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Axial Spondylarthritis (axSpA)UPSTANDNCT04846244

A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib

An observational study of Axial Spondylarthritis (axSpA), run by AbbVie at 160 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Axial Spondylarthritis (axSpA)
How many people
708 participants
Where
160 sitesin 16 countries
Study dates
30 Apr 2021to 24 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

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 Radiographic Axial Spondylarthritis (r-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 Axial Spondylarthritis (axSpA) according to the ASAS criteria.
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 at Baseline.
  • Total back pain score >= 4 at Baseline.
  • Inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to contraindication for NSAIDs as defined by the investigator.
  • Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.

Who cannot join

  • Prior exposure to any Janus kinase (JAK) inhibitor.
  • Participants demonstrating active symptoms of fibromyalgia as per clinical diagnosis.
  • Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
  • Unwillingness or inability to comply with the study requirements, including completion of patient reported outcome questionnaires.
  • Participants who cannot be treated with upadacitinib according to the applicable approved label (e.g., contraindications).
  • Vulnerable or protected adult patients with lack of capability to give informed consent.

Trial locations and contacts

160 sites in 16 countries.

160 sites in 16 countries

France32 sites

  • CH du Pays d'AIX /ID# 229095

    Aix-en-Provence, 13616

  • CHU Amiens-Picardie Site Sud /ID# 228821

    Amiens, Somme, 80054

  • Centre Hospitalier d'Arras /ID# 228833

    Arras, 62022

  • CHU de Besancon - Jean Minjoz /ID# 230528

    Besançon, Doubs, 25030

  • CHU de Besancon - Jean Minjoz /ID# 242499

    Besançon, Doubs, 25030

  • CHU Bordeaux - Hopital Pellegrin /ID# 230548

    Bordeaux, Gironde, 33076

  • Infirmerie Protestante /ID# 228794

    Caluire-et-Cuire, Rhone, 69300

  • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 229092

    Clermont-Ferrand, 63000

  • C. H. Sud Francilien /ID# 228826

    Corbeil-Essonnes, 91106

  • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947

    La Roche-sur-Yon, 85000

  • CHU Grenoble - Hopital Michallon /ID# 228792

    La Tronche, 38700

  • CHU Lille - Hôpital Roger Salengro /ID# 228820

    Lille, 59037

  • CHU Limoges - Dupuytren 1 /ID# 229094

    Limoges, Franche-Comte, 87042

  • Clinique de la Sauvegarde /ID# 229087

    Lyon, 69009

  • Cabinet de rhumatologie /ID# 229091

    Mennecy, Essonne, 91540

  • CHU Montpellier - Hôpital Saint Eloi /ID# 228829

    Montpellier, Herault, 34295

  • CHU Montpellier - Hôpital Saint Eloi /ID# 240980

    Montpellier, Herault, 34295

  • CHU Nice -Hopital Pasteur /ID# 229088

    Nice, Provence-Alpes-Côte d'Azur Region, 06002

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 234258

    Orléans, 45067

  • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 244006

    Paris, Paris, 75679

  • AP-HP - Hopital Saint-Antoine /ID# 228795

    Paris, 75012

  • Hopital Pitie Salpetriere /ID# 243309

    Paris, 75013

  • Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737

    Paris, 75015

  • AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837

    Paris, 75018

  • GH Diaconesses Croix Saint-Simon /ID# 238548

    Paris, 75020

  • HCL - Hopital Lyon Sud /ID# 228819

    Pierre-Bénite, Rhone, 69495

  • Polyclinique Courlancy /ID# 229093

    Reims, Marne, 51100

  • CHU de Rennes - Hospital Sud /ID# 228842

    Rennes, 35203

  • Hôpital Charles-Nicolle /ID# 229096

    Rouen, 76000

  • CHU de SAINT ETIENNE - Hopital Nord /ID# 228836

    Saint Priest EN Jarez, Pays de la Loire Region, 42270

  • CH Saint Nazaire /ID# 233186

    Saint-Nazaire, 44600

  • CHU Toulouse - Hopital Purpan /ID# 228818

    Toulouse, Haute-Garonne, 31059

Other trials in France

Spain23 sites

  • Hospital Universitario Torrecardenas /ID# 252804

    Almería, 04009

  • Complejos Hospitalario Universitario de Badajoz /ID# 249036

    Badajoz, 06010

  • Hospital Universitario Germans Trias i Pujol /ID# 249030

    Badalona, Barcelona, 08916

  • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042

    El Palmar, Murcia, 30120

  • Hospital Campus de la Salud /ID# 252805

    Granada, 18016

  • Hospital Juan Ramon Jimenez /ID# 249040

    Huelva, 21005

  • Hospital Universitario de Jaen /ID# 249041

    Jaén, 23007

  • Hospital San Pedro /ID# 249028

    Logroño, La Rioja, 26006

  • Hospital Universitario Lucus Augusti /ID# 255820

    Lugo, 27003

  • Hospital Universitario Ramon y Cajal /ID# 249035

    Madrid, 28034

  • Hospital Universitario 12 de Octubre /ID# 249033

    Madrid, 28041

  • Hospital de Mérida /ID# 249037

    Mérida, Badajoz, 06800

  • Hospital Río Carrión /ID# 249027

    Palencia, 34005

  • Hospital Universitario Son Llàtzer /ID# 249032

    Palma de Mallorca, Las Palmas, 07198

  • Hospital Universitario Canarias /ID# 249043

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Hospital Infanta Sofia /ID# 249034

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Universitario Nuestra Señora de Candelaria /ID# 249044

    Santa Cruz de Tenerife, 38010

  • Complejo Hospitalario Universitario de Santiago /ID# 249025

    Santiago de Compostela, A Coruna, 15076

  • Hospital Universitario Virgen Macarena /ID# 249039

    Seville, 41009

  • Hospital Universitario Virgen del Rocio /ID# 249038

    Seville, 41013

  • Hospital Universitario Mutua Terrassa /ID# 249031

    Terrassa, Barcelona, 08221

  • Hospital Clinico Universitario de Valladolid /ID# 252001

    Valladolid, 47003

  • Hospital Virgen de la Concha /ID# 249026

    Zamora, 49022

Other trials in Spain

Russia19 sites

  • Chelyabinsk Regional Clinical Hospital /ID# 244741

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Regional Clinical Hospital of Kaliningrad region /ID# 238475

