harbor
Florida
34684
United States
BayCare Medical Group /ID# 228289
St. Petersburg
Florida
33705
United States
West Broward Rheumatology Associates /ID# 228603
Tamarac
Florida
33321
United States
Clinical Research of West Florida - Tampa /ID# 228186
Tampa
Florida
33606-1246
United States
Conquest Research /ID# 230560
Winter Park
Florida
32789
United States
Florida Medical Clinic /ID# 228236
Zephyrhills
Florida
33542
United States
Arthritis and Rheumatology /ID# 228743
Atlanta
Georgia
30342
United States
Jefrey D. Lieberman, MD, P.C. /ID# 230129
Decatur
Georgia
30033
United States
Arthritis Center of North GA /ID# 228769
Gainesville
Georgia
30501
United States
Atlanta Research Center for Rheumatology /ID# 230430
Marietta
Georgia
20060
United States
Great Lakes Clinical Trials /ID# 228699
Chicago
Illinois
60640
United States
Greater Chicago Specialty Physicians /ID# 228282
Schaumburg
Illinois
60195-3106
United States
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174
Skokie
Illinois
60076
United States
Springfield Clinic /ID# 228124
Springfield
Illinois
62702-3749
United States
Beacon Medical Group Clinical Research /ID# 229153
Granger
Indiana
46530
United States
University of Iowa Hospitals and Clinics /ID# 229217
Iowa City
Iowa
52242
United States
Four Rivers Clinical Research /ID# 230109
Paducah
Kentucky
42001
United States
The Arthritis & Diabetes Clinic, Inc. /ID# 228221
Monroe
Louisiana
71203
United States
Klein and Associates MD /ID# 230145
Cumberland
Maryland
21502
United States
Klein and Associates MD - Hagerstown /ID# 230143
Hagerstown
Maryland
21742
United States
The Center for Rheumatology and Bone Research /ID# 228617
Wheaton
Maryland
20902
United States
AA Medical Research Center - Grand Blanc /ID# 228604
Grand Blanc
Michigan
48439
United States
Advanced Rheumatology, PC /ID# 228684
Lansing
Michigan
48910
United States
June DO, PC /ID# 229838
Lansing
Michigan
48911
United States
Arthritis Associates /ID# 230188
Hattiesburg
Mississippi
39402
United States
Rheumatology Consultants - Clinical Research /ID# 229208
Tupelo
Mississippi
38801-4949
United States
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283
St Louis
Missouri
63119-3845
United States
West County Rheumatology /ID# 228102
St Louis
Missouri
63131-1703
United States
Logan Health Research /ID# 228273
Kalispell
Montana
59901
United States
Advanced Biomedical Research of America /ID# 228596
Las Vegas
Nevada
89123
United States
Innovative Health Research /ID# 229209
Las Vegas
Nevada
89128
United States
Arthritis and Osteoporosis Associates /ID# 229418
Freehold
New Jersey
07728-8307
United States
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602
Voorhees Township
New Jersey
08043
United States
Albuquerque Center For Rheumatology /ID# 228709
Albuquerque
New Mexico
87102
United States
Albuquerque Clinical Trials, Inc /ID# 228925
Albuquerque
New Mexico
87102
United States
Arthritis and Osteo Assoc /ID# 228662
Las Cruces
New Mexico
88011
United States
Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710
Orchard Park
New York
14127
United States
St. Lawrence Health System /ID# 229508
Potsdam
New York
13676
United States
DJL Clinical Research, PLLC /ID# 230133
Charlotte
North Carolina
28211
United States
Cape Fear Arthritis Care /ID# 228747
Leland
North Carolina
28451
United States
PMG Research of Salisbury /ID# 230627
Salisbury
North Carolina
28144
United States
Trinity Health Med Arts Clinic /ID# 228202
Minot
North Dakota
58701
United States
University of Cincinnati /ID# 229212
Cincinnati
Ohio
45267-0585
United States
Paramount Medical Research Con /ID# 228254
Middleburg Heights
Ohio
44130
United States
Arthritis Assoc of NW Ohio /ID# 228936
Toledo
Ohio
43606
United States
Arthritis and Rheumatology Center of Oklahoma /ID# 228975
Oklahoma City
Oklahoma
73102
United States
Rheumatology Associates of Oklahoma /ID# 228701
Oklahoma City
Oklahoma
73116-7226
United States
Advanced Rheumatology & Arthritis Wellness Center /ID# 228608
Cranberry Township
Pennsylvania
16066
United States
