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A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis (SELECT-AXIS 1)

Primary Purpose

Ankylosing Spondylitis (AS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis (AS) focused on measuring Upadacitinib, ABT-494, Ankylosing Spondylitis (AS), Safety, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Arizona Arthritis & Rheumatolo /ID# 164446
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 165705
  • David S. Hallegua MD /ID# 165090
  • Covina Arthritis Clinic /ID# 165061
  • St. Joseph Health System /ID# 166166
  • Global Research Foundation /ID# 165130
  • Rheumatology Center of San Diego /ID# 166167
  • Colorado Arthritis Associates /ID# 164444
  • Bay Area Arthritis and Osteo /ID# 165023
  • LeJenue Research Associates /ID# 165202
  • HMD Research LLC /ID# 205172
  • St. Lukes Clinic /ID# 165827
  • Clinical Investigation Specialists - Skokie /ID# 164385
  • Henry Ford Health System /ID# 165515
  • Aa Mrc Llc /Id# 165100
  • St. Lawrence Health System /ID# 165025
  • DJL Clinical Research, PLLC /ID# 165044
  • Altoona Ctr Clinical Res /ID# 164470
  • Clinical Research Ctr Reading /ID# 164876
  • Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 168107
  • Diagnostic Group Integrated He /ID# 165195
  • Arth and Osteo Clin Brazo Valley /ID# 165194
  • Princess Alexandra Hospital /ID# 169239
  • Emeritus Research /ID# 169240
  • UZ Gent /ID# 166017
  • ReumaClinic Genk /ID# 166018
  • UZ Leuven /ID# 166019
  • Rheumatology Research Assoc /ID# 165240
  • University of Alberta - Division of Rheumatology /ID# 165239
  • Credit Valley Rheumatology /ID# 200087
  • Groupe de Recherche en Maladies Osseuses Inc /ID# 165238
  • Clinical Hospital Dubrava /ID# 167049
  • Medical Center Kuna-Peric /ID# 164851
  • Revmatologicky ustav Praha /ID# 167004
  • Thomayerova nemocnice /ID# 167003
  • REVMACLINIC s.r.o. /ID# 167171
  • ARTHROHELP, s.r.o. /ID# 167001
  • Vejle Sygehus /ID# 165190
  • Helsinki Univ Central Hospital /ID# 165794
  • Kiljava Medical Research /ID# 165793
  • CHU Bordeaux-Hopital Pellegrin /ID# 166309
  • CHRU Tours - Hopital Trousseau /ID# 165109
  • CHRU de Montpellier - Hôpital Lapeyronie /ID# 166308
  • Rheumazentrum Ruhrgebiet /ID# 165148
  • Kerckhoff Klinik GmbH /ID# 165158
  • Charite - Campus Benjamin Franklin Medizinische Klinik - Rheumatologie /ID# 165153
  • Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 165146
  • Revita Reumatologiai Rendelo /ID# 164724
  • University of Debrecen /ID# 165674
  • Vita Verum Medical Bt. /ID# 165066
  • Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 164741
  • Ospedale Sant Orsola Malpighi /ID# 165692
  • Policlinico Paolo Giaccone /Id# 165663
  • ASST G. Pini /ID# 165715
  • A.O. Universitaria Senese /ID# 165716
  • Hospital of the University of Occupational and Environmental Health /ID# 164380
  • Gunma University Hospital /ID# 165683
  • National Hospital Organization Asahikawa Medical Center /ID# 164566
  • Kagawa University Hospital /ID# 167517
  • Kochi Medical School Hospital /ID# 164460
  • Shinshu University Hospital /ID# 165304
  • Japanese Red Cross Okayama Hospital /ID# 164376
  • National Hospital Organization Osaka Minami Medical Center /ID# 164365
  • Osaka City University Hospital /ID# 165253
  • Osaka University Hospital /ID# 166033
  • Saitama Medical University Hospital /ID# 164577
  • Juntendo University Koshigaya Hospital /ID# 165809
  • Tokushima University Hospital /ID# 165108
  • Juntendo University Hospital /ID# 164738
  • St.Luke's International Hospital /ID# 165219
  • Daido Hospital /ID# 163886
  • Okayama Saiseikai Outpatient Center Hospital /ID# 165595
  • Chungnam National University Hospital /ID# 164561
  • Gachon University Gil Medical Center /ID# 165114
  • Chonnam National University Hospital /ID# 164541
  • Hanyang University Seoul Hospi /ID# 165811
  • Cath Univ Seoul St Mary's Hosp /ID# 164549
  • Kyunghee University Hospital at Gangdong /ID# 164569
  • Asan Medical Center /ID# 164557
  • Universitair Medisch Centrum Groningen /ID# 165681
  • Medisch Centrum Leeuwarden /ID# 166937
  • Waikato Hospital /ID# 169242
  • Middlemore Hospital /ID# 169241
  • Osteo-Medic S.C. /ID# 165646
  • ETYKA-Osrodek Badan Klinicznyc /ID# 165634
  • NZOZ Nasz Lekarz /ID# 166023
  • Instituto Portugues De Reumatologia /ID# 168314
  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 168312
  • Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 168313
  • Hospital CUF Descobertas /ID# 168311
  • Unidade Local De Saude Do Alto Minho /ID# 168310
  • Hospital Unversitario Marques de Valdecilla /ID# 165028
  • Hospital Parc de Salut del Mar /ID# 165027
  • Corporac Sanitaria Parc Tauli /ID# 165029
  • Skanes Universitetssjukhus /ID# 165712
  • Reumatologkliniken /ID# 165713
  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 166202
  • Whipps Cross Univ Hospital /ID# 165150
  • Norfolk and Norwich Univ Hosp /ID# 165149
  • Royal National Hosp for Rheuma /ID# 165147
  • Glasgow Royal Infirmary /ID# 165152

