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Axial Spondylarthritis (r-axSpA)UpSPINENCT05094128

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

An observational study of Axial Spondylarthritis (r-axSpA), run by AbbVie at 72 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Axial Spondylarthritis (r-axSpA)
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
How many people
338 participants
Where
72 sitesGermany
Study dates
22 Nov 2021to Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

Germany72 sites

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

    Altenburg, Thuringia, 04600

  • Marycz, Amberg, DE /ID# 240483

    Amberg, 92224

  • Rheumapraxis am Webereck /ID# 240454

    Augsburg, 86157

  • Praxis S. Bresgulewski /ID# 240662

    Bad Bertrich, 56864

  • Kerckhoff Klinik /ID# 252219

    Bad Nauheim, 61231

  • ACURA Rheumazentrum Baden-Bade /ID# 249751

    Baden-Baden, Baden-Wurttemberg, 76530

  • Rheumapraxis Berlin /ID# 242987

    Berlin, 12435

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

    Berlin, 12555

  • Praxis Dr. Silke Zinke /ID# 240526

    Berlin, 13055

  • Krankenhaus Waldfriede /ID# 268389

    Berlin, 14163

  • Eisterhues, Braunschweig, DE /ID# 239438

    Braunschweig, 38100

  • MVZ Herzogin Elisabeth Hospital /ID# 267983

    Braunschweig, 38114

  • Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358

    Bruchhausen-Vilsen, Lower Saxony, 27305

  • Dr. Walberer /ID# 249752

    Burglengenfeld, 93133

  • Medizinischen Versorgungszentrums Agilomed /ID# 240481

    Chemnitz, Saxony, 09130

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

    Coburg, 96450

  • Krankenhaus Porz am Rhein /ID# 243765

    Cologne, North Rhine-Westphalia, 51149

  • Dres. Karger/Baerlecken /ID# 240442

    Cologne, 50996

  • MVZ-Medizinisches Versorgungszentrum Daun GmbH /ID# 254839

    Daun, 54550

  • Kreiskrankenhaus Demmin /ID# 240451

    Demmin, 17109

  • Rheumatologisches Medizinisches Versorgungszentrum Dresden /ID# 240516

    Dresden, Saxony, 01109

  • Praxis Dilltal /ID# 240520

    Ehringshausen, 35630

  • MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448

    Erfurt, Thuringia, 99096

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

    Erfurt, 99096

  • Michael Mueller, Freiberg, DE /ID# 240489

    Freiberg, 09599

  • Praxis Dres. Sensse/Sensse /ID# 240517

    Gifhorn, 38518

  • Praxis Dr. Liebhaber /ID# 240480

    Halle, Saxony-Anhalt, 06128

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

    Hamburg, 22391

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

    Hamburg, 22523

  • Stille, Hanover, DE /ID# 252222

    Hanover, Lower Saxony, 30161

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

    Hanover, Lower Saxony, 30173

  • Medizinische Hochschule Hannover /ID# 262814

    Hanover, Lower Saxony, 30625

  • Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370

    Hanover, 30159

  • Heilig, Heidelberg, DE /ID# 240492

    Heidelberg, Baden-Wurttemberg, 69120

  • Rheumazentrum Ruhrgebiet /ID# 240460

    Herne, North Rhine-Westphalia, 44649

  • Wernicke, Hohen Neuendorf, DE /ID# 250626

    Hohen Neuendorf, 16540

  • Praxis Bernd Mueller /ID# 240488

    Homburg, Saarland, 66424

  • Praxis K. Pagel /ID# 240490

    Hoppegarten, Brandenburg, 15366

  • Kremers, Juelich, DE /ID# 243357

    Jülich, 52428

  • Beyer, Kaiserslautern, DE /ID# 240444

    Kaiserslautern, Rhineland-Palatinate, 67659

  • Rheumatologie Kassel /ID# 275998

    Kassel, Lower Saxony, 34125

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

    Leipzig, Saxony, 04109

  • Praxis internistische Rheumatologie /ID# 240515

    Leipzig, Saxony, 04129

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

    Ludwigshafen, 67069

  • Aurich and Sieburg, Magdeburg /ID# 240518

    Magdeburg, Saxony-Anhalt, 39104

  • Praxis Dr. Annekatrin Rossbach /ID# 240495

    Mansfeld / Großörner, 06343

  • Harmuth, Marktredwitz, DE /ID# 240455

    Marktredwitz, 95615

  • RHIO Forschungsinstitut /ID# 240525

    Meerbusch, 40668

  • Prof-med-stud.de /ID# 240458

    Munich, 80935

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

    Naumburg, Saxony-Anhalt, 06618

  • Praxis Dr. med Thilo Klopsch /ID# 240461

