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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03725202
Registration number
NCT03725202
Ethics application status
Date submitted
27/10/2018
Date registered
30/10/2018
Date last updated
27/03/2025
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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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
Placebo comparator: Placebo + 52-week CS taper - Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
Experimental: 7.5 mg Upadacitinib + 26-week CS taper - Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Experimental: 15 mg Upadacitinib + 26-week CS taper - Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
Placebo comparator: Placebo + 52-week CS taper -> Placebo - Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR at remission at the Week 52 visit only who were assigned to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
Experimental: 7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg Upadacitinib - Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
Experimental: 7.5 mg Upadacitinib + 26-week CS taper -> Placebo - Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
Experimental: 15 mg Upadacitinib + 26-week CS taper -> 15 mg Upadacitinib - Participants received 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
Experimental: 15 mg Upadacitinib + 26-week CS taper -> Placebo - Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
Treatment: Drugs: Upadacitinib
Administered orally once a day
Treatment: Drugs: Corticosteroid (CS)
At Baseline, all participants switched to corticosteroids (CS) provided by the sponsor with the oral prednisone or prednisolone dose at 20, 30, 40, 50, or 60 mg QD. The initial dose of prednisone or prednisolone was at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 20 mg QD at Baseline. At Baseline, if a participant was on a dose other than 20, 30, 40, 50, or 60 mg QD, the dose was rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. Prednisone or prednisolone was tapered according to a predefined schedule over a 26- or 52-week period. Open-label prednisone or prednisolone was provided until the dose was tapered to 20 mg/day. Subsequently, blinded prednisone or prednisolone was provided for the remaining blinded taper regimen through Week 52.
Other interventions: Placebo
Administered orally once a day
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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 at Week 52
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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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From Week 12 to Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52
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Assessment method [1]
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Sustained complete remission is defined as having absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52; 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 Through Week 52
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Assessment method [2]
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The cumulative exposure to corticosteroid(s) through Week 52 of the study was documented.
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Timepoint [2]
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Baseline up to Week 52
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Secondary outcome [3]
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Time to First Disease Flare Through Week 52
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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 Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement \> 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
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Timepoint [3]
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Baseline 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 Through Week 52
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Assessment method [4]
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The percentage of participants who experience at least 1 disease flare was calculated. Disease flare is defined as an event determined by the investigator to represent recurrence of Giant Cell Arteritis (GCA) signs or symptoms or an erythrocyte sedimentation rate (ESR) measurement \> 30 mm/hr (attributable to GCA) AND requiring an increase in corticosteroid (CS) dose.
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Timepoint [4]
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Baseline up to Week 52
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Secondary outcome [5]
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Percentage of Participants in Complete Remission at Week 52
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Assessment method [5]
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Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to \< 30 mm/hr-- if ESR =30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to \< 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
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Timepoint [5]
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At Week 52
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Secondary outcome [6]
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Percentage of Participants in Complete Remission at Week 24
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Assessment method [6]
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Complete remission is defined as having achieved absence of Giant Cell Arteritis (GCA) signs and symptoms; normalization of erythrocyte sedimentation rate (ESR) to \< 30 mm/hr-- if ESR =30 mm/hr and elevation is not attributable to GCA, this criterion can still be met); normalization of high sensitivity C-reactive protein (hs-CRP) to \< 1 mg/dL; and adherence to the protocol-defined corticosteroid (CS) taper regimen.
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Timepoint [6]
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At Week 24
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Secondary outcome [7]
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Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52
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Assessment method [7]
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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 (PCS) is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from the Baseline score indicates improvement.
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Timepoint [7]
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Baseline, Week 52
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Secondary outcome [8]
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Number of Disease Flares Per Participant Through Week 52
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Assessment method [8]
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The number of disease flares per participant during Period 1 was documented, and was adjusted by the duration of study participation.
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Timepoint [8]
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Baseline up to Week 52
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Secondary outcome [9]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52
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Assessment method [9]
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The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue, functional fatigue, emotional fatigue, and social consequences of fatigue. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing items worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
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Timepoint [9]
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Baseline, Week 52
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Secondary outcome [10]
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Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52
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Assessment method [10]
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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. A positive change from Baseline indicates improvement.
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Timepoint [10]
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At Week 52
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Secondary outcome [11]
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Rate of Corticosteroid-related Adverse Events Though Week 52
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Assessment method [11]
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The rate of corticosteroid-related adverse events was calculated, and was adjusted by duration of study drug exposure.
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Timepoint [11]
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Baseline up to 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
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
6/02/2019
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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
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Actual
24/02/2025
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Sample size
Target
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Accrual to date
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Final
438
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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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The Queen Elizabeth Hospital /ID# 201939 - Woodville South
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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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2031 - Randwick
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4222 - Southport
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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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Netherlands
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Gelderland
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Limburg
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Netherlands
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Overijssel
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Groningen
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New Zealand
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Auckland
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Canterbury
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Nelson
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Norway
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Hordaland
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Norway
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Oslo
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Portugal
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Porto
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Portugal
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Viana Do Castelo
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Portugal
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Guarda
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Portugal
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Cluj
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Romania
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Timis
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Bucuresti
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Russian Federation
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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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Sweden
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Stockholm
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Sweden
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Switzerland
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Bern
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Switzerland
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Fribourg
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United Kingdom
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Bath And North East Somerset
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United Kingdom
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Devon
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United Kingdom
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Southend
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United Kingdom
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Torquay
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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
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. Safety and efficacy data through 06 February 2024 are included in the interim analysis, which was conducted after all participants completed the Week 52 visit or discontinued from the study.
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Trial website
https://clinicaltrials.gov/study/NCT03725202
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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
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/02/NCT03725202/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/02/NCT03725202/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03725202
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