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Real-World study tests upadacitinib for back pain in axial spondyloarthritis

NCT ID NCT05094128

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how well upadacitinib (RINVOQ) works for people with axial spondyloarthritis, a type of inflammatory arthritis that causes chronic back pain. About 338 adults in Germany will take the drug as prescribed by their doctor and be followed for 52 weeks. Researchers will measure disease activity and pain control using standard questionnaires and blood tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib (RINVOQ)
What this could lead to
If successful, this study could show that upadacitinib effectively controls disease activity and reduces pain in people with axial spondyloarthritis in everyday clinical settings.
What could go wrong
This is an observational real-world study, not a controlled trial, so results may be less definitive. Upadacitinib is already approved, so this is about confirming effectiveness rather than a breakthrough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

338 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial spondylarthritis (R-axspa)

Contacts and locations

Locations

  • ACURA Rheumazentrum Baden-Bade /ID# 249751

    Baden-Baden, Baden-Wurttemberg, 76530, Germany

  • Aurich and Sieburg, Magdeburg /ID# 240518

    Magdeburg, Saxony-Anhalt, 39104, Germany

  • Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523

    Straubing, 94315, Germany

  • Baumann & Lang, Plauen, DE /ID# 244369

    Plauen, 08523, Germany

  • Beyer, Kaiserslautern, DE /ID# 240444

    Kaiserslautern, Rhineland-Palatinate, 67659, Germany

  • Dr. Bolze, Ludwigshafen, DE /ID# 251012

    Ludwigshafen, 67069, Germany

  • Dr. Walberer /ID# 249752

    Burglengenfeld, 93133, Germany

  • Dres. Karger/Baerlecken /ID# 240442

    Cologne, 50996, Germany

  • Dres. Weinhardt/Knobel/Doepfer /ID# 248195

    Hamburg, 22523, Germany

  • Eisterhues, Braunschweig, DE /ID# 239438

    Braunschweig, 38100, Germany

  • Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358

    Bruchhausen-Vilsen, Lower Saxony, 27305, Germany

  • Fricke-Wagner, Zwickau, DE /ID# 240452

    Zwickau, 08060, Germany

  • Hamann and Teich and Boche,Leipzig /ID# 240445

    Leipzig, Saxony, 04109, Germany

  • Harmuth, Marktredwitz, DE /ID# 240455

    Marktredwitz, 95615, Germany

  • Heilig, Heidelberg, DE /ID# 240492

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Kerckhoff Klinik /ID# 252219

