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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

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
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
Secondary ID [1] 0 0
2023-505476-29-00
Secondary ID [2] 0 0
M16-852
Universal Trial Number (UTN)
Trial acronym
SELECT-GCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis (GCA) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Sustained Remission at Week 52
Timepoint [1] 0 0
From Week 12 to Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52
Timepoint [1] 0 0
Week 12 through Week 52
Secondary outcome [2] 0 0
Cumulative Corticosteroid (CS) Exposure Through Week 52
Timepoint [2] 0 0
Baseline up to Week 52
Secondary outcome [3] 0 0
Time to First Disease Flare Through Week 52
Timepoint [3] 0 0
Baseline up to Week 52
Secondary outcome [4] 0 0
Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52
Timepoint [4] 0 0
Baseline up to Week 52
Secondary outcome [5] 0 0
Percentage of Participants in Complete Remission at Week 52
Timepoint [5] 0 0
At Week 52
Secondary outcome [6] 0 0
Percentage of Participants in Complete Remission at Week 24
Timepoint [6] 0 0
At Week 24
Secondary outcome [7] 0 0
Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Number of Disease Flares Per Participant Through Week 52
Timepoint [8] 0 0
Baseline up to Week 52
Secondary outcome [9] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52
Timepoint [10] 0 0
At Week 52
Secondary outcome [11] 0 0
Rate of Corticosteroid-related Adverse Events Though Week 52
Timepoint [11] 0 0
Baseline up to Week 52

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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2025
Sample size
Target
Accrual to date
Final
438
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 201937 - Botany
Recruitment hospital [2] 0 0
Prince of Wales Hospital /ID# 210995 - Randwick
Recruitment hospital [3] 0 0
Griffith University /ID# 223829 - Southport
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital /ID# 201939 - Woodville South
Recruitment hospital [5] 0 0
Emeritus Research /ID# 201938 - Camberwell
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 201941 - Murdoch
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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Colorado
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Connecticut
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03725202