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A Study of the Change in Early and Sustained Pain Control in Radiographic Axial Spondylarthritis in Adult Participants Receiving Upadacitinib (UPSTAND)

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ClinicalTrials.gov Identifier: NCT04846244
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. Despite this, there is a lack of detailed data and knowledge on pain in radiographic-axial spondyloarthritis (r-axSpA), including pain types, how it is localized, and how these different facets of pain are impacted by treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in radiographic axSpA participants.

Upadacitinib is being developed for the treatment of r-axSpA. Approximately 877 adult participants with activer-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 30 months.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Condition or disease
Radiographic Axial Spondylarthritis (r-axSpA)

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Study Type : Observational
Estimated Enrollment : 877 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Radiographic Axial Spondylarthritis (UPSTAND)
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Participants Receiving Upadacitinib
Participants receiving Upadacitinib for radiographic axial spondyloarthritis (r-axSpA).



Primary Outcome Measures :
  1. Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement [ Time Frame: Baseline (Week 0) to Week 12 ]
    Total spinal pain consists of the mean of two 0-10 numerical rating scale (NRS) questions: total back pain during the previous week and nocturnal back pain during the previous week.

  2. Percentage of Participants Maintaining Total Spinal Pain < 4 Among Participants Who Achieved Total Spinal Pain < 4 and >= 2 unit (0 - 10) Improvement from Baseline at Week 12 [ Time Frame: Week 52 ]
    Total spinal pain score consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.


Secondary Outcome Measures :
  1. Change in Participant's Assessment of Total Spinal Pain [ Time Frame: Baseline to Week 52 ]
    Total spinal pain consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.

  2. Change in Patient's Assessment of Total Back Pain NRS [ Time Frame: Baseline (Week 0) to Week 52 ]
    Pain will be measured using a 0 - 10 numerical rating scale (NRS) for total back pain (0 = no pain and 10 = most severe pain).

  3. Change in Patient's Assessment of Nocturnal Back Pain NRS [ Time Frame: Baseline (Week 0) to Week 52 ]
    Pain will be measured using a 0 - 10 numerical rating scale (NRS) for nocturnal back pain (0 = no pain and 10 = most severe pain).

  4. Change in painDETECT Questionnaire (PD-Q) Score [ Time Frame: Baseline (Week 0) to Week 52 ]
    The PD-Q is a patient-based questionnaire used to determine the prevalence of neuropathic pain components in low back pain participants. Scores range from -1 to 38, with higher scores indicating a greater likelihood of the participant's pain having a neuropathic component.

  5. Change in Widespread Pain Index (WPI) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The WPI quantifies the extent of bodily pain on a 0 to 19 scale by asking participants if they have had pain or tenderness in 19 different body regions (shoulder girdle, hip, jaw, upper arm, upper leg, lower arm, and lower leg on each side of the body, as well as upper back, lower back, chest, neck, and abdomen) over the past week, with each painful or tender region scoring 1 point.

  6. Percentage of Participants Achieving Pittsburgh Sleep Quality Index (PSQI) score < 5 [ Time Frame: Up to Week 52 ]
    The PSQI consists of 19 individual items across 7 components: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component is scored from 0 (no difficulty) to 3 (severe difficulty) and summed to produce a total global score (range 0 to 21). A score of less than 5 is indicative of no clinical sleep impairment

  7. Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity .[ASDAS LDA (< 2.1)] [ Time Frame: Up to Week 52 ]
    The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Low disease is defined as an ASDAS < 2.1.

  8. Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Inactive Disease [ASDAS ID (<1.3)] [ Time Frame: Up to Week 52 ]
    The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Inactive disease is defined as an ASDAS < 1.3.

  9. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The BASDAI consists of 6 questions on a 0 to 10 NRS (0 being no problem and 10 being very severe problems) pertaining to the 5 major symptoms of r-axSpA: fatigue, spinal pain, peripheral joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.

