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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
Date last updated
7/03/2023

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
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Arizona
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California
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Colorado
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Florida
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Idaho
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Michigan
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New York
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North Carolina
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Pennsylvania
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Tennessee
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United States of America
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Texas
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Belgium
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Oost-Vlaanderen
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Belgium
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Genk
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Croatia
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Zagreb
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Czechia
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Praha 2
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Czechia
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Praha 4
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Czechia
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Brno
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Pardubice
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Helsinki
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Finland
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Hyvinkaa
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France
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Bordeaux
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France
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Chambray Les Tours
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France
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Montpellier
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Germany
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Nordrhein-Westfalen
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Germany
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Bad Nauheim
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Germany
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Berlin
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Germany
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Hamburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szekesfehervar
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Hungary
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Veszprem
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Italy
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Emilia-Romagna
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Italy
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Sicilia
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Italy
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Milan
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Italy
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Siena
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Japan
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Fukuoka
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Gunma
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Hokkaido
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Kagawa
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Japan
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Kochi
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Nagano
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Okayama
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Osaka
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Japan
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Saitama
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Tokushima
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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
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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Netherlands
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Groningen
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Netherlands
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Leeuwarden
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New Zealand
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Waikato
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New Zealand
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Auckland
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Poland
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Podlaskie
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Poland
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Warminsko-mazurskie
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Poland
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Torun
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Lisbon
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Portugal
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Viana Do Castelo
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Spain
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Cantabria
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Spain
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Barcelona
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Sweden
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Skane Lan
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Sweden
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Vaesteras
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United Kingdom
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Cheshire West And Chester
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United Kingdom
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London, City Of
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United Kingdom
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Norfolk
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United Kingdom
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Bath
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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
The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
Trial website
https://clinicaltrials.gov/study/NCT03178487
Trial related presentations / publications
van der Heijde D, Song IH, Pangan AL, Deodhar A, van den Bosch F, Maksymowych WP, Kim TH, Kishimoto M, Everding A, Sui Y, Wang X, Chu AD, Sieper J. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.
Deodhar A, van der Heijde D, Sieper J, Van den Bosch F, Maksymowych WP, Kim TH, Kishimoto M, Ostor A, Combe B, Sui Y, Chu AD, Song IH. Safety and Efficacy of Upadacitinib in Patients With Active Ankylosing Spondylitis and an Inadequate Response to Nonsteroidal Antiinflammatory Drug Therapy: One-Year Results of a Double-Blind, Placebo-Controlled Study and Open-Label Extension. Arthritis Rheumatol. 2022 Jan;74(1):70-80. doi: 10.1002/art.41911. Epub 2021 Nov 12.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03178487