Altoona Ctr Clinical Res /ID# 230058
Duncansville
Pennsylvania
16635
United States
Arthritis Group /ID# 229777
Philadelphia
Pennsylvania
19152
United States
PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742
Wyomissing
Pennsylvania
19610
United States
Columbia Arthritis Center /ID# 228705
Columbia
South Carolina
29204
United States
West Tennessee Research Institute /ID# 228257
Jackson
Tennessee
38305
United States
Arthritis and Rheumatology Research Institute, PLLC /ID# 228937
Allen
Texas
75013-6147
United States
Allen Arthritis /ID# 228712
Allen
Texas
75013
United States
Trinity Universal Research Associates - Carrollton /ID# 230104
Carrollton
Texas
75007
United States
Adriana Pop-Moody MD Clinic PA /ID# 230062
Corpus Christi
Texas
78404
United States
West Texas Clinical Research /ID# 228276
Lubbock
Texas
79424
United States
P&I Clinical Research /ID# 230183
Lufkin
Texas
75904-3132
United States
SW Rheumatology Res. LLC /ID# 228088
Mesquite
Texas
75150
United States
Trinity Universal Research Associates, Inc /ID# 228238
Plano
Texas
75024-5283
United States
Epic Medical Research /ID# 228097
Red Oak
Texas
75154-3981
United States
Sun Research Institute /ID# 228768
San Antonio
Texas
78215
United States
Advanced Rheumatology of Houston /ID# 228170
The Woodlands
Texas
77382
United States
DM Clinical Research - Tomball /ID# 228112
Tomball
Texas
77375
United States
Rheumatology Clinic of Houston /ID# 228178
Tomball
Texas
77377
United States
Arthritis & Osteoporosis Clinic /ID# 228736
Waco
Texas
76710
United States
Tidewater Physicians Medical Center /ID# 230130
Newport News
Virginia
23606-4434
United States
Arthritis Northwest, PLLC /ID# 228275
Spokane
Washington
99204-2302
United States
Emeritus Research Sydney /ID# 230070
Botany
New South Wales
2019
Australia
BJC Health /ID# 229015
Parramatta
New South Wales
2150
Australia
Rheumatology Research Unit Sunshine Coast /ID# 229017
Maroochydore
Queensland
4558
Australia
The Queen Elizabeth Hospital /ID# 230071
Woodville South
South Australia
5011
Australia
Emeritus Research /ID# 229018
Camberwell
Victoria
3124
Australia
Rheumatology Research Associates /ID# 227818
Edmonton
Alberta
T5M 0H4
Canada
Manitoba Clinic /ID# 227822
Winnipeg
Manitoba
R3A 1M3
Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 227821
Sainte-Foy
Quebec
G1V 3M7
Canada
Centre de Recherche Musculo-Squelettique /ID# 227824
Trois-Rivières
Quebec
G8Z 1Y2
Canada
Dr Naik-Medical Professional Corporation-Alliance Health /ID# 227823
Hospital Regional Universitario de Malaga /ID# 227418
Málaga
29011
Spain
Hospital Universitario Virgen de Valme /ID# 227417
Seville
41014
Spain
Hospital Universitario y Politecnico La Fe /ID# 227408
Valencia
46026
Spain
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220
Chiayi City
62247
Taiwan
Far Eastern Memorial Hospital /ID# 227373
New Taipei City
22060
Taiwan
National Taiwan University Hospital /ID# 230001
Taipei
100
Taiwan
Taipei Veterans General Hosp /ID# 227376
Taipei
11217
Taiwan
Hacettepe Universitesi Tip Fak /ID# 227796
Sihhiye
Ankara
06100
Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 227797
Ankara
06590
Turkey (Türkiye)
Kocaeli University Med Faculty /ID# 228244
Kocaeli
41380
Turkey (Türkiye)
MNI City Multidisciplinary Hospital #18 Kharkiv City Council /ID# 228961
Kharkiv
61029
Ukraine
Khmelnytskyi Regional Hospital /ID# 230680
Khmelnytskyi
29000
Ukraine
Medical Center of Medical Clinic Blagomed LLC /ID# 228956
Kyiv
01023
Ukraine
Medical Center "OK! Clinic+" LLC, "International Institute of Clinical Research" /ID# 228958
Kyiv
02091
Ukraine
Medical Center CONSILIUM MEDICAL /ID# 228959
Kyiv
04050
Ukraine
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky of PCC" /ID# 228962
Poltava
36011
Ukraine
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954
Vinnytsia
21018
Ukraine
Сlinic Scientific Research Inst of Invalid Rehab ESMС M I Pyrogov VNMU /ID# 228955
Vinnytsia
21029
Ukraine
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG005
Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the LTE period.