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Upadacitinib 15 mg

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14
In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions. Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice. The maximum (worst) overall score for all 6 DVUs is 108.
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0). Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission
ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains: 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).
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and intermalleolar distance (in cm). Each measurement is converted to a linear score between 0 and 10. The total BASMI score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 14
The Work Productivity and Activity Impairment Questionnaire: Axial Spondyloarthritis, Version 2.0 (WPAI-Axial Spondyloarthritis) measures the effect of overall health and specific symptoms on productivity at work and outside of work. It consists of 6 questions. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Overall Work Impairment indicates the percentage of overall work impairment due to health problems. A negative change from Baseline indicates improvement.
Change From Baseline in ASAS Health Index (HI) at Week 14
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Percentage of Participants Achieving an ASAS 20 Response at Week 14
ASAS 20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain: Patient's global assessment of disease activity, measured on a 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 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 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).
Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14
In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema. Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The total maximum score for all SI joints across 6 slices is 72.

Full Information

First Posted
June 5, 2017
Last Updated
February 6, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03178487
Brief Title
A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis
Acronym
SELECT-AXIS 1
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
This study includes two periods: a 14-week double-blind placebo-controlled period and a 90-week open-label long-term extension period. Eligible participants were randomly assigned in a 1:1 ratio to receive upadacitinib 15 mg or placebo for 14 weeks in Period 1. Participants who completed Period 1 received upadacitinib 15 mg for 90 weeks in the extension period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis (AS)
Keywords
Upadacitinib, ABT-494, Ankylosing Spondylitis (AS), Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upadacitinib 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494, RINVOQ™
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14
Description
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).
Time Frame
Baseline and Week 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Time Frame
Baseline and Week 14
Title
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14
Description
In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions. Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice. The maximum (worst) overall score for all 6 DVUs is 108.
Time Frame
Baseline and Week 14
Title
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
Description
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Time Frame
Baseline and Week 14
Title
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
Description
The ASQoL consists of 18 items related to quality of life, including the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. Each item is answered as yes (scored as 1) or no (scored as 0). Scores are summed to obtain the overall score which ranges from 0 to 18, where higher scores indicate a worse quality of life. A negative change from Baseline in ASQoL indicates improvement in quality of life.
Time Frame
Baseline and Week 14
Title
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission
Description
ASAS partial remission (PR) is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains: 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).
Time Frame
Week 14
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
Description
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Time Frame
Baseline and Week 14
Title
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
Description
The BASMI is a composite score based on 5 direct measurements of spinal mobility: cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and intermalleolar distance (in cm). Each measurement is converted to a linear score between 0 and 10. The total BASMI score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 14
Title
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
Description
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses.
Time Frame
Baseline and Week 14
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 14
Description
The Work Productivity and Activity Impairment Questionnaire: Axial Spondyloarthritis, Version 2.0 (WPAI-Axial Spondyloarthritis) measures the effect of overall health and specific symptoms on productivity at work and outside of work. It consists of 6 questions. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Overall Work Impairment indicates the percentage of overall work impairment due to health problems. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 14
Title
Change From Baseline in ASAS Health Index (HI) at Week 14
Description
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 14
