A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis
SELECT-AXIS 1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis
2 other identifiers
interventional
187
21 countries
101
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2017
Typical duration for phase_2
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedStudy Start
First participant enrolled
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2019
CompletedResults Posted
Study results publicly available
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2022
CompletedMarch 7, 2023
February 1, 2023
1.2 years
June 5, 2017
May 6, 2021
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14
ASAS 40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Baseline and Week 14
Secondary Outcomes (12)
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
Baseline and Week 14
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14
Baseline and Week 14
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
Baseline and Week 14
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
Baseline and Week 14
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission
Week 14
- +7 more secondary outcomes
Study Arms (2)
Upadacitinib 15 mg
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (101)
Arizona Arthritis & Rheumatolo /ID# 164446
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 165705
Phoenix, Arizona, 85032-9306, United States
David S. Hallegua MD /ID# 165090
Beverly Hills, California, 90211, United States
Covina Arthritis Clinic /ID# 165061
Covina, California, 91722, United States
St. Joseph Health System /ID# 166166
Fullerton, California, 92835, United States
Global Research Foundation /ID# 165130
Los Angeles, California, 90041, United States
Rheumatology Center of San Diego /ID# 166167
San Diego, California, 92128-2549, United States
Colorado Arthritis Associates /ID# 164444
Lakewood, Colorado, 80228, United States
Bay Area Arthritis and Osteo /ID# 165023
Brandon, Florida, 33511, United States
LeJenue Research Associates /ID# 165202
Miami, Florida, 33126, United States
HMD Research LLC /ID# 205172
Orlando, Florida, 32819, United States
St. Lukes Clinic /ID# 165827
Meridian, Idaho, 83642, United States
Clinical Investigation Specialists - Skokie /ID# 164385
Skokie, Illinois, 60076, United States
Henry Ford Health System /ID# 165515
Detroit, Michigan, 48202, United States
Aa Mrc Llc /Id# 165100
Grand Blanc, Michigan, 48439, United States
St. Lawrence Health System /ID# 165025
Potsdam, New York, 13676, United States
DJL Clinical Research, PLLC /ID# 165044
Charlotte, North Carolina, 28210-8508, United States
Altoona Ctr Clinical Res /ID# 164470
Duncansville, Pennsylvania, 16635, United States
Clinical Research Ctr Reading /ID# 164876
Wyomissing, Pennsylvania, 19610, United States
Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 168107
Hendersonville, Tennessee, 37075-6213, United States
Diagnostic Group Integrated He /ID# 165195
Beaumont, Texas, 77701, United States
Arth and Osteo Clin Brazo Valley /ID# 165194
College Station, Texas, 77845, United States
Princess Alexandra Hospital /ID# 169239
Woolloongabba, Queensland, 4102, Australia
Emeritus Research /ID# 169240
Camberwell, Victoria, 3124, Australia
UZ Gent /ID# 166017
Ghent, Oost-Vlaanderen, 9000, Belgium
ReumaClinic Genk /ID# 166018
Genk, 3600, Belgium
UZ Leuven /ID# 166019
Leuven, 3000, Belgium
Rheumatology Research Assoc /ID# 165240
Edmonton, Alberta, T5M 0H4, Canada
University of Alberta - Division of Rheumatology /ID# 165239
Edmonton, Alberta, T6G 2B7, Canada
Credit Valley Rheumatology /ID# 200087
Mississauga, Ontario, L5M 2V8, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 165238
Sainte-Foy, Quebec, G1V 3M7, Canada
Clinical Hospital Dubrava /ID# 167049
Zagreb, 10000, Croatia
Medical Center Kuna-Peric /ID# 164851
Zagreb, 10000, Croatia
Revmatologicky ustav Praha /ID# 167004
Prague, Praha 2, 128 00, Czechia
Thomayerova nemocnice /ID# 167003
Prague, Praha 4, 140 00, Czechia
REVMACLINIC s.r.o. /ID# 167171
Brno, 611 41, Czechia
ARTHROHELP, s.r.o. /ID# 167001
Pardubice, 530 02, Czechia
Vejle Sygehus /ID# 165190
Vejle, Region Syddanmark, 7100, Denmark
Helsinki Univ Central Hospital /ID# 165794
Helsinki, 00290, Finland
Kiljava Medical Research /ID# 165793
Hyvinkää, 05800, Finland
CHU Bordeaux-Hopital Pellegrin /ID# 166309
Bordeaux, 33076, France
CHRU Tours - Hopital Trousseau /ID# 165109
Chambray-lès-Tours, 37170, France
CHRU de Montpellier - Hôpital Lapeyronie /ID# 166308
Montpellier, 34090, France
Rheumazentrum Ruhrgebiet /ID# 165148
Herne, North Rhine-Westphalia, 44649, Germany
Kerckhoff Klinik GmbH /ID# 165158
Bad Nauheim, 61231, Germany
Charite - Campus Benjamin Franklin Medizinische Klinik - Rheumatologie /ID# 165153
Berlin, 12203, Germany
Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 165146
Hamburg, 20095, Germany
Revita Reumatologiai Rendelo /ID# 164724
Budapest, 1027, Hungary
University of Debrecen /ID# 165674
Debrecen, 4032, Hungary
Vita Verum Medical Bt. /ID# 165066
Székesfehérvár, 8000, Hungary
Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 164741
Veszprém, 8200, Hungary
Ospedale Sant Orsola Malpighi /ID# 165692
Bologna, Emilia-Romagna, 40138, Italy
Policlinico Paolo Giaccone /Id# 165663