    Kaliningrad, Kaliningrad Oblast, 236016

  • Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479

    Moscow, Moscow, 115522

  • Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510

    Moscow, Moscow Oblast, 129110

  • City Clinical Hospital #52 /ID# 238477

    Moscow, 123182

  • Orenburg State Medical University /ID# 233183

    Orenburg, 460000

  • Republican hospital named after V.A. Baranov /ID# 231173

    Petrozavodsk, 185019

  • Nort-Western State Medical University n.a. Mechnikov /ID# 231172

    Saint Petersburg, Sankt-Peterburg, 193015

  • Clinical Rheumatologic Hospital No 25 /ID# 231171

    Saint Petersburg, 190068

  • Military Medical Academy n.a. Kirov /ID# 242363

    Saint Petersburg, 194044

  • Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169

    Samara, Samara Oblast, 443095

  • Clinic of Samara State Medical University /ID# 241166

    Samara, 443079

  • GBUZ RM Mordovia Republican Central Clinical Hospital /ID# 244738

    Saransk, Mordoviya, Respublika, 430901

  • Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra Surgut Dist /ID# 242369

    Surgut, 628400

  • LLC MC RevmaMed /ID# 238478

    Syktyvkar, Komi, 167031

  • Nebbiolo Clinical Research Center /ID# 231167

    Tomsk, 634009

  • ChUZ Clinical Hospital RZD-Medicine /ID# 233185

    Ulan-Ude, Buryatiya, Respublika, 670002

  • Ulyanovsk Regional Clinical Hospital /ID# 238334

    Ulyanovsk, 432017

  • Yaroslavl State Medicat University /ID# 231168

    Yaroslavl, 150000

Other trials in Russia

Canada15 sites

  • Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213

    Dundas, Ontario, L9H 1B7

  • Arthur Karasik Medicine Professional Corporation /ID# 241932

    Etobicoke, Ontario, M9C 5N2

  • Lau Bacchus Professional Medicine Corp /ID# 242591

    Hamilton, Ontario, L8N 1Y2

  • Credit Valley Rheumatology /ID# 241948

    Mississauga, Ontario, L5M 2V8

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765

    Montreal, Quebec, H1T 2M4

  • Applied Medical Informatics Research Inc. (AMIR) /ID# 246284

    Montreal, Quebec, H4A 3T2

  • The Waterside Clinic /ID# 248678

    Orillia, Ontario, L3V 1T5

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 241111

    Sainte-Foy, Quebec, G1V 3M7

  • Dr Naik-Medical Professional Corporation-Alliance Health /ID# 246516

    Saskatoon, Saskatchewan, S7H 5M7

  • CIUSSS de l'Estrie - CHUS /ID# 247572

    Sherbrooke, Quebec, J1G 2E8

  • Dr. Juris Lazovskis Inc. /ID# 246574

    Sydney, Nova Scotia, B1S 3N1

  • Artus Health Center /ID# 241966

    Vancouver, British Columbia, V5Z 1J9

  • Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933

    Windsor, Ontario, N8X 1T3

  • Manitoba Clinic /ID# 246217

    Winnipeg, Manitoba, R3A 1M3

  • CIADS Research Co Ltd /ID# 247520

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Greece14 sites

  • Vougiouklakeio S.A. /ID# 246476

    Aigáleo, 12242

  • General Hospital of Athens Ippokratio /ID# 241133

    Athens, Attica, 11527

  • General Hospital of Athens Laiko /ID# 241128

    Athens, Attica, 11527

  • Naval Hospital of Athens /ID# 241129

    Athens, 11521

  • KAT Atttica General Hospital /ID# 243063

    Athens, 14561

  • 424 General MILITARY Hospital /ID# 241127

    Efkarpia (Thessalonikis), Thessaloniki, 56429

  • University General Hospital of Heraklion PA.G.N.I /ID# 241124

    Heraklion, Crete, 71500

  • Duplicate_General Hospital of Thessaloniki Agios Pavlos /ID# 243823

    Kalamaria, 55134

  • Iaso /ID# 245137

    Marousi, 15123

  • Olympion General Clinic SA /ID# 251794

    Pátrai, 26443

  • University General Hospital of Patras /ID# 243795

    RION Patras Achaia, 26504

