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

NCT05094128 | Active Not Recruiting

• 1 other identifier: P21-007
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 72

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.

Conditions

Axial Spondylarthritis (r-axSpA)

Keywords

Axial Spondylarthritis (axSpA); Upadacitinib; RINVOQ

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of 40

  Up to Week 52

• Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score < 4

  Up to Week 52

• Percentage of Participants Achieving ASDAS Inactive Disease (ID [< 1.3])

  Up to Week 52

• Percentage of Participants Achieving ASDAS LDA (< 2.1)

  Up to Week 52

• Change from Baseline in BASDAI

  Up to Week 52

Study Arms (1)

Participants Receiving Upadacitinib.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Tablet; Oral

Also known as: RINVOQ

Participants Receiving Upadacitinib.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (72)

ACURA Rheumazentrum Baden-Bade /ID# 249751

Baden-Baden, Baden-Wurttemberg, 76530, Germany

Location

Heilig, Heidelberg, DE /ID# 240492

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Rheumatologische Schwerpunktpraxis /ID# 245392

Stuttgart, Baden-Wurttemberg, 70372, Germany

Location

Praxis Dr. Haas /ID# 242982

Tübingen, Baden-Wurttemberg, 72072, Germany

Location

Praxis Dr. Rinaldi /ID# 242984

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Praxis K. Pagel /ID# 240490

Hoppegarten, Brandenburg, 15366, Germany

Location

Rheumahaus Studien GbR, Potsdam, DE /ID# 245231

Potsdam, Brandenburg, 14467, Germany

Location

Praxis Dr. Sabine Reckert /ID# 245142

Potsdam, Brandenburg, 14469, Germany

Location

Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358

Bruchhausen-Vilsen, Lower Saxony, 27305, Germany

Location

Stille, Hanover, DE /ID# 252222

Hanover, Lower Saxony, 30161, Germany

Location

Praxis. F. Bigdeli-Wilshusen /ID# 272904

Hanover, Lower Saxony, 30173, Germany

Location

Medizinische Hochschule Hannover /ID# 262814

Hanover, Lower Saxony, 30625, Germany

Location

Rheumatologie Kassel /ID# 275998

Kassel, Lower Saxony, 34125, Germany

Location

Krankenhaus Porz am Rhein /ID# 243765

Cologne, North Rhine-Westphalia, 51149, Germany

Location

Rheumazentrum Ruhrgebiet /ID# 240460

Herne, North Rhine-Westphalia, 44649, Germany

Location

Beyer, Kaiserslautern, DE /ID# 240444

Kaiserslautern, Rhineland-Palatinate, 67659, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier /ID# 240524

Trier, Rhineland-Palatinate, 54292, Germany

Location

Praxis Bernd Mueller /ID# 240488

Homburg, Saarland, 66424, Germany

Location

Rheumapraxis Dr. Prothmann /ID# 240671

Püttlingen, Saarland, 66346, Germany

Location

Medizinischen Versorgungszentrums Agilomed /ID# 240481

Chemnitz, Saxony, 09130, Germany

Location

Rheumatologisches Medizinisches Versorgungszentrum Dresden /ID# 240516

Dresden, Saxony, 01109, Germany

Location

Hamann and Teich and Boche,Leipzig /ID# 240445

Leipzig, Saxony, 04109, Germany

Location

Praxis internistische Rheumatologie /ID# 240515

Leipzig, Saxony, 04129, Germany

Location

Praxis Dr. Liebhaber /ID# 240480

Halle, Saxony-Anhalt, 06128, Germany

Location

Aurich and Sieburg, Magdeburg /ID# 240518

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Rheumatologische Facharztpraxis - Naumburg (Saale) /ID# 240477

