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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02706847
Registration number
NCT02706847
Ethics application status
Date submitted
18/02/2016
Date registered
11/03/2016
Titles & IDs
Public title
A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
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Scientific title
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
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Secondary ID [1]
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2015-003335-35
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Secondary ID [2]
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M13-542
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Universal Trial Number (UTN)
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Trial acronym
SELECT-BEYOND
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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 24 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Experimental: Upadacitinib 30 mg - Period 1: Participants receive upadacitinib 30 mg once daily for 24 weeks.
Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Placebo comparator: Placebo / Upadacitnib 15 mg - Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 15 mg once daily for 12 weeks.
Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
Placebo comparator: Placebo / Upadacitnib 30 mg - Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 30 mg once daily for 12 weeks.
Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
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:
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 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 mm), 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 mm), 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 Score (PCS) 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 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 With an American College of Rheumatology 50% (ACR50) Response at Week 12
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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 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 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 [4]
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Baseline and Week 12
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Secondary outcome [5]
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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 [5]
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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 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 [5]
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Baseline and Week 12
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Secondary outcome [6]
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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 [6]
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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 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 [6]
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Baseline and week 1
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Eligibility
Key inclusion criteria
* Diagnosis of rheumatoid arthritis (RA) for= 3 months.
* Treated for = 3 months with = 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
* Participant has been receiving csDMARD therapy = 3 months and on a stable dose for = 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
* Meets both of the following criteria:
* = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
* hsCRP = 3mg/L at Screening Visit.
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Minimum age
18
Years
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Maximum age
99
Years
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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 any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]). Current diagnosis of secondary Sjogren's Syndrome is permitted.
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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
15/03/2016
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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
8/02/2022
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Sample size
Target
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Accrual to date
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Final
499
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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The Queen Elizabeth Hospital /ID# 142419 - Woodville
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Recruitment hospital [2]
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Emeritus Research /ID# 142416 - Camberwell
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Recruitment postcode(s) [1]
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5011 - Woodville
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Recruitment postcode(s) [2]
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3124 - Camberwell
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Recruitment outside Australia
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Ankara
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Turkey
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Samsun
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United Kingdom
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London, City Of
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United Kingdom
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Chelmsford
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United Kingdom
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Edinburgh
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United Kingdom
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Ipswich
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United Kingdom
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Portsmouth
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United Kingdom
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Wirral
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Funding & Sponsors
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Commercial sector/industry
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Name
AbbVie
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Ethics approval
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Summary
Brief summary
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
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Trial website
https://clinicaltrials.gov/study/NCT02706847
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Trial related presentations / publications
Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 18. Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20. Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27. Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum In: Ann Rheum Dis. 2021 May;80(5):e83. doi: 10.1136/annrheumdis-2020-218510corr1. Strand V, Schiff M, Tundia N, Friedman A, Meerwein S, Pangan A, Ganguli A, Fuldeore M, Song Y, Pope J. Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8. Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
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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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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 and 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), Analytic code
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When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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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
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/47/NCT02706847/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT02706847/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02706847