FG006
Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
Participants in this group received placebo SC eow for 12 weeks in the placebo-controlled period and were re-randomized in 1:1 ratio to receive ABBV-154 150 mg or 340 mg respectively SC EOW for 66 weeks in the LTE period.
FG007
Period 2 (Extension Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG008
Period 2 (Extension Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG009
Period 2 (Extension Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG010
Period 2 (Extension Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC E4W for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
FG00096 subjects
FG00198 subjects
FG00295 subjectsOne randomized participant was ineligible and did not receive treatment. This participant was was not included in the ITT population.
FG00390 subjects
FG00494 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG00092 subjects
FG00193 subjects
FG00286 subjects
FG00385 subjects
FG00489 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0029 subjects
FG0035 subjects
FG0045 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Other
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0032 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Long Term Extension (Wk 13-End of Study)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00545 subjectsOne participant from Period 1 Placebo group did not enter Period 2.
FG00646 subjects
FG00793 subjects
FG00886 subjects
FG00985 subjects
FG01089 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Intent-to-treat (ITT) Population included all participants who were randomized and received at least 1 dose of study drug (N=472). The ITT Population was used for all efficacy analyses.
The Placebo group from Period 1 was re-randomized to either 150 mg or 340 mg for the Long-Term Extension Periods 1 and 2. For the other groups from Period 1 receiving ABBV-154, participants continued receiving ABBV-154 at the same dose and dosing regimen as in Period 1.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
BG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
BG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
BG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
BG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00096
BG00198
BG00294
BG00390
BG00494
BG005472
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00057.8± 11.28
BG00156.2± 10.17
BG00256.8± 9.91
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00080
BG00176
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00017
BG00118
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12
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 (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).
ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00096
OG00198
OG00294
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.3(1.4 to 11.1)
OG00125.5(16.9 to 34.1)
OG00233.3(23.7 to 42.9)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12
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. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
ITT analysis set participants with non-missing baseline and at least one post-baseline value were included; all observed data up to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline to Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG002
Secondary
Change in Clinical Disease Activity Index (CDAI) at Week 12
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.
Intent-to-treat analysis set participants with non-missing baseline and at least one post-baseline value were included; all observed data up to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline to Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
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).
ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
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).
ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Secondary
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12
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.
ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Secondary
Percentage of Participants Achieving LDA Defined by CDAI <= 10 at Week 12
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.
ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Secondary
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12
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.
ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Secondary
Percentage of Participants Achieving CR Defined by CDAI <= 2.8 at Week 12
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.
ITT analysis set participants were included (N=472); Participants with missing Week 12 data for reasons other than COVID-19 or logistical restrictions were counted as non-responders (non-responder imputation), unless they were a responder before and after Week 12 (responder imputation); participants with missing Week 12 data because of COVID-19 or logistical restrictions were handled by multiple imputation.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Secondary
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12
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.
Intent-to-treat analysis set participants with non-missing baseline and at least one post-baseline value were included; all observed data up to Week 12 was used.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline to Week 12
ID
Title
Description
OG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
OG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Time Frame
All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time participants were followed was 85 days for all groups in Period 1. For each LTE group, the median time participants were followed was 412 days (Placebo-ABBV-154 150 mg EOW); 389 days (Placebo-ABBV-154 340 mg EOW); 390 days (ABBV-154 40 mg EOW); 402.5 days (ABBV-154 150 mg EOW), 404 days (ABBV-154 340 mg EOW), and 380 days (ABBV-154 340 mg E4W), respectively.