  • Euromedica Blue Cross Gen Clin /ID# 244945

    Thessaloniki, 54636

  • General Hospital of Thessaloniki Hippokrateio /ID# 243796

    Thessaloniki, 54642

  • Euromedica General Clinic /ID# 241126

    Thessaloniki, 54645

Other trials in Greece

Belgium10 sites

  • Onze Lieve Vrouw Hospital /ID# 238963

    Aalst, 9300

  • Université Libre de Bruxelles - Hôpital Erasme /ID# 238961

    Anderlecht, Brussels Capital, 1070

  • AZ Sint-Jan Brugge /ID# 238964

    Bruges, 8000

  • CHU Brugmann /ID# 238962

    Brussels, 1020

  • Rhumaconsult SPRL /ID# 231439

    Charleroi, Hainaut, 6000

  • Reumacentrum /ID# 231437

    Genk, 3600

  • ReumaClinic /ID# 231438

    Genk, 3600

  • CHU de Liège /ID# 231440

    Liège, Liege, 4000

  • AZ Damiaan /ID# 231441

    Ostend, 8400

  • AZ-Delta /ID# 238966

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Australia8 sites

  • Genesis Research Services /ID# 231593

    Broadmeadow, New South Wales, 2292

  • Campbelltown Hospital /ID# 231462

    Campbelltown, New South Wales, 2560

  • Royal Prince Alfred Hospital /ID# 232417

    Camperdown, New South Wales, 2050

  • Barwon Rheumatology Services /ID# 230068

    Geelong, Victoria, 3220

  • Peninsula Rheumatology /ID# 240172

    Langwarrin, Victoria, 3910

  • Joint West Rheumatology /ID# 231461

    Murdoch, Western Australia, 6150

  • BJC Health /ID# 230066

    Parramatta, New South Wales, 2150

  • Paratus Clinical Research Woden /ID# 231460

    Phillip, Australian Capital Territory, 2606

Other trials in Australia

Israel8 sites

  • Hillel Yaffe Medical Center /ID# 241869

    Hadera, H_efa, 38100

  • Bnai Zion Medical Center /ID# 241866

    Haifa, H_efa, 3339419

  • The Lady Davis Carmel Medical Center /ID# 241867

    Haifa, H_efa, 34362

  • Meir Medical Center /ID# 241868

    Kfar Saba, Central District, 4428164

  • Galilee Medical Center /ID# 241870

    Nahariya, Northern District, 2210001

  • The Chaim Sheba Medical Center /ID# 241305

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 241864

    Tel Aviv, Tel Aviv, 6423906

  • The Baruch Padeh Medical Center Poriya /ID# 249797

    Tiberias, Northern District, 15208

Other trials in Israel

Argentina5 sites

  • Hospital Italiano La Plata /ID# 230779

    La Plata, Buenos Aires, 1902

  • CER Instituto Medico /ID# 230782

    Quilmes, Buenos Aires, 1878

  • Clinica Regional del Sud /ID# 248866

    Río Cuarto, 5800

  • Instituto CAICI S.R.L /ID# 230781

    Rosario, Santa Fe Province, 2000

  • Duplicate_CIMER /ID# 230780

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Bulgaria5 sites

  • Prof. Anastas Batalov AIPSMP-VBR EOOD /ID# 249788

    Plovdiv, 4000

  • Medical center Unimed /ID# 249618

    Plovdiv, 4023

  • "Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791

    Sofia, 1000

  • ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789

    Sofia, 1750

  • AIPSMPR -d-r Gerganov /ID# 249749

    Varna, 9002

Other trials in Bulgaria

Hungary5 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939

    Budapest, 1134

  • Debreceni Egyetem Klinikai Kozpont /ID# 239936

    Debrecen, Hajdú-Bihar, 4032

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937

    Debrecen, 4031

  • Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940

    Hévíz, 8380

  • Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938

    Kecskemét, 6000

Other trials in Hungary

Kuwait5 sites

  • Adan Hospital /ID# 229679

    ADAN

  • Jahra Hospital /ID# 229671

    Al Jahra, 52700

  • Mubarak Hospital /ID# 250478

    Hawalli, 46300

  • Mubarak Hospital /ID# 251777

    Hawalli, 46300

  • Farwaniya Hospital /ID# 231445

