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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

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.
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
Timepoint [1] 0 0
At Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Sustained Complete Remission
Timepoint [1] 0 0
Week 12 through Week 52
Secondary outcome [2] 0 0
Cumulative Corticosteroid (CS) exposure
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [3] 0 0
Time to First Disease Flare
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Percentage of Participants Who Experience at Least 1 Disease Flare
Timepoint [4] 0 0
Up to Week 52
Secondary outcome [5] 0 0
Percentage of Participants in Complete Remission
Timepoint [5] 0 0
Up to Week 52
Secondary outcome [6] 0 0
Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS)
Timepoint [6] 0 0
At Week 52
Secondary outcome [7] 0 0
Number of Disease Flares per Participant
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [8] 0 0
From Week 0 to Week 52
Secondary outcome [9] 0 0
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale
Timepoint [9] 0 0
At Week 52
Secondary outcome [10] 0 0
Rate of CS-related Adverse Events
Timepoint [10] 0 0
At 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/03/2025
Actual
Sample size
Target
Accrual to date
Final
429
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
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Alabama
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Arizona
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Louisiana
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Maine
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Devon
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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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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, analyses plans, 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)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03725202