A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting (UpSPINE)

Effectiveness of Upadacitinib in Patients With Axial Spondyloarthritis Suffering From Typical Disease Activity and Pain in a Real-World Setting

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 Overview

• Status: Active, not recruiting
• Conditions: Axial Spondylarthritis (r-axSpA)
• Intervention / Treatment: Drug: Upadacitinib

• Study Type: Observational
• Enrollment (Actual): 338

Contacts and Locations

Study Locations

• Germany
  • Amberg, Germany, 92224
    • Marycz, Amberg, DE /ID# 240483
  • Augsburg, Germany, 86157
    • Rheumapraxis am Webereck /ID# 240454
  • Bad Bertrich, Germany, 56864
    • Praxis S. Bresgulewski /ID# 240662
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik /ID# 252219
  • Berlin, Germany, 12435
    • Rheumapraxis Berlin /ID# 242987
  • Berlin, Germany, 12555
    • Praxis Dr. med. Angela Seifert /ID# 245107
  • Berlin, Germany, 13055
    • Praxis Dr. Silke Zinke /ID# 240526
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede /ID# 268389
  • Braunschweig, Germany, 38100
    • Eisterhues, Braunschweig, DE /ID# 239438
  • Braunschweig, Germany, 38114
    • MVZ Herzogin Elisabeth Hospital /ID# 267983
  • Burglengenfeld, Germany, 93133
    • Dr. Walberer /ID# 249752
  • Coburg, Germany, 96450
    • Private Practice - Dr. Sebastian Schuh /ID# 240498
  • Cologne, Germany, 50996
    • Dres. Karger/Baerlecken /ID# 240442
  • Daun, Germany, 54550
    • MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839
  • Demmin, Germany, 17109
    • Kreiskrankenhaus Demmin /ID# 240451
  • Ehringshausen, Germany, 35630
    • Praxis Dilltal /ID# 240520
  • Erfurt, Germany, 99096
    • Private Practice - Dr. Daniel Bestler /ID# 251860
  • Freiberg, Germany, 09599
    • Michael Mueller, Freiberg, DE /ID# 240489
  • Gifhorn, Germany, 38518
    • Praxis Dres. Sensse/Sensse /ID# 240517
  • Hamburg, Germany, 22391
    • Private Practice - Dr. Hauke E. Heintz /ID# 254037
  • Hamburg, Germany, 22523
    • Dres. Weinhardt/Knobel/Doepfer /ID# 248195
  • Hanover, Germany, 30159
    • Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370
  • Hohen Neuendorf, Germany, 16540
    • Wernicke, Hohen Neuendorf, DE /ID# 250626
  • Jülich, Germany, 52428
    • Kremers, Juelich, DE /ID# 243357
  • Ludwigshafen, Germany, 67069
    • Dr. Bolze, Ludwigshafen, DE /ID# 251012
  • Mansfeld / Großörner, Germany, 06343
    • Praxis Dr. Annekatrin Rossbach /ID# 240495
  • Marktredwitz, Germany, 95615
    • Harmuth, Marktredwitz, DE /ID# 240455
  • Meerbusch, Germany, 40668
    • RHIO Forschungsinstitut /ID# 240525
  • Munich, Germany, 80935
    • Prof-med-stud.de /ID# 240458
  • Neubrandenburg, Germany, 17033
    • Praxis Dr. med Thilo Klopsch /ID# 240461
  • Nienburg, Germany, 31582
    • Praxis Hein & Gess /ID# 240456
  • Planegg, Germany, 82152
    • MVZ für Rheumatologie Dr. M. Welcker /ID# 240521
  • Plauen, Germany, 08523
    • Baumann & Lang, Plauen, DE /ID# 244369
  • Ratingen, Germany, 40882
    • Rheumazentrum Ratingen /ID# 240465
  • Seesen, Germany, 38723
    • Melzer, Seesen, DE /ID# 240484
  • Straubing, Germany, 94315
    • Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523
  • Ulm, Germany, 89073
    • Rheumathologie Ulm /ID# 240494
  • Waren, Germany, 17192
    • Praxis F. Schattenberg /ID# 257646
  • Wuppertal, Germany, 42105
    • Krankenhaus St. Josef /ID# 249747
  • Wuppertal, Germany, 42285
    • Praxis Barmen /ID# 240449
  • Wuppertal, Germany, 42285
    • Praxis Barmen /ID# 277515
  • Zwickau, Germany, 08060
    • Fricke-Wagner, Zwickau, DE /ID# 240452
  • Baden-Wurttemberg
    • Baden-Baden, Baden-Wurttemberg, Germany, 76530
      • ACURA Rheumazentrum Baden-Bade /ID# 249751
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Heilig, Heidelberg, DE /ID# 240492
    • Stuttgart, Baden-Wurttemberg, Germany, 70372
      • Rheumatologische Schwerpunktpraxis /ID# 245392
    • Tübingen, Baden-Wurttemberg, Germany, 72072
      • Praxis Dr. Haas /ID# 242982
    • Ulm, Baden-Wurttemberg, Germany, 89073
      • Praxis Dr. Rinaldi /ID# 242984
  • Brandenburg
    • Hoppegarten, Brandenburg, Germany, 15366
      • Praxis K. Pagel /ID# 240490
    • Potsdam, Brandenburg, Germany, 14467
      • Rheumahaus Studien GbR, Potsdam, DE /ID# 245231
    • Potsdam, Brandenburg, Germany, 14469
      • Praxis Dr. Sabine Reckert /ID# 245142
  • Lower Saxony
    • Bruchhausen-Vilsen, Lower Saxony, Germany, 27305
      • Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358
    • Hanover, Lower Saxony, Germany, 30161
      • Stille, Hanover, DE /ID# 252222
    • Hanover, Lower Saxony, Germany, 30173
      • Praxis. F. Bigdeli-Wilshusen /ID# 272904
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover /ID# 262814
    • Kassel, Lower Saxony, Germany, 34125
      • Rheumatologie Kassel /ID# 275998
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 51149
      • Krankenhaus Porz am Rhein /ID# 243765
    • Herne, North Rhine-Westphalia, Germany, 44649
      • Rheumazentrum Ruhrgebiet /ID# 240460
  • Rhineland-Palatinate
    • Kaiserslautern, Rhineland-Palatinate, Germany, 67659
      • Beyer, Kaiserslautern, DE /ID# 240444
    • Trier, Rhineland-Palatinate, Germany, 54292
      • Krankenhaus der Barmherzigen Brüder Trier /ID# 240524
  • Saarland
    • Homburg, Saarland, Germany, 66424
      • Praxis Bernd Mueller /ID# 240488
    • Püttlingen, Saarland, Germany, 66346
      • Rheumapraxis Dr. Prothmann /ID# 240671
  • Saxony
    • Chemnitz, Saxony, Germany, 09130
      • Medizinischen Versorgungszentrums Agilomed /ID# 240481
    • Dresden, Saxony, Germany, 01109
      • Rheumatologisches Medizinisches Versorgungszentrum Dresden /ID# 240516
    • Leipzig, Saxony, Germany, 04109
      • Hamann and Teich and Boche,Leipzig /ID# 240445
    • Leipzig, Saxony, Germany, 04129
      • Praxis internistische Rheumatologie /ID# 240515
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06128
      • Praxis Dr. Liebhaber /ID# 240480
    • Magdeburg, Saxony-Anhalt, Germany, 39104
      • Aurich and Sieburg, Magdeburg /ID# 240518
    • Naumburg, Saxony-Anhalt, Germany, 06618
      • Rheumatologische Facharztpraxis - Naumburg (Saale) /ID# 240477
  • Schleswig-Holstein
    • Rendsburg, Schleswig-Holstein, Germany, 24768
      • Rheumatologische Praxis Dr. Jochen Walter /ID# 250263
  • Thuringia
    • Altenburg, Thuringia, Germany, 04600
      • Kupka and Kupka, Altenburg, DE /ID# 240479
    • Erfurt, Thuringia, Germany, 99096
      • MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448
    • Weimar, Thuringia, Germany, 99427
      • Rheumapraxis Weimar /ID# 268387

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with axial spondylarthritis (axSpA) who have been prescribed upadacitinib in the course of routine practice according to relevant approved licenses.

Description

Inclusion Criteria:

• Clinical diagnosis of axSpA upon physician's judgement.
• Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
• Upadacitinib prescribed in accordance with the local label.

Exclusion Criteria:

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib).
• Participants with primary fibromyalgia (upon physician´s judgement)
• Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
• Participants who cannot be treated with upadacitinib according to the applicable local label.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants Receiving Upadacitinib.	Drug: Upadacitinib; Tablet; Oral; Other Names: RINVOQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Week 52
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.	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.	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.	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.	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).	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).	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.	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).	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.	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.	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.	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.	Week 4
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.	Up to Week 52
Percentage of Participants with Recurrence of Typical Extra-Musculoskeletal Manifestations (EMMs)	Participants with recurrence of typical extra-musculoskeletal manifestations (EMMs.	Up to Week 52
Percentage of Participants with new onset of typical EMMs	Participants with new onset of typical EMMs	Up to Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Upadacitinib; RINVOQ; Axial Spondylarthritis (axSpA)
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; upadacitinib
• Other Study ID Numbers: P21-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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