  10. Change in 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The SF-12 is a generic health-related QoL instrument consisting of a subset of 12 questions from the 36-Item Short Form Health Survey (SF-36). It assesses quality of life (QoL) across 8 domains: physical functioning, role physical, role emotional, social functioning, bodily pain, vitality, mental health, and general health. The SF-12 is used to derive the PCS with higher scores indicating a higher QoL.

  11. Change in 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The SF-12 is a generic health-related QoL instrument consisting of a subset of 12 questions from the 36-Item Short Form Health Survey (SF-36). It assesses quality of life (QoL) across 8 domains: physical functioning, role physical, role emotional, social functioning, bodily pain, vitality, mental health, and general health. The SF-12 is used to derive the MCS with higher scores indicating a higher QoL.

  12. Percentage of Participants Achieving [Hospital Anxiety and Depression Scale (HADS) score <= 7] for a participants with HADS score > 7 at Baseline [ Time Frame: Up to Week 52 ]
    The HADS assesses participant mental health status (consists of anxiety [Hospital Anxiety and Depression Scale-Anxiety (HADS-A)] and depression [Hospital Anxiety and Depression Scale-Depression (HADS-D)] subscales). The range for both subscales is 0 - 21, with 0 - 7 = normal, 8 - 10 = borderline abnormal, and 11 - 21 = abnormal.

  13. Change in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The BASFI is a validated patient-reported outcome (PRO) instrument for use in the r-axSpA participant population. It consists of 10 items measured on a 0 to 10 NRS, which assesses the ability to perform activities known to be problematic to r-axSpA patients such as dressing, bending, reaching, turning, and climbing steps. The total scores range from 0 to 10 with higher scores indicating worse physical functioning in r-axSpA participants.

  14. Change in ASDAS [ Time Frame: Baseline (Week 0) to Week 52 ]
    The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).

  15. Change in C-Reactive Protein (CRP) [ Time Frame: Baseline (Week 0) to Week 52 ]
    Change in CRP.

  16. Percentage of Participants with Discontinuation of Nonsteroidal Anti-Inflammatory Drug (NSAID) Among Participants using NSAIDs at Baseline [ Time Frame: Up to Week 52 ]
    Discontinuation of NSAID among participants using NSAIDs at Baseline.

  17. Percentage of Participants using NSAIDs as Needed or Continuously [ Time Frame: Baseline (Week 0) to Week 52 ]
    Percentage of participants using NSAIDs as needed or continuously.

  18. Change in Total Daily Dose of NSAIDs [ Time Frame: Baseline (Week 0) to Week 52 ]
    Change in total daily dose of NSAIDs.

  19. Percentage of Participants Achieving Enthesitis Resolution [Maastricht Ankylosing Spondylitis Enthesitis Score (MASES = 0)] among Participants with any Enthesitis (MASES ≥ 1) at Baseline [ Time Frame: Baseline (Week 0) to Week 52 ]
    The MASES evaluates the presence or absence of enthesitis 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).

  20. Percentage of Participants with New Onset of Extra-articular Manifestations (EAMs) Among Participants with no History of EAMs [ Time Frame: Up to Week 52 ]
    Percentage of participants with new onset for participants with no history of EAMs (e.g., uveitis and inflammatory bowel disease [IBD]).

  21. Percentage of Participants with Recurrence of EAMs among Participants with Previous History of EAMs [ Time Frame: Up to Week 52 ]
    Percentage of participants with recurrence for participants with previous history of EAMs (e.g., uveitis and IBD).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with Radiographic Axial Spondylarthritis (r-axSpA) who have been prescribed upadacitinib in the course of routine practice according to relevant approved licenses.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Radiographic Axial Spondylarthritis (r-axSpA) and meeting the modified New York Criteria for r-axSpA.
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at Baseline.
  • Total back pain score ≥ 4 at Baseline.
  • 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 contraindication for NSAIDs as defined by the investigator.
  • Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor.
  • Participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis.
  • Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
  • Unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires.
  • Participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications).
  • Vulnerable or protected adult patients with lack of capability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846244


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04846244    
Other Study ID Numbers: P20-410
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Radiographic Axial Spondylarthritis (r-axSpA)
Upadacitinib
RINVOQ
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Bone Diseases, Infectious
Infections