Clinical trial NCT05094128: A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting
Official title: Effectiveness of Upadacitinib in Patients With Axial Spondyloarthritis Suffering From Typical Disease Activity and Pain in a Real-World Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Axial Spondylarthritis (r-axSpA)
Keywords: Axial Spondylarthritis (axSpA)
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1])
timeFrame: Week 24
measure: Percentage of Participants Achieving ASDAS LDA (< 2.1) (i.e., Maintenance of Response)
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of 40
timeFrame: Up to Week 52
measure: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score < 4
timeFrame: Up to Week 52
measure: Percentage of Participants Achieving ASDAS Inactive Disease (ID [< 1.3])
timeFrame: Up to Week 52
measure: Percentage of Participants Achieving ASDAS LDA (< 2.1)
timeFrame: Up to Week 52
measure: Change from Baseline in BASDAI
timeFrame: Up to Week 52
measure: Change from Baseline in BASDAI at Week 1-4
timeFrame: Week 4
measure: Percentage of Participants with Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) for Participants with Baseline Enthesitis
timeFrame: Up to Week 52
measure: Percentage of Participants with Resolution of Dactylitis for Participants with Baseline Dactylitis
timeFrame: Up to Week 52
measure: Mean Change from Baseline in ASAS-HI
timeFrame: Up to Week 52
measure: Percentage of Participants with ASAS-HI <= 4
timeFrame: Up to Week 52
measure: Mean Change from Baseline in Nocturnal Back Pain in Past 24 Hours
timeFrame: Up to Week 52
measure: Mean Change from Baseline in Total Back Pain in Past 24 Hours
timeFrame: Up to Week 52
measure: Mean Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Up to Week 52
measure: Mean Change from Baseline in Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Up to Week 52
measure: Percentage of Participants with Recurrence of Typical Extra-Musculoskeletal Manifestations (EMMs)
timeFrame: Up to Week 52
measure: Percentage of Participants with new onset of typical EMMs
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Baden-baden
country: Germany
facility: ACURA Rheumazentrum Baden-Bade /ID# 249751
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: Heilig, Heidelberg, DE /ID# 240492
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Rheumatologische Schwerpunktpraxis /ID# 245392
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Praxis Dr. Haas /ID# 242982
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Praxis Dr. Rinaldi /ID# 242984
state: Baden-Wuerttemberg
city: Hoppegarten
country: Germany
facility: Praxis K. Pagel /ID# 240490
state: Brandenburg
city: Potsdam
country: Germany
facility: Rheumahaus Studien GbR, Potsdam, DE /ID# 245231
state: Brandenburg
city: Potsdam
country: Germany
facility: Praxis Dr. Sabine Reckert /ID# 245142
state: Brandenburg
city: Bruchhausen-Vilsen
country: Germany
facility: Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358
state: Niedersachsen
city: Hannover
country: Germany
facility: Stille, Hanover, DE /ID# 252222
state: Niedersachsen
city: Hanover
country: Germany
facility: Praxis. F. Bigdeli-Wilshusen /ID# 272904
state: Niedersachsen
city: Kassel
country: Germany
facility: Rheumatologie Kassel /ID# 275998
state: Niedersachsen
city: Cologne
country: Germany
facility: Krankenhaus Porz am Rhein /ID# 243765
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 240460
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
facility: Beyer, Kaiserslautern, DE /ID# 240444
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier /ID# 240524
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Praxis Bernd Mueller /ID# 240488
state: Saarland
city: Püttlingen
country: Germany
facility: Rheumapraxis Dr. Prothmann /ID# 240671
state: Saarland
city: Halle
country: Germany
facility: Praxis Dr. Liebhaber /ID# 240480
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Aurich & Sieburg, Magdeburg /ID# 240518
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Med Versorgungszentrum AGILOMED /ID# 240481
