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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03725202




Registration number
NCT03725202
Ethics application status
Date submitted
27/10/2018
Date registered
30/10/2018
Date last updated
12/06/2020

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
2017-003978-13
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 - Sustained remission is defined as having achieved absence of GCA signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined CS taper regimen.
Timepoint [1] 0 0
At Week 52
Secondary outcome [1] 0 0
Percentage of participants achieving sustained complete remission - Sustained complete remission is defined as having absence of GCA signs and symptoms; normalization of ESR; Normalization of high sensitivity C-reactive protein (hs-CRP) and adherence to the protocol-defined CS taper regimen.
Timepoint [1] 0 0
Week 12 through Week 52
Secondary outcome [2] 0 0
Cumulative CS exposure - The cumulative exposure to corticosteroid(s) is assessed.
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [3] 0 0
Time to disease flare - 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.
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Percentage of participants who experience at least 1 disease flare - The percentage of participants who experience at least 1 disease flare is assessed
Timepoint [4] 0 0
Up to Week 52
Secondary outcome [5] 0 0
Percentage of participants in complete remission - 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.
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Percentage of participants in complete remission - 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.
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS) - 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.
Timepoint [7] 0 0
At Week 52
Secondary outcome [8] 0 0
Number of disease flares per participant during Period 1 - The number of disease flares per participant during Period 1 will be assessed.
Timepoint [8] 0 0
Up to Week 52
Secondary outcome [9] 0 0
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) - The FACIT-F 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-F 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.
Timepoint [9] 0 0
From Week 0 to Week 52
Secondary outcome [10] 0 0
Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale - 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.
Timepoint [10] 0 0
At Week 52
Secondary outcome [11] 0 0
Rate of CS-related Adverse Events - The rate of CS-related adverse events will be assessed.
Timepoint [11] 0 0
At Week 52

Eligibility
Key inclusion criteria
1. 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).

2. Active GCA, either new onset or relapsing, within 6 weeks of Baseline.

3. 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.

4. 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.

5. 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior exposure to any Janus Kinase (JAK) inhibitor.

2. 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.

3. 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.

4. Current or past history of infection including herpes zoster or herpes simplex, HIV,
active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.

5. 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Optimus Clinical Research Pty. /ID# 201937 - Kogarah
Recruitment hospital [2] 0 0
The Prince of Wales Hospital /ID# 210995 - Randwick
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital /ID# 201939 - Woodville
Recruitment hospital [4] 0 0
Emeritus Research /ID# 201938 - Camberwell
Recruitment hospital [5] 0 0
Fiona Stanley Hospital /ID# 201941 - Murdoch
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

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 remission in Period 1.
Trial website
https://clinicaltrials.gov/show/NCT03725202
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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03725202