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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04888585




Registration number
NCT04888585
Ethics application status
Date submitted
13/05/2021
Date registered
17/05/2021
Date last updated
14/08/2023

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

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2021
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
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Ukraine
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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 evaluates how safe and effective ABBV-154 is
in participants treated for moderately to severely active RA. Adverse events and change in
the disease activity will be assessed.

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

The study is 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 will be re-randomized to receive ABBV-154 in 2 different doses SC every other week
(eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154.

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/ct2/show/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/ct2/show/NCT04888585