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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/NCT03725202
Registration number
NCT03725202
Ethics application status
Date submitted
27/10/2018
Date registered
30/10/2018
Date last updated
23/02/2024
Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA
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Secondary ID [1]
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2023-505476-29-00
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Secondary ID [2]
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M16-852
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Universal Trial Number (UTN)
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Trial acronym
SELECT-GCA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis (GCA)
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Other neurological disorders
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Corticosteroid (CS)
Other interventions - Placebo
Experimental: Arm A - Upadacitinib dose A administered daily + 26-week CS taper regimen
Experimental: Arm B - Upadacitinib dose B administered daily + 26-week CS taper regimen
Placebo Comparator: Arm C - Placebo administered daily + 52-week CS taper regimen
Treatment: Drugs: Upadacitinib
It will be administered orally.
Treatment: Drugs: Corticosteroid (CS)
It will be administered orally.
Other interventions: Placebo
It will be administered orally.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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 Sustained Remission
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Assessment method [1]
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Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen.
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Timepoint [1]
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At Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving Sustained Complete Remission
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Assessment method [1]
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Sustained complete remission is defined as having absence of GCA signs and symptoms; normalization of erythrocyte sedimentation rate (ESR); Normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen.
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Timepoint [1]
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Week 12 through Week 52
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Secondary outcome [2]
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Cumulative Corticosteroid (CS) exposure
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Assessment method [2]
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The cumulative exposure to corticosteroid(s) is assessed.
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Timepoint [2]
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Up to Week 52
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Secondary outcome [3]
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Time to First Disease Flare
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Assessment method [3]
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Disease flare is defined as an event determined by the investigator to represent recurrence of GCA signs or symptoms or an ESR measurement > 30 mm/hr (attributable to GCA) AND requiring an increase in CS dose.
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Timepoint [3]
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Up to Week 52
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Secondary outcome [4]
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Percentage of Participants Who Experience at Least 1 Disease Flare
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Assessment method [4]
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The percentage of participants who experience at least 1 disease flare is assessed
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Timepoint [4]
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Up to Week 52
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Secondary outcome [5]
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Percentage of Participants in Complete Remission
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Assessment method [5]
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Complete remission is defined as having achieved absence of GCA signs and symptoms; normalization of ESR; normalization of hs-CRP and adherence to the protocol-defined CS taper regimen.
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Timepoint [5]
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Up to Week 52
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Secondary outcome [6]
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Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS)
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Assessment method [6]
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The SF-36 is a generic health-related quality-of-life instrument that can be used across age, disease and treatment groups and includes 8 domains: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, pain, energy/fatigue, emotional well-being, and general health problems.
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Timepoint [6]
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At Week 52
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Secondary outcome [7]
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Number of Disease Flares per Participant
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Assessment method [7]
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The number of disease flares per participant during Period 1 will be assessed.
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Timepoint [7]
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Up to Week 52
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Secondary outcome [8]
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Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
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Assessment method [8]
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The FACIT-Fatigue is a 13-item electronic-patient reported outcome (ePRO) measure of fatigue, which has been validated in the general population and in other chronic diseases. The FACIT-Fatigue content and measurement validity and related reliability has been extensively tested in the psoriatic arthritis (PsA) population, with evidence of reliability, construct validity, and responsiveness.
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Timepoint [8]
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From Week 0 to Week 52
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Secondary outcome [9]
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Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale
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Assessment method [9]
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The Treatment Satisfaction Questionnaire for Medications (TSQM) is a generic ePRO measure of treatment satisfaction, developed to compare treatment satisfaction between medication types and conditions. TSQM comprises of 14 items to assess 4 domains (effectiveness, side effects, convenience, and global satisfaction). The TSQM items are rated on a Likert scale (1 = extremely dissatisfied to 7 = extremely satisfied). Scores for each of the 4 domains range from 0 to 100, with higher scores corresponding to higher satisfaction.
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Timepoint [9]
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At Week 52
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Secondary outcome [10]
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Rate of CS-related Adverse Events
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Assessment method [10]
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The rate of CS-related adverse events will be assessed.
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Timepoint [10]
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At Week 52
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Eligibility
Key inclusion criteria
- Diagnosis of giant cell arteritis (GCA) according to the following criteria:
- History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity
C-reactive protein (hsCRP)/CRP >=1.0 mg/dL
- Presence of at least one of the following: Unequivocal cranial symptoms of GCA or
Unequivocal symptoms of polymyalgia rheumatica (PMR)
- Presence of at least one of the following: temporal artery biopsy revealing
features of GCA or evidence of large vessel vasculitis by angiography or
cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI),
computed tomography (CT) or positron emission tomography (PET).