state: Sachsen
city: Leipzig
country: Germany
facility: Hamann & Teich & Boche,Leipzig /ID# 240445
state: Sachsen
city: Leipzig
country: Germany
facility: Praxis internistische Rheumatologie /ID# 240515
state: Sachsen
city: Rendsburg
country: Germany
facility: Rheumatologische Praxis Dr. Jochen Walter /ID# 250263
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448
state: Thueringen
city: Weimar
country: Germany
facility: Rheumapraxis Weimar /ID# 268387
state: Thueringen
city: Altenburg
country: Germany
facility: Kupka & Kupka, Altenburg, DE /ID# 240479
city: Amberg
country: Germany
facility: Marycz, Amberg, DE /ID# 240483
city: Augsburg
country: Germany
facility: Rheumapraxis am Webereck /ID# 240454
city: Bad Bertrich
country: Germany
facility: Praxis S. Bresgulewski /ID# 240662
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik /ID# 252219
city: Berlin
country: Germany
facility: Rheumapraxis Berlin /ID# 242987
city: Berlin
country: Germany
facility: Praxis Dr. med. Angela Seifert /ID# 245107
city: Berlin
country: Germany
facility: Praxis Dr. Silke Zinke /ID# 240526
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede /ID# 268389
city: Braunschweig
country: Germany
facility: Eisterhues, Braunschweig, DE /ID# 239438
city: Brunswick
country: Germany
facility: MVZ Herzogin Elisabeth Hospital /ID# 267983
city: Burglengenfeld
country: Germany
facility: Dr. Walberer /ID# 249752
city: Coburg
country: Germany
facility: Dres. Schuh /ID# 240498
city: Cologne
country: Germany
facility: Dres. Karger/Baerlecken /ID# 240442
city: Daun
country: Germany
facility: MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839
city: Demmin
country: Germany
facility: Kreiskrankenhaus Demmin /ID# 240451
city: Dresden
country: Germany
facility: Rheumatologisches MVZ Dresden /ID# 240516
city: Ehringshausen
country: Germany
facility: Praxis Dilltal /ID# 240520
city: Erfurt
country: Germany
facility: Dr. Bestler /ID# 251860
city: Freiberg
country: Germany
facility: Michael Mueller, Freiberg, DE /ID# 240489
city: Gifhorn
country: Germany
facility: Praxis Dres. Sensse/Sensse /ID# 240517
city: Hamburg
country: Germany
facility: Dr. Heintz /ID# 254037
city: Hamburg
country: Germany
facility: Dres. Weinhardt/Knobel/Doepfer /ID# 248195
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 262814
city: Hanover
country: Germany
facility: Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370
city: Hohen Neuendorf
country: Germany
facility: Wernicke, Hohen Neuendorf, DE /ID# 250626
city: Juelich
country: Germany
facility: Kremers, Juelich, DE /ID# 243357
city: Ludwigshafen
country: Germany
facility: Dr. Bolze, Ludwigshafen, DE /ID# 251012
city: Mansfeld / Großörner
country: Germany
facility: Praxis Dr. Annekatrin Rossbach /ID# 240495
city: Marktredwitz
country: Germany
facility: Harmuth, Marktredwitz, DE /ID# 240455
city: Meerbusch
country: Germany
facility: RHIO Forschungsinstitut /ID# 240525
city: Munich
country: Germany
facility: Prof-med-stud.de /ID# 240458
city: Naumburg (Saale)
country: Germany
facility: Rheumatologische Facharztpraxis /ID# 240477
city: Neubrandenburg
country: Germany
facility: Praxis Dr. med Thilo Klopsch /ID# 240461
city: Nienburg
country: Germany
facility: Praxis Hein & Gess /ID# 240456
city: Planegg
country: Germany
facility: MVZ für Rheumatologie Dr. M. Welcker /ID# 240521
city: Plauen
country: Germany
facility: Baumann & Lang, Plauen, DE /ID# 244369
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen /ID# 240465
city: Seesen
country: Germany
facility: Melzer, Seesen, DE /ID# 240484
city: Straubing
country: Germany
facility: Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523
city: Ulm
country: Germany
facility: Rheumathologie Ulm /ID# 240494
city: Waren (Müritz)
country: Germany
facility: Praxis F. Schattenberg /ID# 257646
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef /ID# 249747
city: Wuppertal
country: Germany
facility: Praxis Barmen /ID# 240449
city: Zwickau
country: Germany
facility: Fricke-Wagner, Zwickau, DE /ID# 240452
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: