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CompletedNCT03178487SELECT-AXIS 1Updated Mar 7, 2023Results posted

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

A Phase 2 interventional study of Upadacitinib and Placebo in Ankylosing Spondylitis (AS), sponsored by AbbVie. Completed at 101 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
187
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Ankylosing Spondylitis (AS)

Keywords

  • Upadacitinib
  • ABT-494
  • Ankylosing Spondylitis (AS)
  • Safety
  • Efficacy
03

In context

Spondylitis, Ankylosing

507 studies on the registry are indexed under Spondylitis, Ankylosing; 91 are open to participants now.

This study's enrollment of 187 is above the median of 84 across 281 interventional studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Browse AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
187 participants (actual)

Study arms

  • 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.

    Drug: Upadacitinib

  • 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.

    Drug: Upadacitinib · Drug: Placebo

Interventions

  • DrugUpadacitinib

    Tablet

    Also known as: ABT-494, RINVOQ™

  • DrugPlacebo

    Tablet

06

What researchers measure

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).

    Time frame: Baseline and Week 14

Secondary outcomes

  1. 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: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. 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

  2. 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.

    Time frame: Baseline and Week 14

  3. 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.

    Time frame: Baseline and Week 14

  4. 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.

    Time frame: Baseline and Week 14

  5. 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).

    Time frame: Week 14

  6. 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.

    Time frame: Baseline and Week 14

  7. 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: 1. cervical rotation (measured in degrees), 2. tragus to wall distance (in centimeters \[cm\]) 3. lumbar side flexion (in cm), 4. lumbar flexion (modified Schober's) (in cm) and 5. 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

  8. 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.

    Time frame: Baseline and Week 14

  9. 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.

    Time frame: Baseline and Week 14

  10. 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.

    Time frame: Baseline and Week 14

  11. 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).

    Time frame: Baseline and Week 14

  12. 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.

    Time frame: Baseline and Week 14

07

Results

Posted Jun 1, 2021

Participant flow

Participants were enrolled between October 24, 2017, and September 10, 2018 at 62 sites in 20 countries in North America, Eastern and Western Europe, Asia, and Oceania. This study consists of a 14-week double-blind treatment period (Period 1) and a 90-week long-term extension period (Period 2) for participants who completed Period 1.

Period 1
Participant flow — Period 1
MilestonePlacebo / Upadacitinib 15 mgUpadacitinib 15 mg
Started9493
Received treatment9493
Completed9089
Not completed44
Withdrew: Adverse event12
Withdrew: Withdrawal by subject21
Withdrew: Lost to follow-up10
Withdrew: Other01
Period 2
Participant flow — Period 2
MilestonePlacebo / Upadacitinib 15 mgUpadacitinib 15 mg
Started9089
Received treatment8989
Completed6970
Not completed2119
Withdrew: Adverse event44
Withdrew: Withdrawal by subject66
Withdrew: Lost to follow-up22
Withdrew: Coronavirus disease 2019 (covid-19) logistical restrictions10
Withdrew: Other87

Outcome measures

PrimaryPercentage 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).

Time frame:
Baseline and Week 14
Reported as:
Number · percentage of participants
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14
percentage of participantsPlaceboUpadacitinib 15 mg
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 1425.5 (16.7 to 34.3)51.6 (41.5 to 61.8)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Cochran-Mantel-Haenszel · p = <0.001 · Response rate difference: 26.1 · 95% CI 12.6 to 39.5Response Rate Difference = Upadacitinib - Placebo
SecondaryChange 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: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14-0.54 (-0.71 to -0.37)-1.45 (-1.62 to -1.28)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Mixed Effect Model Repeated Measurement · p = <0.001 · Least squares (ls) mean difference: -0.91 · 95% CI -1.14 to -0.68Treatment difference = Upadacitinib - Placebo
SecondaryChange 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.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14-0.22 (-2.01 to 1.57)-6.93 (-8.58 to -5.28)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · ANCOVA · p = <0.001 · Ls mean difference: -6.71 · 95% CI -9.01 to -4.41Treatment difference = Upadacitinib - Placebo
SecondaryPercentage 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.

Time frame:
Baseline and Week 14
Reported as:
Number · percentage of participants
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
percentage of participantsPlaceboUpadacitinib 15 mg
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 1423.4 (14.8 to 32.0)45.2 (35.0 to 55.3)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Cochran-Mantel-Haenszel · p = 0.002 · Response rate difference: 21.8 · 95% CI 8.5 to 35.0Response rate difference = Upadacitinib - Placebo
SecondaryChange 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.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score-2.67 (-3.58 to -1.75)-4.20 (-5.12 to -3.29)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Mixed Effect Model Repeated Measurement · p = 0.016 · Ls mean difference: -1.54 · 95% CI -2.78 to -0.30Treatment difference = Upadacitinib - Placebo
SecondaryPercentage 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).

Time frame:
Week 14
Reported as:
Number · percentage of participants
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission
percentage of participantsPlaceboUpadacitinib 15 mg
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission1.1 (0.0 to 3.1)19.4 (11.3 to 27.4)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Cochran-Mantel-Haenszel · p = <0.001 · Response rate difference: 18.3 · 95% CI 10.0 to 26.6Response rate difference = Upadacitinib - Placebo
SecondaryChange 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.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14-1.30 (-1.74 to -0.86)-2.29 (-2.73 to -1.85)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Mixed Effect Model Repeated Measurement · p = 0.001 · Ls mean difference: -1.00 · 95% CI -1.60 to -0.39Treatment difference = Upadacitinib - Placebo
SecondaryChange 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: 1. cervical rotation (measured in degrees), 2. tragus to wall distance (in centimeters \[cm\]) 3. lumbar side flexion (in cm), 4. lumbar flexion (modified Schober's) (in cm) and 5. 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
Reported as:
Least squares mean · score on a scale
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14-0.14 (-0.29 to 0.01)-0.37 (-0.52 to -0.21)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · ANCOVA · p = 0.030 · Ls mean difference: -0.22 · 95% CI -0.43 to -0.02Treatment difference = Upadacitinib - Placebo
SecondaryChange 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.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14-1.41 (-2.02 to -0.80)-2.25 (-2.86 to -1.64)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Mixed Effect Model Repeated Measurement · p = 0.049 · Ls mean difference: -0.84 · 95% CI -1.68 to -0.00Treatment difference = Upadacitinib - Placebo
SecondaryChange 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.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · percent impairment
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 14
percent impairmentPlaceboUpadacitinib 15 mg
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 14-12.60 (-19.04 to -6.15)-18.11 (-24.73 to -11.50)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · ANCOVA · p = 0.190 · Ls mean difference: -5.52 · 95% CI -13.82 to 2.78Treatment difference = Upadacitinib - Placebo
SecondaryChange 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.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in ASAS Health Index (HI) at Week 14
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in ASAS Health Index (HI) at Week 14-1.38 (-2.11 to -0.65)-2.75 (-3.48 to -2.02)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Mixed Effect Model Repeated Measurement · p = 0.007 (This comparison was not tested for statistical significance because the hierarchical testing procedures stopped during the Hochberg procedure.) · Ls mean difference: -1.37 · 95% CI -2.37 to -0.37Treatment difference = Upadacitinib - Placebo
SecondaryPercentage 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).

Time frame:
Baseline and Week 14
Reported as:
Number · percentage of participants
Percentage of Participants Achieving an ASAS 20 Response at Week 14
percentage of participantsPlaceboUpadacitinib 15 mg
Percentage of Participants Achieving an ASAS 20 Response at Week 1440.4 (30.5 to 50.3)64.5 (54.8 to 74.2)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · Cochran-Mantel-Haenszel · p = 0.001 (This comparison was not part of the pre-specified multiplicity testing sequence.) · Response rate difference: 24.1 · 95% CI 10.2 to 38.0Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.
SecondaryChange 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.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14-0.22 (-1.47 to 1.04)-3.91 (-5.05 to -2.77)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · ANCOVA · p = <0.001 (This comparison was not part of the pre-specified multiplicity testing sequence.) · Ls mean difference: -3.69 · 95% CI -5.31 to -2.08Treatment difference = Upadacitinib - Placebo
Post-hocChange From Baseline in SPARCC MRI Score for the Spine at Week 14 - Supplementary Analysis