Description
All Randomized Population (N=473)
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Period 1 (Placebo-Controlled Period) Placebo
Participants in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
0
96
2
96
25
96
EG001
Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
0
98
4
98
43
98
EG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
0
95
6
95
26
95
EG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
0
90
5
90
26
90
EG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
0
94
3
94
27
94
EG005
Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 150mg SC EOW for 66 weeks in the LTE period.
0
45
3
45
31
45
EG006
Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
Participants in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 340mg SC EOW for 66 weeks in the LTE period.
0
46
6
46
25
46
EG007
Period 2 (Extension Period) ABBV-154 40 mg EOW
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
1
91
7
91
54
91
EG008
Period 2 (Extension Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
0
86
8
86
56
86
EG009
Period 2 (Extension Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
0
84
10
84
52
84
EG010
Period 2 (Extension Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC E4W for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
3
89
9
89
47
89
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ACUTE CORONARY SYNDROME
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected94 at risk
EG0050 events0 affected45 at risk
EG0060 events0 affected46 at risk
EG0070 events0 affected91 at risk
EG0080 events0 affected86 at risk
EG0090 events0 affected84 at risk
EG0101 events1 affected89 at risk
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
BRADYCARDIA
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
CARDIAC FAILURE CONGESTIVE
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected95 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
FOOD POISONING
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
INCARCERATED INGUINAL HERNIA
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
LARGE INTESTINE POLYP
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
MULTIPLE ORGAN DYSFUNCTION SYNDROME
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
CHOLANGITIS ACUTE
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
ANAPHYLACTIC REACTION
Immune system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
BACTERAEMIA
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected95 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected95 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
INFECTIOUS MONONUCLEOSIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
NEUROLOGICAL INFECTION
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
OPPORTUNISTIC INFECTION
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
OSTEOMYELITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
POSTOPERATIVE WOUND INFECTION
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
Q FEVER
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SEPSIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
WOUND INFECTION STAPHYLOCOCCAL
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
PATELLA FRACTURE
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SPINAL COMPRESSION FRACTURE
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SYNOVIAL RUPTURE
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0022 events1 affected95 at risk
EG003
TENDON INJURY
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected95 at risk
EG003
EXOSTOSIS
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SYNOVIAL CYST
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SYNOVITIS
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
TENOSYNOVITIS
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
ADENOCARCINOMA OF COLON
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
GLIOBLASTOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
HEPATOCELLULAR CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
CEREBRAL ISCHAEMIA
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
METABOLIC ENCEPHALOPATHY
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
STROKE IN EVOLUTION
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
SUBARACHNOID HAEMORRHAGE
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
UTERINE POLYP
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
AORTIC STENOSIS
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DIARRHOEA
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected96 at risk
EG0012 events2 affected98 at risk
EG0025 events3 affected95 at risk
EG0032 events2 affected90 at risk
EG0040 events0 affected94 at risk
EG0052 events2 affected45 at risk
EG0060 events0 affected46 at risk
EG0074 events3 affected91 at risk
EG0086 events5 affected86 at risk
EG0092 events2 affected84 at risk
EG0102 events2 affected89 at risk
NAUSEA
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
INJECTION SITE BRUISING
General disorders
MedDRA (26.0)
Systematic Assessment
EG0002 events2 affected96 at risk
EG0014 events3 affected98 at risk
EG0020 events0 affected95 at risk
EG003
INJECTION SITE DISCOLOURATION
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0014 events3 affected98 at risk
