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 that might be difficult to distinguish from other causes of chronic back pain. Many participants report persistent pain, including back pain, which impacts disease activity and and impairs quality of life while evoking typical disease burden such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained disease control, and the association between pain and clinical/patient-reported outcomes in axSpA participants. Upadacitinib is being developed for the treatment of axSpA. Approximately 352 adult participants with active axSpA will be enrolled in Germany. 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 52 weeks. There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. 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.
Study Type
OBSERVATIONAL
Enrollment
352
Tablet; Oral
ACURA Rheumazentrum Baden-Bade /ID# 249751
Baden-Baden, Baden-Wurttemberg, Germany
RECRUITINGHeilig, Heidelberg, DE /ID# 240492
Heidelberg, Baden-Wurttemberg, Germany
ACTIVE_NOT_RECRUITINGRheumatologische Schwerpunktpraxis /ID# 245392
Stuttgart, Baden-Wurttemberg, Germany
RECRUITINGPraxis Dr. Haas /ID# 242982
Tübingen, Baden-Wurttemberg, Germany
Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1])
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.
Time frame: Week 24
Percentage of Participants Achieving ASDAS LDA (< 2.1) (i.e., Maintenance of Response)
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. Maintenance of response is defined as those achieving LDA at Week 24 and Week 52.
Time frame: Up to Week 52
Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of 40
The ASAS-HI has been developed to measure functioning and health in participants with SpA with the aim of defining and comparing the impact of the disease and health based on the biopsychosocial model of disease proposed by the International Classification of Functioning, Disability and Health (ICF).
Time frame: Up to Week 52
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score < 4
The BASDAI is a commonly used measure to define disease activity levels in axSpA participants. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.
Time frame: Up to Week 52
Percentage of Participants Achieving ASDAS Inactive Disease (ID [< 1.3])
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.
Time frame: Up to Week 52
Percentage of Participants Achieving ASDAS LDA (< 2.1)
The ASDAS is a composite index with proven validity and reliability to assess disease activity in axSpA participants, with LDA defined as a score \< 2.1.
Time frame: Up to Week 52
Change from Baseline in BASDAI
The BASDAI is a commonly used measure to define disease activity levels in axSpA participants. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.
Time frame: Up to Week 52
Change from Baseline in BASDAI at Week 1-4
The BASDAI is a commonly used measure to define disease activity levels in axSpA participants. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.
Time frame: Week 4
Percentage of Participants with Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) for Participants with Baseline Enthesitis
The LEI is a clinical index used to assess enthesitis. It consists of 3 bilateral sites: Achilles tendon insertions, medial femoral condyles, and lateral epicondyles of the humerus. Tenderness at each site is quantified on a dichotomous basis: 0 means nontender and 1 means tender.
Time frame: Up to Week 52
Percentage of Participants with Resolution of Dactylitis for Participants with Baseline Dactylitis
Presence of dactylitis (Yes/No) will be assessed by the physician.
Time frame: Up to Week 52
Mean Change from Baseline in ASAS-HI
The ASAS-HI has been developed to measure functioning and health in patients with SpA with the aim of defining and comparing the impact of the disease and health based on the biopsychosocial model of disease proposed by the ICF.
Time frame: Up to Week 52
Percentage of Participants with ASAS-HI <= 4
The ASAS-HI has been developed to measure functioning and health in patients with SpA with the aim of defining and comparing the impact of the disease and health based on the biopsychosocial model of disease proposed by the ICF.
Time frame: Up to Week 52
Mean Change from Baseline in Nocturnal Back Pain in Past 24 Hours
Pain will be measured using a 0 - 10 numerical rating scale (NRS) for nocturnal back pain (0 = no pain and 10 = most severe pain).
Time frame: Up to Week 52
Mean Change from Baseline in Total Back Pain in Past 24 Hours
Pain will be measured using a 0 - 10 numerical rating scale (NRS) for nocturnal back pain (0 = no pain and 10 = most severe pain).
Time frame: Up to Week 52
Mean Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The BASFI is a validated PRO instrument for use in the 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 axSpA participants 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 axSpA participants.
Time frame: Up to Week 52
Mean Change from Baseline in Patient Health Questionnaire-4 (PHQ-4)
The 4-item PHQ-4 is an ultra-brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). It is rated on a 4-point Likert-type scale. Its purpose is to allow for very brief and accurate measurement of depression and anxiety.
Time frame: Up to Week 52
Percentage of Participants with Recurrence of Typical Extra-Musculoskeletal Manifestations (EMMs)
Participants with recurrence of typical extra-musculoskeletal manifestations (EMMs.
Time frame: Up to Week 52
Percentage of Participants with new onset of typical EMMs
Participants with new onset of typical EMMs
Time frame: Up to Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Praxis Dr. Rinaldi /ID# 242984
Ulm, Baden-Wurttemberg, Germany
ACTIVE_NOT_RECRUITINGPraxis K. Pagel /ID# 240490
Hoppegarten, Brandenburg, Germany
ACTIVE_NOT_RECRUITINGRheumahaus Studien GbR, Potsdam, DE /ID# 245231
Potsdam, Brandenburg, Germany
ACTIVE_NOT_RECRUITINGPraxis Dr. Sabine Reckert /ID# 245142
Potsdam, Brandenburg, Germany
RECRUITINGFachpraxis fuer Rheumatologie und Osteologie /ID# 243358
Bruchhausen-Vilsen, Lower Saxony, Germany
ACTIVE_NOT_RECRUITINGStille, Hanover, DE /ID# 252222
Hanover, Lower Saxony, Germany
ACTIVE_NOT_RECRUITING...and 62 more locations