Title
Percentage of Participants Achieving an ASAS 20 Response at Week 14
Description
ASAS 20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain: Patient's global assessment of disease activity, measured on a 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 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 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).
Time Frame
Baseline and Week 14
Title
Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14
Description
In the SPARCC MRI assessment of the sacroiliac (SI) joints 6 consecutive sacroiliac joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema. Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema, intensity of edema (a score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice), and a lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The total maximum score for all SI joints across 6 slices is 72.
Time Frame
Baseline and Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatolo /ID# 164446
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 165705
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
David S. Hallegua MD /ID# 165090
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Covina Arthritis Clinic /ID# 165061
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
St. Joseph Health System /ID# 166166
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Global Research Foundation /ID# 165130
City
Los Angeles
State/Province
California
ZIP/Postal Code
90041
Country
United States
Facility Name
Rheumatology Center of San Diego /ID# 166167
City
San Diego
State/Province
California
ZIP/Postal Code
92128-2549
Country
United States
Facility Name
Colorado Arthritis Associates /ID# 164444
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Bay Area Arthritis and Osteo /ID# 165023
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
LeJenue Research Associates /ID# 165202
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
HMD Research LLC /ID# 205172
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
St. Lukes Clinic /ID# 165827
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Clinical Investigation Specialists - Skokie /ID# 164385
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Henry Ford Health System /ID# 165515
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Aa Mrc Llc /Id# 165100
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
St. Lawrence Health System /ID# 165025
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Facility Name
DJL Clinical Research, PLLC /ID# 165044
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8508
Country
United States
Facility Name
Altoona Ctr Clinical Res /ID# 164470
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Ctr Reading /ID# 164876
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 168107
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075-6213
Country
United States
Facility Name
Diagnostic Group Integrated He /ID# 165195
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Arth and Osteo Clin Brazo Valley /ID# 165194
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Princess Alexandra Hospital /ID# 169239
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Emeritus Research /ID# 169240
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
UZ Gent /ID# 166017
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
ReumaClinic Genk /ID# 166018
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
UZ Leuven /ID# 166019
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Rheumatology Research Assoc /ID# 165240
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
University of Alberta - Division of Rheumatology /ID# 165239
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Credit Valley Rheumatology /ID# 200087
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Groupe de Recherche en Maladies Osseuses Inc /ID# 165238
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Clinical Hospital Dubrava /ID# 167049
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Medical Center Kuna-Peric /ID# 164851
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Revmatologicky ustav Praha /ID# 167004
City
Prague 2
State/Province
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Thomayerova nemocnice /ID# 167003
City
Prague 4
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
REVMACLINIC s.r.o. /ID# 167171
City
Brno
ZIP/Postal Code
611 41
Country
Czechia
Facility Name
ARTHROHELP, s.r.o. /ID# 167001
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Vejle Sygehus /ID# 165190
City
Vejle
State/Province
Syddanmark
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Helsinki Univ Central Hospital /ID# 165794
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Kiljava Medical Research /ID# 165793
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
CHU Bordeaux-Hopital Pellegrin /ID# 166309
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHRU Tours - Hopital Trousseau /ID# 165109
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
CHRU de Montpellier - Hôpital Lapeyronie /ID# 166308
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Rheumazentrum Ruhrgebiet /ID# 165148
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44649
Country
Germany
Facility Name
Kerckhoff Klinik GmbH /ID# 165158
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charite - Campus Benjamin Franklin Medizinische Klinik - Rheumatologie /ID# 165153
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 165146
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Revita Reumatologiai Rendelo /ID# 164724
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