    Neubrandenburg, 17033

  • Praxis Hein & Gess /ID# 240456

    Nienburg, 31582

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

    Planegg, 82152

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

    Plauen, 08523

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

    Potsdam, Brandenburg, 14467

  • Praxis Dr. Sabine Reckert /ID# 245142

    Potsdam, Brandenburg, 14469

  • Rheumapraxis Dr. Prothmann /ID# 240671

    Püttlingen, Saarland, 66346

  • Rheumazentrum Ratingen /ID# 240465

    Ratingen, 40882

  • Rheumatologische Praxis Dr. Jochen Walter /ID# 250263

    Rendsburg, Schleswig-Holstein, 24768

  • Melzer, Seesen, DE /ID# 240484

    Seesen, 38723

  • Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523

    Straubing, 94315

  • Rheumatologische Schwerpunktpraxis /ID# 245392

    Stuttgart, Baden-Wurttemberg, 70372

  • Krankenhaus der Barmherzigen Brüder Trier /ID# 240524

    Trier, Rhineland-Palatinate, 54292

  • Praxis Dr. Haas /ID# 242982

    Tübingen, Baden-Wurttemberg, 72072

  • Praxis Dr. Rinaldi /ID# 242984

    Ulm, Baden-Wurttemberg, 89073

  • Rheumathologie Ulm /ID# 240494

    Ulm, 89073

  • Praxis F. Schattenberg /ID# 257646

    Waren, 17192

  • Rheumapraxis Weimar /ID# 268387

    Weimar, Thuringia, 99427

  • Krankenhaus St. Josef /ID# 249747

    Wuppertal, 42105

  • Praxis Barmen /ID# 240449

    Wuppertal, 42285

  • Praxis Barmen /ID# 277515

    Wuppertal, 42285

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

    Zwickau, 08060

Other trials in Germany

About this study

Official title: 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.

Read more

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.

Being tested
Upadacitinib
Keywords
Axial Spondylarthritis (axSpA), Upadacitinib, RINVOQ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called RINVOQ

    Tablet; Oral

Study groups in NCT05094128
Study groupRoleWhat they receive
Participants Receiving Upadacitinib.Not described
Receives: Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Up to Week 52

Secondary outcomes (16)

  1. 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).

    Measured: Up to Week 52

  2. 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.

    Measured: Up to Week 52

  3. 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.

    Measured: Up to Week 52

  4. 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.

    Measured: Up to Week 52

  5. 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.

    Measured: Up to Week 52

  6. 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.

    Measured: Week 4

  7. 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.

    Measured: Up to Week 52

  8. Percentage of Participants with Resolution of Dactylitis for Participants with Baseline Dactylitis

    Presence of dactylitis (Yes/No) will be assessed by the physician.

    Measured: Up to Week 52

  9. 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.

    Measured: Up to Week 52

  10. 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.

    Measured: Up to Week 52

  11. 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).

    Measured: Up to Week 52

  12. 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).

    Measured: Up to Week 52

  13. 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.

    Measured: Up to Week 52

  14. 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.

    Measured: Up to Week 52

  15. Percentage of Participants with Recurrence of Typical Extra-Musculoskeletal Manifestations (EMMs)

    Participants with recurrence of typical extra-musculoskeletal manifestations (EMMs.

    Measured: Up to Week 52

  16. Percentage of Participants with new onset of typical EMMs

    Participants with new onset of typical EMMs

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start22 Nov 2021
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05094128
Sponsor's protocol ID
P21-007
Acronym
UpSPINE
Status last verified
May 2026
First submitted
20 Oct 2021
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Axial Spondylarthritis (r-axSpA), run by AbbVie at 72 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05094128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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