    Bad Nauheim, 61231, Germany

  • Krankenhaus Porz am Rhein /ID# 243765

    Cologne, North Rhine-Westphalia, 51149, Germany

  • Krankenhaus St. Josef /ID# 249747

    Wuppertal, 42105, Germany

  • Krankenhaus Waldfriede /ID# 268389

    Berlin, 14163, Germany

  • Krankenhaus der Barmherzigen Brüder Trier /ID# 240524

    Trier, Rhineland-Palatinate, 54292, Germany

  • Kreiskrankenhaus Demmin /ID# 240451

    Demmin, 17109, Germany

  • Kremers, Juelich, DE /ID# 243357

    Jülich, 52428, Germany

  • Kupka and Kupka, Altenburg, DE /ID# 240479

    Altenburg, Thuringia, 04600, Germany

  • MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448

    Erfurt, Thuringia, 99096, Germany

  • MVZ Herzogin Elisabeth Hospital /ID# 267983

    Braunschweig, 38114, Germany

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

    Planegg, 82152, Germany

  • MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839

    Daun, 54550, Germany

  • Marycz, Amberg, DE /ID# 240483

    Amberg, 92224, Germany

  • Medizinische Hochschule Hannover /ID# 262814

    Hanover, Lower Saxony, 30625, Germany

  • Medizinischen Versorgungszentrums Agilomed /ID# 240481

    Chemnitz, Saxony, 09130, Germany

  • Melzer, Seesen, DE /ID# 240484

    Seesen, 38723, Germany

  • Michael Mueller, Freiberg, DE /ID# 240489

    Freiberg, 09599, Germany

  • Praxis Barmen /ID# 240449

    Wuppertal, 42285, Germany

  • Praxis Barmen /ID# 277515

    Wuppertal, 42285, Germany

  • Praxis Bernd Mueller /ID# 240488

    Homburg, Saarland, 66424, Germany

  • Praxis Dilltal /ID# 240520

    Ehringshausen, 35630, Germany

  • Praxis Dr. Annekatrin Rossbach /ID# 240495

    Mansfeld / Großörner, 06343, Germany

  • Praxis Dr. Haas /ID# 242982

    Tübingen, Baden-Wurttemberg, 72072, Germany

  • Praxis Dr. Liebhaber /ID# 240480

    Halle, Saxony-Anhalt, 06128, Germany

  • Praxis Dr. Rinaldi /ID# 242984

    Ulm, Baden-Wurttemberg, 89073, Germany

  • Praxis Dr. Sabine Reckert /ID# 245142

    Potsdam, Brandenburg, 14469, Germany

  • Praxis Dr. Silke Zinke /ID# 240526

    Berlin, 13055, Germany

  • Praxis Dr. med Thilo Klopsch /ID# 240461

    Neubrandenburg, 17033, Germany

  • Praxis Dr. med. Angela Seifert /ID# 245107

    Berlin, 12555, Germany

  • Praxis Dres. Sensse/Sensse /ID# 240517

    Gifhorn, 38518, Germany

  • Praxis F. Schattenberg /ID# 257646

    Waren, 17192, Germany

  • Praxis Hein & Gess /ID# 240456

    Nienburg, 31582, Germany

  • Praxis K. Pagel /ID# 240490

    Hoppegarten, Brandenburg, 15366, Germany

  • Praxis S. Bresgulewski /ID# 240662

    Bad Bertrich, 56864, Germany

  • Praxis internistische Rheumatologie /ID# 240515

    Leipzig, Saxony, 04129, Germany

  • Praxis. F. Bigdeli-Wilshusen /ID# 272904

    Hanover, Lower Saxony, 30173, Germany

  • Private Practice - Dr. Daniel Bestler /ID# 251860

    Erfurt, 99096, Germany

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

    Hamburg, 22391, Germany

  • Private Practice - Dr. Sebastian Schuh /ID# 240498

    Coburg, 96450, Germany

  • Prof-med-stud.de /ID# 240458

    Munich, 80935, Germany

  • RHIO Forschungsinstitut /ID# 240525

    Meerbusch, 40668, Germany

  • Rheumahaus Studien GbR, Potsdam, DE /ID# 245231

    Potsdam, Brandenburg, 14467, Germany

  • Rheumapraxis Berlin /ID# 242987

    Berlin, 12435, Germany

  • Rheumapraxis Dr. Prothmann /ID# 240671

    Püttlingen, Saarland, 66346, Germany

  • Rheumapraxis Weimar /ID# 268387

    Weimar, Thuringia, 99427, Germany

  • Rheumapraxis am Webereck /ID# 240454

    Augsburg, 86157, Germany

  • Rheumathologie Ulm /ID# 240494

    Ulm, 89073, Germany

  • Rheumatologie Kassel /ID# 275998

    Kassel, Lower Saxony, 34125, Germany

  • Rheumatologische Facharztpraxis - Naumburg (Saale) /ID# 240477

    Naumburg, Saxony-Anhalt, 06618, Germany

  • Rheumatologische Praxis Dr. Jochen Walter /ID# 250263

    Rendsburg, Schleswig-Holstein, 24768, Germany

  • Rheumatologische Schwerpunktpraxis /ID# 245392

    Stuttgart, Baden-Wurttemberg, 70372, Germany

  • Rheumatologisches Medizinisches Versorgungszentrum Dresden /ID# 240516

    Dresden, Saxony, 01109, Germany

  • Rheumazentrum Ratingen /ID# 240465

    Ratingen, 40882, Germany

  • Rheumazentrum Ruhrgebiet /ID# 240460

    Herne, North Rhine-Westphalia, 44649, Germany

  • Stille, Hanover, DE /ID# 252222

    Hanover, Lower Saxony, 30161, Germany

  • Wernicke, Hohen Neuendorf, DE /ID# 250626

    Hohen Neuendorf, 16540, Germany

  • Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370

    Hanover, 30159, Germany

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Other studies related to the condition(s) this trial covers.