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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
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)
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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)
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Secondary ID [1]
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2020-005303-39
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Secondary ID [2]
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M20-466
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA)
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
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Assessment method [1]
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Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:
1. = 50% improvement in 68-tender joint count;
2. = 50% improvement in 66-swollen joint count; and
3. = 50% improvement in at least 3 of the 5 following parameters:
* Physician's Global Assessment of Disease Activity measured on a Numerical Rating Scale of 0 to 10 (NRS)
* Patient's Global Assessment of Disease Activity (NRS)
* Patient's Assessment of Pain (NRS)
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
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Timepoint [1]
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At 12 weeks
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Secondary outcome [1]
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Change in Disease Activity Score (DAS) 28 (CRP) from Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 12 weeks
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Secondary outcome [2]
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Change in Clinical Disease Activity Index (CDAI) from Baseline
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 12 weeks
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Secondary outcome [3]
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Percentage of Participants Achieving American College of Rheumatology 20 % (ACR20) Response
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Assessment method [3]
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Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
1. = 20% improvement in 68-tender joint count;
2. = 20% improvement in 66-swollen joint count; and
3. = 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).
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Timepoint [3]
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At 12 weeks
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Secondary outcome [4]
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Percentage of Participants Achieving American College of Rheumatology 70 % (ACR70) Response
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Assessment method [4]
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Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
1. = 70% improvement in 68-tender joint count;
2. = 70% improvement in 66-swollen joint count; and
3. = 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).
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Timepoint [4]
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At 12 weeks
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Secondary outcome [5]
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Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2
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Assessment method [5]
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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.
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Timepoint [5]
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At 12 weeks
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Secondary outcome [6]
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Percentage of Participants Achieving LDA Defined by CDAI <= 10
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Assessment method [6]
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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.
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Timepoint [6]
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At 12 weeks
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Secondary outcome [7]
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Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6
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Assessment method [7]
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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.
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Timepoint [7]
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At 12 weeks
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Secondary outcome [8]
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Percentage of Participants Achieving CR Defined by CDAI <= 2.8
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Assessment method [8]
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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.
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Timepoint [8]
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At 12 weeks
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Secondary outcome [9]
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Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline
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Assessment method [9]
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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.
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Timepoint [9]
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Up to 12 weeks
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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).
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/08/2023
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Sample size
Target
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Accrual to date
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Final
473
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Emeritus Research Sydney /ID# 230070 - Botany
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Recruitment hospital [2]
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BJC Health /ID# 229015 - Paramatta
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Recruitment hospital [3]
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Rheumatology Research Unit Sunshine Coast /ID# 229017 - Maroochydore
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Recruitment hospital [4]
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The Queen Elizabeth Hospital /ID# 230071 - Woodville South
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Recruitment hospital [5]
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Emeritus Research /ID# 229018 - Camberwell
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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2150 - Paramatta
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Recruitment postcode(s) [3]
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4558 - Maroochydore
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Recruitment postcode(s) [4]
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5011 - Woodville South
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Recruitment postcode(s) [5]
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3124 - Camberwell
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Recruitment outside Australia
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Yamaguchi
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Pomorskie
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Russian Federation
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Moskva
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Russian Federation
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Sverdlovskaya Oblast
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Moscow
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Russian Federation
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Pushkin
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Russian Federation
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St. Petersburg
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Slovakia
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Martin
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Slovakia
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Nove Mesto nad Vahom
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Slovakia
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Piestany
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Slovakia
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Poprad
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Slovakia
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Rimavska Sobota
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Spain
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A Coruna
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Spain
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Barcelona
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Spain
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Malaga
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Spain
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Vizcaya
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Chia-Yi
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Taiwan
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New Taipei City
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Taiwan
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Taipei City
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Turkey
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Ankara
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Turkey
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Kocaeli
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Ukraine
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Kharkiv
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Ukraine
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Khmelnytskyi
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Ukraine
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Kyiv
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Ukraine
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Poltava
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Ukraine
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Vinnytsia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04888585
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
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/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04888585