University of Debrecen /ID# 165674
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Vita Verum Medical Bt. /ID# 165066
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 164741
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Ospedale Sant Orsola Malpighi /ID# 165692
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Policlinico Paolo Giaccone /Id# 165663
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
ASST G. Pini /ID# 165715
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O. Universitaria Senese /ID# 165716
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Hospital of the University of Occupational and Environmental Health /ID# 164380
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Gunma University Hospital /ID# 165683
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 164566
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Kagawa University Hospital /ID# 167517
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kochi Medical School Hospital /ID# 164460
City
Nankoku-shi
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Facility Name
Shinshu University Hospital /ID# 165304
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital /ID# 164376
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008607
Country
Japan
Facility Name
National Hospital Organization Osaka Minami Medical Center /ID# 164365
City
Kawachinagano-shi
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Osaka City University Hospital /ID# 165253
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Osaka University Hospital /ID# 166033
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University Hospital /ID# 164577
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0451
Country
Japan
Facility Name
Juntendo University Koshigaya Hospital /ID# 165809
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-0032
Country
Japan
Facility Name
Tokushima University Hospital /ID# 165108
City
Tokushima-shi
State/Province
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Juntendo University Hospital /ID# 164738
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
St.Luke's International Hospital /ID# 165219
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Daido Hospital /ID# 163886
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Okayama Saiseikai Outpatient Center Hospital /ID# 165595
City
Okayama
ZIP/Postal Code
700-0013
Country
Japan
Facility Name
Chungnam National University Hospital /ID# 164561
City
Jung-gu
State/Province
Daejeon Gwang Yeogsi
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center /ID# 165114
City
Incheon
State/Province
Incheon Gwang Yeogsi
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital /ID# 164541
City
Gwangju
State/Province
Jeonranamdo
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospi /ID# 165811
City
Seongdong-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Cath Univ Seoul St Mary's Hosp /ID# 164549
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital at Gangdong /ID# 164569
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 164557
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Universitair Medisch Centrum Groningen /ID# 165681
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden /ID# 166937
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Waikato Hospital /ID# 169242
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Middlemore Hospital /ID# 169241
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Osteo-Medic S.C. /ID# 165646
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
ETYKA-Osrodek Badan Klinicznyc /ID# 165634
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-117
Country
Poland
Facility Name
NZOZ Nasz Lekarz /ID# 166023
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Instituto Portugues De Reumatologia /ID# 168314
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Ocidental, EPE /ID# 168312
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 168313
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Hospital CUF Descobertas /ID# 168311
City
Lisbon
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Unidade Local De Saude Do Alto Minho /ID# 168310
City
Viana Do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 165028
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Parc de Salut del Mar /ID# 165027
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Corporac Sanitaria Parc Tauli /ID# 165029
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Skanes Universitetssjukhus /ID# 165712
City
Malmö
State/Province
Skane Lan
ZIP/Postal Code
214 28
Country
Sweden
Facility Name
Reumatologkliniken /ID# 165713
City
Vaesteras
ZIP/Postal Code
721 89
Country
Sweden
Facility Name
Warrington and Halton Hospitals NHS Foundation Trust /ID# 166202
City
Warrington
State/Province
Cheshire West And Chester
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
Whipps Cross Univ Hospital /ID# 165150
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Norfolk and Norwich Univ Hosp /ID# 165149
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Royal National Hosp for Rheuma /ID# 165147
City
Bath
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary /ID# 165152
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
31732180
Citation
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.
Results Reference
background
PubMed Identifier
34196498
Citation
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.
Results Reference
derived

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A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis

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