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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03178487




Registration number
NCT03178487
Ethics application status
Date submitted
5/06/2017
Date registered
7/06/2017

Titles & IDs
Public title
A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis
Secondary ID [1] 0 0
2017-000431-14
Secondary ID [2] 0 0
M16-098
Universal Trial Number (UTN)
Trial acronym
SELECT-AXIS 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis (AS) 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo

Experimental: Upadacitinib 15 mg - Participants will receive 15 mg upadacitinib orally once a day for 14 weeks in Period 1 and continue to receive 15 mg upadacitinib orally once a day for an additional 90 weeks in Period 2.

Placebo comparator: Placebo - Participants will receive matching placebo orally once a day for 14 weeks in Period 1. In Period 2 participants will receive 15 mg upadacitinib orally once a day for 90 weeks.


Treatment: Drugs: Upadacitinib
Tablet

Treatment: Drugs: Placebo
Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14
Timepoint [1] 0 0
Baseline and Week 14
Secondary outcome [1] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
Timepoint [1] 0 0
Baseline and Week 14
Secondary outcome [2] 0 0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14
Timepoint [2] 0 0
Baseline and Week 14
Secondary outcome [3] 0 0
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
Timepoint [3] 0 0
Baseline and Week 14
Secondary outcome [4] 0 0
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
Timepoint [4] 0 0
Baseline and Week 14
Secondary outcome [5] 0 0
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
Timepoint [6] 0 0
Baseline and Week 14
Secondary outcome [7] 0 0
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
Timepoint [7] 0 0
Baseline and Week 14
Secondary outcome [8] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
Timepoint [8] 0 0
Baseline and Week 14
Secondary outcome [9] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 14
Timepoint [9] 0 0
Baseline and Week 14
Secondary outcome [10] 0 0
Change From Baseline in ASAS Health Index (HI) at Week 14
Timepoint [10] 0 0
Baseline and Week 14
Secondary outcome [11] 0 0
Percentage of Participants Achieving an ASAS 20 Response at Week 14
Timepoint [11] 0 0
Baseline and Week 14
Secondary outcome [12] 0 0
Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14
Timepoint [12] 0 0
Baseline and Week 14

Eligibility
Key inclusion criteria
* Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
* Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
* Participant has had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
* If entering the study on concomitant methotrexate (MTX), leflunomide, sulfasalazine (SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX (<= 25 mg/week) and/or SSZ (<= 3 g/day) and/or hydroxychloroquine (<= 400 mg/day) or leflunomide (<= 20 mg/day) for at least 28 days prior to the Baseline visit. A combination of up to two background conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) is allowed except the combination of MTX and leflunomide.
* If entering the study on concomitant oral corticosteroids, participant must be on a stable dose of prednisone (<= 10 mg/day), or oral corticosteroid equivalents, for at least 14 days prior to the Baseline visit.
* If entering the study on concomitant NSAIDs, tramadol, combination of acetaminophen and codeine or hydrocodone, and/or non-opioid analgesics, participant must be on stable dose(s) for at least 14 days prior to the Baseline visit.
Minimum age
18 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 (including but not limited to tofacitinib, baricitinib, and filgotinib).
* Prior exposure to any biologic therapy with a potential therapeutic impact on spondyloarthritis (SpA).
* Intra-articular joint injections, spinal/paraspinal injection(s), or parenteral administration of corticosteroids within 28 days prior to the Baseline visit. Inhaled or topical corticosteroids are allowed.
* Participant on any other DMARDs (other than those allowed), thalidomide or apremilast within 28 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.
* Participant on opioid analgesics (except for combination acetaminophen/codeine or acetaminophen/hydrocodone which are allowed) or use of inhaled marijuana within 14 days prior to the Baseline visit.
* Participant has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age.
* Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal (ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula < 40 milliliter (mL)/minute/1.73m^2; hemoglobin < 10 gram/deciliter, total white blood cell count < 2,500/microliter (µL); absolute neutrophil count < 1,500/µL; absolute lymphocyte count < 800/µL; and platelet count < 100,000/µL.

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 2
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
24/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2022
Sample size
Target
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital /ID# 169239 - Woolloongabba
Recruitment hospital [2] 0 0
Emeritus Research /ID# 169240 - Camberwell
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Belgium
State/province [13] 0 0
Oost-Vlaanderen
Country [14] 0 0
Belgium
State/province [14] 0 0
Genk
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Croatia
State/province [19] 0 0
Zagreb
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha 2
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 4
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Czechia
State/province [23] 0 0
Pardubice
Country [24] 0 0
Denmark
State/province [24] 0 0
Syddanmark
Country [25] 0 0
Finland
State/province [25] 0 0
Helsinki
Country [26] 0 0
Finland
State/province [26] 0 0
Hyvinkaa
Country [27] 0 0
France
State/province [27] 0 0
Bordeaux
Country [28] 0 0
France
State/province [28] 0 0
Chambray Les Tours
Country [29] 0 0
France
State/province [29] 0 0
Montpellier
Country [30] 0 0
Germany
State/province [30] 0 0
Nordrhein-Westfalen
Country [31] 0 0
Germany
State/province [31] 0 0
Bad Nauheim
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Debrecen
Country [36] 0 0
Hungary
State/province [36] 0 0
Szekesfehervar
Country [37] 0 0
Hungary
State/province [37] 0 0
Veszprem
Country [38] 0 0
Italy
State/province [38] 0 0
Emilia-Romagna
Country [39] 0 0
Italy
State/province [39] 0 0
Sicilia
Country [40] 0 0
Italy
State/province [40] 0 0
Milan
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Italy
State/province [41] 0 0
Siena
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Japan
State/province [42] 0 0
Fukuoka
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Kagawa
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Japan
State/province [46] 0 0
Kochi
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Japan
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Nagano
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Japan
State/province [48] 0 0
Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokushima
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Japan
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Tokyo
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Japan
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Nagoya
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Korea, Republic of
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Daejeon Gwang Yeogsi
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Korea, Republic of
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Incheon Gwang Yeogsi
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Korea, Republic of
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Jeonranamdo
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Korea, Republic of
State/province [57] 0 0
Seoul Teugbyeolsi
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seoul
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Netherlands
State/province [59] 0 0
Groningen
Country [60] 0 0
Netherlands
State/province [60] 0 0
Leeuwarden
Country [61] 0 0
New Zealand
State/province [61] 0 0
Waikato
Country [62] 0 0
New Zealand
State/province [62] 0 0
Auckland
Country [63] 0 0
Poland
State/province [63] 0 0
Podlaskie
Country [64] 0 0
Poland
State/province [64] 0 0
Warminsko-mazurskie
Country [65] 0 0
Poland
State/province [65] 0 0
Torun
Country [66] 0 0
Portugal
State/province [66] 0 0
Lisboa
Country [67] 0 0
Portugal
State/province [67] 0 0
Porto
Country [68] 0 0
Portugal
State/province [68] 0 0
Lisbon
Country [69] 0 0
Portugal
State/province [69] 0 0
Viana Do Castelo
Country [70] 0 0
Spain
State/province [70] 0 0
Cantabria
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Sweden
State/province [72] 0 0
Skane Lan
Country [73] 0 0
Sweden
State/province [73] 0 0
Vaesteras
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Cheshire West And Chester
Country [75] 0 0
United Kingdom
State/province [75] 0 0
London, City Of
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Norfolk
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Bath
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Glasgow

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03178487