Palermo, Sicily, 90127, Italy
ASST G. Pini /ID# 165715
Milan, 20122, Italy
A.O. Universitaria Senese /ID# 165716
Siena, 53100, Italy
Hospital of the University of Occupational and Environmental Health /ID# 164380
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Gunma University Hospital /ID# 165683
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Asahikawa Medical Center /ID# 164566
Asahikawa-shi, Hokkaido, 070-8644, Japan
Kagawa University Hospital /ID# 167517
Kita-gun, Kagawa-ken, 761-0793, Japan
Kochi Medical School Hospital /ID# 164460
Nankoku-shi, Kochi, 783-8505, Japan
Shinshu University Hospital /ID# 165304
Matsumoto-shi, Nagano, 390-8621, Japan
Japanese Red Cross Okayama Hospital /ID# 164376
Okayama, Okayama-ken, 7008607, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 164365
Kawachinagano-shi, Osaka, 586-8521, Japan
Osaka City University Hospital /ID# 165253
Osaka, Osaka, 545-8586, Japan
Osaka University Hospital /ID# 166033
Suita-shi, Osaka, 565-0871, Japan
Saitama Medical University Hospital /ID# 164577
Iruma-gun, Saitama, 350-0451, Japan
Juntendo University Koshigaya Hospital /ID# 165809
Koshigaya-shi, Saitama, 343-0032, Japan
Tokushima University Hospital /ID# 165108
Tokushima, Tokushima, 770-8503, Japan
Juntendo University Hospital /ID# 164738
Bunkyo-ku, Tokyo, 113-8431, Japan
St.Luke's International Hospital /ID# 165219
Chuo-ku, Tokyo, 104-8560, Japan
Daido Hospital /ID# 163886
Nagoya, 457-8511, Japan
Okayama Saiseikai Outpatient Center Hospital /ID# 165595
Okayama, 700-0013, Japan
Universitair Medisch Centrum Groningen /ID# 165681
Groningen, 9713 GZ, Netherlands
Medisch Centrum Leeuwarden /ID# 166937
Leeuwarden, 8934 AD, Netherlands
Waikato Hospital /ID# 169242
Hamilton, Waikato Region, 3204, New Zealand
Middlemore Hospital /ID# 169241
Auckland, 2025, New Zealand
Osteo-Medic S.C. /ID# 165646
Bialystok, Podlaskie Voivodeship, 15-351, Poland
ETYKA-Osrodek Badan Klinicznyc /ID# 165634
Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland
NZOZ Nasz Lekarz /ID# 166023
Torun, 87-100, Poland
Instituto Portugues De Reumatologia /ID# 168314
Lisbon, Lisbon District, 1050-034, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 168312
Lisbon, Lisbon District, 1349-019, Portugal
Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 168313
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Hospital CUF Descobertas /ID# 168311
Lisbon, 1998-018, Portugal
Unidade Local De Saude Do Alto Minho /ID# 168310
Viana do Castelo, 4901-858, Portugal
Chungnam National University Hospital /ID# 164561
Junggu, Daejeon Gwang Yeogsi, 35015, South Korea
Gachon University Gil Medical Center /ID# 165114
Incheon, Incheon Gwang Yeogsi, 21565, South Korea
Chonnam National University Hospital /ID# 164541
Gwangju, Jeonranamdo, 61469, South Korea
Hanyang University Seoul Hospi /ID# 165811
Seongdong-gu, Seoul Teugbyeolsi, 04763, South Korea
Cath Univ Seoul St Mary's Hosp /ID# 164549
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Kyunghee University Hospital at Gangdong /ID# 164569
Seoul, 02447, South Korea
Asan Medical Center /ID# 164557
Seoul, 05505, South Korea
Hospital Unversitario Marques de Valdecilla /ID# 165028
Santander, Cantabria, 39008, Spain
Hospital Parc de Salut del Mar /ID# 165027
Barcelona, 08003, Spain
Corporac Sanitaria Parc Tauli /ID# 165029
Barcelona, 08006, Spain
Skanes Universitetssjukhus /ID# 165712
Malmo, Skåne County, 214 28, Sweden
Reumatologkliniken /ID# 165713
Västerås, 721 89, Sweden
Warrington and Halton Hospitals NHS Foundation Trust /ID# 166202
Warrington, Cheshire West And Chester, WA5 1QG, United Kingdom
Whipps Cross Univ Hospital /ID# 165150
London, London, City of, E11 1NR, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 165149
Norwich, Norfolk, NR4 7UY, United Kingdom
Royal National Hosp for Rheuma /ID# 165147
Bath, BA1 1RL, United Kingdom
Glasgow Royal Infirmary /ID# 165152
Glasgow, G4 0SF, United Kingdom
Related Publications (8)
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.
PMID: 31732180BACKGROUNDBurmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
PMID: 40875187DERIVEDNavarro-Compan V, Van den Bosch F, Sampaio-Barros PD, Ostor AJK, Parikh B, Kato K, Gao T, Stigler J, Ramiro S. Efficacy of upadacitinib in subgroups of patients with axial spondyloarthritis with early versus established disease. RMD Open. 2025 Mar 4;11(1):e005110. doi: 10.1136/rmdopen-2024-005110.
PMID: 40037923DERIVEDBurmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.
PMID: 38683479DERIVEDRubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
PMID: 37982966DERIVEDCharles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.
PMID: 37945286DERIVEDBurmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.
PMID: 36754548DERIVEDDeodhar 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.
PMID: 34196498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 7, 2017
Study Start
October 24, 2017
Primary Completion
January 21, 2019
Study Completion
February 17, 2022
Last Updated
March 7, 2023
Results First Posted
June 1, 2021
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- 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/
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.