Naumburg, Saxony-Anhalt, 06618, Germany

Location

Rheumatologische Praxis Dr. Jochen Walter /ID# 250263

Rendsburg, Schleswig-Holstein, 24768, Germany

Location

Kupka and Kupka, Altenburg, DE /ID# 240479

Altenburg, Thuringia, 04600, Germany

Location

MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448

Erfurt, Thuringia, 99096, Germany

Location

Rheumapraxis Weimar /ID# 268387

Weimar, Thuringia, 99427, Germany

Location

Marycz, Amberg, DE /ID# 240483

Amberg, 92224, Germany

Location

Rheumapraxis am Webereck /ID# 240454

Augsburg, 86157, Germany

Location

Praxis S. Bresgulewski /ID# 240662

Bad Bertrich, 56864, Germany

Location

Kerckhoff Klinik /ID# 252219

Bad Nauheim, 61231, Germany

Location

Rheumapraxis Berlin /ID# 242987

Berlin, 12435, Germany

Location

Praxis Dr. med. Angela Seifert /ID# 245107

Berlin, 12555, Germany

Location

Praxis Dr. Silke Zinke /ID# 240526

Berlin, 13055, Germany

Location

Krankenhaus Waldfriede /ID# 268389

Berlin, 14163, Germany

Location

Eisterhues, Braunschweig, DE /ID# 239438

Braunschweig, 38100, Germany

Location

MVZ Herzogin Elisabeth Hospital /ID# 267983

Braunschweig, 38114, Germany

Location

Dr. Walberer /ID# 249752

Burglengenfeld, 93133, Germany

Location

Private Practice - Dr. Sebastian Schuh /ID# 240498

Coburg, 96450, Germany

Location

Dres. Karger/Baerlecken /ID# 240442

Cologne, 50996, Germany

Location

MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839

Daun, 54550, Germany

Location

Kreiskrankenhaus Demmin /ID# 240451

Demmin, 17109, Germany

Location

Praxis Dilltal /ID# 240520

Ehringshausen, 35630, Germany

Location

Private Practice - Dr. Daniel Bestler /ID# 251860

Erfurt, 99096, Germany

Location

Michael Mueller, Freiberg, DE /ID# 240489

Freiberg, 09599, Germany

Location

Praxis Dres. Sensse/Sensse /ID# 240517

Gifhorn, 38518, Germany

Location

Private Practice - Dr. Hauke E. Heintz /ID# 254037

Hamburg, 22391, Germany

Location

Dres. Weinhardt/Knobel/Doepfer /ID# 248195

Hamburg, 22523, Germany

Location

Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370

Hanover, 30159, Germany

Location

Wernicke, Hohen Neuendorf, DE /ID# 250626

Hohen Neuendorf, 16540, Germany

Location

Kremers, Juelich, DE /ID# 243357

Jülich, 52428, Germany

Location

Dr. Bolze, Ludwigshafen, DE /ID# 251012

Ludwigshafen, 67069, Germany

Location

Praxis Dr. Annekatrin Rossbach /ID# 240495

Mansfeld / Großörner, 06343, Germany

Location

Harmuth, Marktredwitz, DE /ID# 240455

Marktredwitz, 95615, Germany

Location

RHIO Forschungsinstitut /ID# 240525

Meerbusch, 40668, Germany

Location

Prof-med-stud.de /ID# 240458

Munich, 80935, Germany

Location

Praxis Dr. med Thilo Klopsch /ID# 240461

Neubrandenburg, 17033, Germany

Location

Praxis Hein & Gess /ID# 240456

Nienburg, 31582, Germany

Location

MVZ für Rheumatologie Dr. M. Welcker /ID# 240521

Planegg, 82152, Germany

Location

Baumann & Lang, Plauen, DE /ID# 244369

Plauen, 08523, Germany

Location

Rheumazentrum Ratingen /ID# 240465

Ratingen, 40882, Germany

Location

Melzer, Seesen, DE /ID# 240484

Seesen, 38723, Germany

Location

Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523

Straubing, 94315, Germany

Location

Rheumathologie Ulm /ID# 240494

Ulm, 89073, Germany

Location

Praxis F. Schattenberg /ID# 257646

Waren, 17192, Germany

Location

Krankenhaus St. Josef /ID# 249747

Wuppertal, 42105, Germany

Location

Praxis Barmen /ID# 240449

Wuppertal, 42285, Germany

Location

Praxis Barmen /ID# 277515

Wuppertal, 42285, Germany

Location

Fricke-Wagner, Zwickau, DE /ID# 240452

Zwickau, 08060, Germany

Location

Related Links

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

MeSH Terms

Interventions

upadacitinib

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 26, 2021
• Study Start: November 22, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

DE (72)