In the SPARCC MRI assessment of the spine, the entire spine is evaluated for active inflammation (bone marrow edema). Six DVUs representing the 6 most abnormal DVUs were selected to calculate the SPARCC MRI spine score. For each DVU, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all dimensions. Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least 1 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. A supplemental post-hoc SPARCC MRI analysis included all MRI data collected at nominal visits at Baseline and Week 14.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in SPARCC MRI Score for the Spine at Week 14 - Supplementary Analysis
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in SPARCC MRI Score for the Spine at Week 14 - Supplementary Analysis-0.65 (-2.20 to 0.90)-6.86 (-8.41 to -5.30)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · ANCOVA · p = <0.001 · Ls mean difference: -6.21 · 95% CI -8.27 to -4.14Treatment difference = Upadacitinib - Placebo
Post-hocChange From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14 - Supplementary Analysis

In the SPARCC MRI assessment of the sacroiliac 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. A supplemental post-hoc SPARCC MRI analysis was done to include all MRI data collected at nominal visits at Baseline and Week 14.

Time frame:
Baseline and Week 14
Reported as:
Least squares mean · score on a scale
Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14 - Supplementary Analysis
score on a scalePlaceboUpadacitinib 15 mg
Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14 - Supplementary Analysis-0.90 (-2.01 to 0.20)-3.45 (-4.54 to -2.36)
Statistical analysis
  • Placebo vs Upadacitinib 15 mg · ANCOVA · p = <0.001 · Ls mean difference: -2.55 · 95% CI -4.01 to -1.08Treatment difference = Upadacitinib - Placebo

Adverse events

Collected over Period 1: From the first dose of study drug up to Week 14 or up to 30 days after last dose for participants who discontinued study drug prior to Week 14. Period 1+2: From Week 14 to 30 days after last dose (up to 94 weeks) for participants initially assigned to placebo; From Week 1 up to 30 days after last dose (up to 108 weeks) for participants initially assigned to upadacitinib.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Period 1: Placebo0/94 (0%)1/94 (1.1%)21/94 (22.3%)
Period 1: Upadacitinib 15 mg0/93 (0%)1/93 (1.1%)26/93 (28%)
Period 1 + 2: Upadacitinib 15 mg0/182 (0%)16/182 (8.8%)104/182 (57.1%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventPeriod 1: PlaceboPeriod 1: Upadacitinib 15 mgPeriod 1 + 2: Upadacitinib 15 mg
SPINAL OSTEOARTHRITISMusculoskeletal and connective tissue disorders0/941/931/182
CARDIOVASCULAR DISORDERCardiac disorders1/940/930/182
VERTIGO POSITIONALEar and labyrinth disorders0/940/931/182
APPENDICITIS NONINFECTIVEGastrointestinal disorders0/940/931/182
COLITISGastrointestinal disorders0/940/931/182
ANKLE FRACTUREInjury, poisoning and procedural complications0/940/931/182
FACIAL BONES FRACTUREInjury, poisoning and procedural complications0/940/931/182
MULTIPLE FRACTURESInjury, poisoning and procedural complications0/940/931/182
RADIUS FRACTUREInjury, poisoning and procedural complications0/940/931/182
BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations0/940/931/182
Most frequent other events
Most frequent other events
EventPeriod 1: PlaceboPeriod 1: Upadacitinib 15 mgPeriod 1 + 2: Upadacitinib 15 mg
NASOPHARYNGITISInfections and infestations4/945/9335/182
BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations2/948/9329/182
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations3/942/9323/182
HEADACHENervous system disorders2/945/9315/182
DIARRHOEAGastrointestinal disorders5/945/9313/182
ALANINE AMINOTRANSFERASE INCREASEDInvestigations2/945/9313/182
ANKYLOSING SPONDYLITISMusculoskeletal and connective tissue disorders4/940/9313/182
BACK PAINMusculoskeletal and connective tissue disorders4/941/9311/182
NAUSEAGastrointestinal disorders5/941/936/182

Baseline characteristics

The full analysis set (FAS) includes all randomized participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)PlaceboUpadacitinib 15 mgTotal
Mean43.7 ± 12.0747.0 ± 12.7845.4 ± 12.50
Age, Customized
Age, Customized(Participants)PlaceboUpadacitinib 15 mgTotal
< 40 years392867
40 - 64 years5356109
≥ 65 years2911
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboUpadacitinib 15 mgTotal
Female253055
Male6963132
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboUpadacitinib 15 mgTotal
Hispanic or Latino549
Not Hispanic or Latino8989178
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboUpadacitinib 15 mgTotal
White7679155
Black or African American213
Asian161329
Region
Region(Participants)PlaceboUpadacitinib 15 mgTotal
USA and Canada10919
Western Europe333063
Eastern Europe343670
Japan7613
South Korea7613
Australia and New Zealand369
Duration Since Ankylosing Spondylitis (AS) Diagnosis
Duration Since Ankylosing Spondylitis (AS) Diagnosis(years)PlaceboUpadacitinib 15 mgTotal
Mean6.0 ± 6.797.8 ± 10.646.9 ± 8.94
Duration of Ankylosing Spondylitis Symptoms
Duration of Ankylosing Spondylitis Symptoms(years)PlaceboUpadacitinib 15 mgTotal
Mean14.0 ± 9.8614.8 ± 11.6414.4 ± 10.76

5 further baseline measures are reported on the registry.

08

Study locations

101 sites
  • 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
    Malmö, 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

Showing the first 100 of 101 sites across 21 countries.

09

References and documents

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. PubMed 31732180 ↗
  • Baraliakos X, Bessette L, de Vlam K, Taylor PC, Biljan A, Urbanik J, Gao T, Jasion VS, Kato K, Lippe R, Magrey M. Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies. Rheumatol Ther. 2026 Jun;13(3):611-628. doi: 10.1007/s40744-026-00834-5. Epub 2026 Mar 13. PubMed 41824252 ↗
  • Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2. PubMed 41039829 ↗
  • Burmester 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. PubMed 40875187 ↗
  • Navarro-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. PubMed 40037923 ↗
  • Poddubnyy D, Parikh B, Elewaut D, Navarro-Compan V, Siebert S, Paley M, Coombs D, Lagunes I, Biljan A, Nakasato P, Wung P, Lubrano E. Development of Extramusculoskeletal Manifestations in Upadacitinib-Treated Patients With Psoriatic Arthritis or Axial Spondyloarthritis. Arthritis Rheumatol. 2025 May;77(5):536-546. doi: 10.1002/art.43069. Epub 2025 Jan 24. PubMed 39624020 ↗
  • Burmester 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. PubMed 38683479 ↗
  • Rubbert-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. PubMed 37982966 ↗
  • Charles-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. PubMed 37945286 ↗
  • Burmester 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. PubMed 36754548 ↗
  • 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. PubMed 34196498 ↗

Study documents

  • Study protocol · Dec 20, 2019
  • Statistical analysis plan · Aug 20, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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/

Data sharing details ↗ · vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jan 2019, 14 months.

Results were first posted in Jun 2021, 2 years 4 months after primary completion. A results delay was requested in Nov 2019.

Of 21 phase 2 interventional studies under Spondylitis, Ankylosing, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 14 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2017
First posted
Jun 7, 2017
StartActual
Oct 24, 2017
Primary completionActual
Jan 21, 2019
CompletionActual
Feb 17, 2022
Results delay requested
Nov 12, 2019
Results first posted
Jun 1, 2021
Last update
Mar 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03178487
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jun 7, 2017
Start date
Oct 24, 2017
Primary completion
Jan 21, 2019
Completion
Feb 17, 2022
Results posted
Jun 1, 2021
Last update
Mar 7, 2023

Study contacts

AbbVie Inc.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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