    Kuwait City, 85000

Other trials in Kuwait

Poland4 sites

  • Ma?opolskie Badania Kliniczne Sp. z o.o. /ID# 255509

    Cracow, 30-040

  • Jerzy ?wierkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289

    Oława, 55-200

  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225

    Poznan, Greater Poland Voivodeship, 61-545

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232

    Warsaw, Masovian Voivodeship, 02-637

Other trials in Poland

Switzerland3 sites

  • Studio Zanisi /ID# 255681

    Locarno, Canton Ticino, 6600

  • Kantonsspital St. Gallen /ID# 230696

    Sankt Gallen, Canton of St. Gallen, 9007

  • Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435

    Weinfelden, Thurgau, 8570

Other trials in Switzerland

Mexico2 sites

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815

    Guadalajara, Jalisco, 44650

  • Private Office Dr. Orozco /ID# 255210

    Guadalajara, Jalisco, 44650

Other trials in Mexico

United Arab Emirates2 sites

  • Cleveland Clinic Abu Dhabi /ID# 256292

    Abu Dhabi

  • AlAin Hospital /ID# 233803

    Dubai

Other trials in United Arab Emirates

About this study

Official title: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Axial Spondylarthritis (UPSTAND)

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 (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens 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 pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants.

Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.

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. Participants will be followed for 12 months.

There may be a higher burden for participants in this study compared to usual standard of care. 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.

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.

Study groups in NCT04846244
Study groupRoleWhat they receive
Participants Receiving UpadacitinibParticipants receiving Upadacitinib for axial spondyloarthritis (axSpA).

What is being measured

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

  1. Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement

    Total spinal pain consists of the mean of two 0-10 numerical rating scale (NRS) questions: total back pain during the previous week and nocturnal back pain during the previous week.

    Measured: Baseline (Week 0) to Week 12

  2. Percentage of Participants Maintaining Total Spinal Pain < 4 Among Participants Who Achieved Total Spinal Pain < 4 and >= 2 unit (0 - 10) Improvement from Baseline at Week 12

    Total spinal pain score consists of the mean of two 0-10 NRS questions: total back pain during the previous week and nocturnal back pain during the previous week.

    Measured: 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 posted15 Apr 2021
  2. Study start30 Apr 2021
  3. Primary completion24 Mar 2025
  4. Study completion24 Mar 2025

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
708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04846244
Sponsor's protocol ID
P20-410
Acronym
UPSTAND
Status last verified
Mar 2026
First submitted
13 Apr 2021
Last updated
25 Mar 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 (axSpA), run by AbbVie at 160 sites in 16 countries.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in France, Spain, Russia, Canada, Greece and 11 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement (time frame: Baseline (Week 0) to Week 12). 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 NCT04846244.

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 25 Mar 2026.

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