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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/NCT02675426
Registration number
NCT02675426
Ethics application status
Date submitted
11/12/2015
Date registered
5/02/2016
Date last updated
11/04/2023
Titles & IDs
Public title
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
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Scientific title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
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Secondary ID [1]
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2015-003332-13
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Secondary ID [2]
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M13-549
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Universal Trial Number (UTN)
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Trial acronym
SELECT-NEXT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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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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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Upadacitinib
Experimental: Upadacitinib 15 mg - Period 1: Participants receive upadacitinib 15 mg once daily for 12 weeks.
Period 2: Participants continue to receive upadacitinib 15 mg once daily for an additional 248 weeks.
Experimental: Upadacitinib 30 mg - Period 1: Participants receive upadacitinib 30 mg once daily for 12 weeks.
Period 2: Participants continue to receive upadacitinib 30 mg once daily for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Experimental: Placebo / Upadacitinib 15 mg - Period 1: Participants receive placebo once daily for 12 weeks.
Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.
Experimental: Placebo / Upadacitinib 30 mg - Period 1: Participants receive placebo once daily for 12 weeks.
Period 2: Participants receive upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
Treatment: Drugs: Placebo
Tablet; Oral
Treatment: Drugs: Upadacitinib
Tablet; Oral
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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 With an American College of Rheumatology 20% (ACR20) Response at Week 12
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Assessment method [1]
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The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) 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 global assessment of disease activity;
Patient global assessment of disease activity;
Patient assessment of pain;
Health Assessment Questionnaire - Disability Index (HAQ-DI);
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [1]
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Baseline and Week 12
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Primary outcome [2]
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Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
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Assessment method [2]
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The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of = 3.2 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than or equal to 3.2 indicates low disease activity.
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Timepoint [2]
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Week 12
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Secondary outcome [1]
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Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12
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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 (0-100), 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.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
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Assessment method [2]
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The Health Assessment Questionnaire - Disability Index is a patient-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 [2]
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Baseline and Week 12
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Secondary outcome [3]
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Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score at Week 12
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Assessment method [3]
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The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component summary score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12
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Assessment method [4]
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Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.
DAS28 (CRP) 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 (0-100), 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 [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12
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Assessment method [5]
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Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score = 10.
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 global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Change From Baseline in Duration of Morning Stiffness at Week 12
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Assessment method [6]
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Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days.
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
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Assessment method [7]
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The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a five point Likert scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.
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Timepoint [7]
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Baseline and week 12
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Secondary outcome [8]
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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
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Assessment method [8]
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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 global assessment of disease activity;
Patient global assessment of disease activity;
Patient assessment of pain;
Health Assessment Questionnaire - Disability Index (HAQ-DI);
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
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Assessment method [9]
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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 global assessment of disease activity;
Patient global assessment of disease activity;
Patient assessment of pain;
Health Assessment Questionnaire - Disability Index (HAQ-DI);
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [9]
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Baseline and Week 12
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Secondary outcome [10]
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
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Assessment method [10]
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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 global assessment of disease activity;
Patient global assessment of disease activity;
Patient assessment of pain;
Health Assessment Questionnaire - Disability Index (HAQ-DI);
High-sensitivity C-reactive protein (hsCRP).
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Timepoint [10]
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Baseline and Week 1
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Eligibility
Key inclusion criteria
- Adult male or female, at least 18 years old.
- Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.
- Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for
greater than or equal to 3 months and on a stable dose for greater than or equal to 4
weeks prior to the first dose of study drug. The following csDMARDs are allowed:
methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
- Meets the following minimum disease activity criteria: greater than or equal to 6
swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints
(based on 68 joint counts) at Screening and Baseline Visits.
- Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled
(up to 20% of study population) if they have documented evidence of intolerance to
bDMARDs or limited exposure (less than 3 months) and have satisfied required washout
periods.
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Minimum age
18
Years
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Maximum age
No limit
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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
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).
- History of inflammatory joint disease other than RA. History of secondary Sjogren's
Syndrome is permitted.
- Subjects who are considered inadequate responders to bDMARD therapy as determined by
the Investigator.
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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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
17/12/2015
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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
10/03/2022
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Sample size
Target
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Accrual to date
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Final
661
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Coffs Clinical Trials /ID# 138747 - Coffs Harbour
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Recruitment hospital [2]
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Optimus Clinical Research Pty. /ID# 138769 - Kogarah
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Recruitment hospital [3]
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Emeritus Research /ID# 138773 - Camberwell
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Recruitment hospital [4]
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Barwon Rheumatology /ID# 138772 - Geelong
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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3124 - Camberwell
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment outside Australia
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United Kingdom
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Warrington
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Funding & Sponsors
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Commercial sector/Industry
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Name
AbbVie
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Summary
Brief summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of
upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and
symptoms of adults with moderately to severely active rheumatoid arthritis who were on a
stable dose of csDMARDs and had an inadequate response to csDMARDs.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02675426
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Trial related presentations / publications
Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
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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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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02675426
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