EG0022 events1 affected95 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
MedDRA (26.0)
Systematic Assessment
EG0003 events1 affected96 at risk
EG0017 events3 affected98 at risk
EG0021 events1 affected95 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
PYREXIA
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected95 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0002 events2 affected96 at risk
EG0012 events2 affected98 at risk
EG0021 events1 affected95 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected96 at risk
EG00113 events13 affected98 at risk
EG0025 events5 affected95 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected95 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0002 events2 affected96 at risk
EG0012 events2 affected98 at risk
EG0025 events4 affected95 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected95 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected96 at risk
EG0013 events3 affected98 at risk
EG0020 events0 affected95 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0003 events3 affected96 at risk
EG0015 events5 affected98 at risk
EG0021 events1 affected95 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0023 events3 affected95 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected96 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected95 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0012 events2 affected98 at risk
EG0021 events1 affected95 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0002 events2 affected96 at risk
EG0014 events3 affected98 at risk
EG0020 events0 affected95 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0008 events7 affected96 at risk
EG0016 events5 affected98 at risk
EG0022 events2 affected95 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0003 events3 affected96 at risk
EG0014 events4 affected98 at risk
EG0023 events3 affected95 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0012 events2 affected98 at risk
EG0025 events3 affected95 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected96 at risk
EG0010 events0 affected98 at risk
EG0022 events2 affected95 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00093
OG00195
OG00290
OG00386
OG00494
Title
Denominators
Categories
Title
Measurements
OG000-1.08(-1.35 to -0.82)
OG001-1.59(-1.85 to -1.33)
OG002-2.09(-2.37 to -1.82)
OG003-2.51(-2.78 to -2.23)
OG004-1.71(-1.96 to -1.45)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
MMRM includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00092
OG00191
OG00288
OG00386
OG00493
Title
Denominators
Categories
Title
Measurements
OG000-14.21(-16.81 to -11.60)
OG001-18.77(-21.41 to -16.13)
OG002-22.21(-24.94 to -19.48)
OG003-25.62(-28.31 to -22.93)
OG004-19.50(-22.06 to -16.94)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00096
OG00198
OG00294
OG00390
OG00494
Title
Denominators
Categories
Title
Measurements
OG00028.1(19.1 to 37.1)
OG00152.7(42.7 to 62.7)
OG00259.3(49.3 to 69.2)
OG00374.4(65.4 to 83.5)
OG00454.3(44.2 to 64.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00096
OG00198
OG00294
OG00390
OG00494
Title
Denominators
Categories
Title
Measurements
OG0003.1(0.0 to 6.6)
OG0019.2(3.5 to 14.9)
OG00212.8(6.1 to 19.6)
OG00313.3(6.3 to 20.4)
OG0044.3(0.2 to 8.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
Participants in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG002
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00096
OG00198
OG00294
OG00390
OG00494
Title
Denominators
Categories
Title
Measurements
OG00020.8(12.7 to 29.0)
OG00138.9(29.2 to 48.6)
OG00248.2(38.0 to 58.3)
OG00353.3(43.0 to 63.6)
OG00445.7(35.7 to 55.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00096
OG00198
OG00294
OG00390
OG00494
Title
Denominators
Categories
Title
Measurements
OG00021.9(13.6 to 30.1)
OG00136.8(27.3 to 46.4)
OG00246.1(36.0 to 56.2)
OG00346.7(36.4 to 57.0)
OG00436.2(26.5 to 45.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00096
OG00198
OG00294
OG00390
OG00494
Title
Denominators
Categories
Title
Measurements
OG00012.5(5.9 to 19.1)
OG00118.4(10.7 to 26.1)
OG00233.0(23.5 to 42.6)
OG00337.8(27.8 to 47.8)
OG00427.7(18.6 to 36.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00096
OG00198
OG00294
OG00390
OG00494
Title
Denominators
Categories
Title
Measurements
OG0002.1(0.0 to 4.9)
OG0019.2(3.5 to 14.9)
OG0024.3(0.2 to 8.3)
OG0034.4(0.2 to 8.7)
OG0043.2(0.0 to 6.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
Participants in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG003
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
Participants in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
OG004
Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
Participants in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
Units
Counts
Participants
OG00094
OG00195
OG00290
OG00386
OG00494
Title
Denominators
Categories
Title
Measurements
OG000-0.08(-0.19 to 0.03)
OG001-0.26(-0.36 to -0.15)
OG002-0.33(-0.45 to -0.22)
OG003-0.41(-0.52 to -0.29)
OG004-0.29(-0.39 to -0.18)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
0.022
Least Squares (LS) Mean Difference
-0.18
2-Sided
95
-0.33
-0.03
ABBV-154 40mg EOW - Placebo
Superiority
OG000
OG002
Mixed Models Analysis
MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.