- Active GCA, either new onset or relapsing, within 8 weeks of Baseline.
- Participants must have received treatment with >=40 mg prednisone (or equivalent) at
any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once
daily (QD) at Baseline.
- Participants must have GCA that, in the opinion of the investigator, is clinically
stable to allow the participant to safely initiate the protocol-defined corticosteroid
(CS) taper regimen.
- Females must either be postmenopausal or permanently surgically sterile or, practicing
at least 1 specified method of birth control through the study.
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Minimum age
50
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.
- Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or
prior treatment with an IL-6 inhibitor and experienced a disease flare during
treatment.
- Use of any of the following systemic immunosuppressant treatments within the specified
timeframe prior to study start:
- Anakinra within 1 week of study start.
- Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate
within 4 weeks of study start.
- Oral corticosteroid (CS) for conditions other than GCA within 4 week of study
start, or intravenous CS within 4 weeks of study start.
- Greater than or equal to 8 weeks for leflunomide if no elimination procedure was
followed, or adhere to an elimination procedure.
- Cell-depleting agents or alkylating agents including cyclophosphamide within 6
months of study start.
- Current or past history of infection including herpes zoster or herpes simplex, human
immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring
infection, active hepatitis B or C.
- Female who is pregnant, breastfeeding, or considering pregnancy during the study.
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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
Active, not recruiting
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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
24/01/2019
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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
3/03/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
429
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Emeritus Research Sydney /ID# 201937 - Botany
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Recruitment hospital [2]
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Prince of Wales Hospital /ID# 210995 - Randwick
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Recruitment hospital [3]
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Griffith University /ID# 223829 - Southport
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Recruitment hospital [4]
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The Queen Elizabeth Hospital /ID# 201939 - Woodville South
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Recruitment hospital [5]
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Emeritus Research /ID# 201938 - Camberwell
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Recruitment hospital [6]
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Fiona Stanley Hospital /ID# 201941 - Murdoch
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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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2031 - Randwick
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Recruitment postcode(s) [3]
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4222 - Southport
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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 postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Cantabria
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Country [102]
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Spain
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State/province [102]
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Pontevedra
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Country [103]
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0
Spain
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State/province [103]
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Santa Cruz De Tenerife
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Country [104]
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0
Spain
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State/province [104]
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0
Vizcaya
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Country [105]
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Spain
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State/province [105]
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0
A Coruna
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Country [106]
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0
Spain
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State/province [106]
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Barcelona
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Country [107]
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0
Spain
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State/province [107]
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Granada
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Country [108]
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Spain
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State/province [108]
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Madrid
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Country [109]
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Sweden
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State/province [109]
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Skane Lan
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Country [110]
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Sweden
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State/province [110]
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Stockholms Lan
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Country [111]
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Sweden
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State/province [111]
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Vastra Gotalands Lan
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Country [112]
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Sweden
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State/province [112]
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Stockholm
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Country [113]
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Sweden
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State/province [113]
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Uppsala
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Country [114]
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Sweden
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State/province [114]
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Vasteras
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Country [115]
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Switzerland
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State/province [115]
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Basel-Stadt
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Country [116]
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Switzerland
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State/province [116]
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Sankt Gallen
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Country [117]
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Switzerland
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State/province [117]
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Bern
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Country [118]
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Switzerland
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State/province [118]
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Fribourg
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Country [119]
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United Kingdom
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State/province [119]
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Bath And North East Somerset
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Country [120]
0
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United Kingdom
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State/province [120]
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Devon
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Country [121]
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United Kingdom
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State/province [121]
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Dorset
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Country [122]
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United Kingdom
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State/province [122]
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London, City Of
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Country [123]
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United Kingdom
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State/province [123]
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Coventry
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Country [124]
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United Kingdom
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State/province [124]
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Liverpool
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Country [125]
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United Kingdom
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State/province [125]
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Portsmouth
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Country [126]
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0
United Kingdom
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State/province [126]
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0
Southend
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Country [127]
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United Kingdom
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State/province [127]
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Torquay
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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
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Summary
Brief summary
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of
upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to
placebo in combination with a 52-week CS taper regimen, as measured by the proportion of
participants in sustained remission at Week 52, and to assess the safety and tolerability of
upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to
evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining
remission in participants who achieved sustained remission in Period 1.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03725202
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Phone
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03725202
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