Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04888585




Registration number
NCT04888585
Ethics application status
Date submitted
13/05/2021
Date registered
17/05/2021
Date last updated
8/10/2024

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2020-005303-39
Secondary ID [2] 0 0
M20-466
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-154
Treatment: Drugs - Placebo

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.

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.

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.

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.

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.


Treatment: Drugs: ABBV-154
Subcutaneous Injection

Treatment: Drugs: Placebo
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Change in Clinical Disease Activity Index (CDAI) at Week 12
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving LDA Defined by CDAI <= 10 at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Percentage of Participants Achieving CR Defined by CDAI <= 2.8 at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12
Timepoint [9] 0 0
Baseline to Week 12

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/08/2023
Sample size
Target
Accrual to date
Final
473
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 230070 - Botany
Recruitment hospital [2] 0 0
BJC Health /ID# 229015 - Paramatta
Recruitment hospital [3] 0 0
Rheumatology Research Unit Sunshine Coast /ID# 229017 - Maroochydore
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital /ID# 230071 - Woodville South
Recruitment hospital [5] 0 0
Emeritus Research /ID# 229018 - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2150 - Paramatta
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
Manitoba
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Canada
State/province [36] 0 0
Saskatchewan
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha
Country [38] 0 0
Czechia
State/province [38] 0 0
Uherske Hradiste
Country [39] 0 0
Czechia
State/province [39] 0 0
Velke Bilovice
Country [40] 0 0
Germany
State/province [40] 0 0
Nordrhein-Westfalen
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Greece
State/province [43] 0 0
Attiki
Country [44] 0 0
Greece
State/province [44] 0 0
Kriti
Country [45] 0 0
Greece
State/province [45] 0 0
Thessaloniki
Country [46] 0 0
Hungary
State/province [46] 0 0
Hajdu-Bihar
Country [47] 0 0
Hungary
State/province [47] 0 0
Pest
Country [48] 0 0
Hungary
State/province [48] 0 0
Balatonfüred
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Szekesfehervar
Country [51] 0 0
Hungary
State/province [51] 0 0
Veszprém
Country [52] 0 0
Hungary
State/province [52] 0 0
Zalaegerszeg
Country [53] 0 0
Israel
State/province [53] 0 0
H_efa
Country [54] 0 0
Israel
State/province [54] 0 0
HaMerkaz
Country [55] 0 0
Israel
State/province [55] 0 0
Tel-Aviv
Country [56] 0 0
Italy
State/province [56] 0 0
Lazio
Country [57] 0 0
Italy
State/province [57] 0 0
Ancona
Country [58] 0 0
Italy
State/province [58] 0 0
Palermo
Country [59] 0 0
Japan
State/province [59] 0 0
Aichi
Country [60] 0 0
Japan
State/province [60] 0 0
Fukui
Country [61] 0 0
Japan
State/province [61] 0 0
Fukuoka
Country [62] 0 0
Japan
State/province [62] 0 0
Hokkaido
Country [63] 0 0
Japan
State/province [63] 0 0
Hyogo
Country [64] 0 0
Japan
State/province [64] 0 0
Kagawa
Country [65] 0 0
Japan
State/province [65] 0 0
Kochi
Country [66] 0 0
Japan
State/province [66] 0 0
Kumamoto
Country [67] 0 0
Japan
State/province [67] 0 0
Miyazaki
Country [68] 0 0
Japan
State/province [68] 0 0
Nagasaki
Country [69] 0 0
Japan
State/province [69] 0 0
Niigata
Country [70] 0 0
Japan
State/province [70] 0 0
Osaka
Country [71] 0 0
Japan
State/province [71] 0 0
Saitama
Country [72] 0 0
Japan
State/province [72] 0 0
Tokyo
Country [73] 0 0
Japan
State/province [73] 0 0
Yamaguchi
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Chungcheongnamdo
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seoul Teugbyeolsi
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Daegu
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Incheon
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Seoul
Country [79] 0 0
Netherlands
State/province [79] 0 0
Amsterdam
Country [80] 0 0
Netherlands
State/province [80] 0 0
Maastricht
Country [81] 0 0
New Zealand
State/province [81] 0 0
Auckland
Country [82] 0 0
New Zealand
State/province [82] 0 0
Canterbury
Country [83] 0 0
New Zealand
State/province [83] 0 0
Wellington
Country [84] 0 0
Poland
State/province [84] 0 0
Kujawsko-pomorskie
Country [85] 0 0
Poland
State/province [85] 0 0
Lodzkie
Country [86] 0 0
Poland
State/province [86] 0 0
Mazowieckie
Country [87] 0 0
Poland
State/province [87] 0 0
Podkarpackie
Country [88] 0 0
Poland
State/province [88] 0 0
Podlaskie
Country [89] 0 0
Poland
State/province [89] 0 0
Pomorskie
Country [90] 0 0
Poland
State/province [90] 0 0
Warsaw
Country [91] 0 0
Puerto Rico
State/province [91] 0 0
San Juan
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Moskovskaya Oblast
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Moskva
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Sverdlovskaya Oblast
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Tatarstan, Respublika
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Moscow
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Pushkin
Country [98] 0 0
Russian Federation
State/province [98] 0 0
St. Petersburg
Country [99] 0 0
Slovakia
State/province [99] 0 0
Martin
Country [100] 0 0
Slovakia
State/province [100] 0 0
Nove Mesto nad Vahom
Country [101] 0 0
Slovakia
State/province [101] 0 0
Piestany
Country [102] 0 0
Slovakia
State/province [102] 0 0
Poprad
Country [103] 0 0
Slovakia
State/province [103] 0 0
Rimavska Sobota
Country [104] 0 0
Spain
State/province [104] 0 0
A Coruna
Country [105] 0 0
Spain
State/province [105] 0 0
Barcelona
Country [106] 0 0
Spain
State/province [106] 0 0
Vizcaya
Country [107] 0 0
Spain
State/province [107] 0 0
Madrid
Country [108] 0 0
Spain
State/province [108] 0 0
Malaga
Country [109] 0 0
Spain
State/province [109] 0 0
Sevilla
Country [110] 0 0
Spain
State/province [110] 0 0
Valencia
Country [111] 0 0
Taiwan
State/province [111] 0 0
Chia-Yi
Country [112] 0 0
Taiwan
State/province [112] 0 0
New Taipei City
Country [113] 0 0
Taiwan
State/province [113] 0 0
Taipei City
Country [114] 0 0
Taiwan
State/province [114] 0 0
Taipei
Country [115] 0 0
Turkey
State/province [115] 0 0
Ankara
Country [116] 0 0
Turkey
State/province [116] 0 0
Kocaeli
Country [117] 0 0
Ukraine
State/province [117] 0 0
Kharkiv
Country [118] 0 0
Ukraine
State/province [118] 0 0
Khmelnytskyi
Country [119] 0 0
Ukraine
State/province [119] 0 0
Kyiv
Country [120] 0 0
Ukraine
State/province [120] 0 0
Poltava
Country [121] 0 0
Ukraine
State/province [121] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04888585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04888585