A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib
- Conditions
- Axial Spondylarthritis (axSpA)
- Registration Number
- NCT04846244
- Lead Sponsor
- AbbVie
- 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 (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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 708
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with a Total Spinal Pain Score < 4 and >= 2 Unit (0 - 10) Improvement Baseline (Week 0) to Week 12 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.
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 Week 52 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (160)
University General Hospital of Patras /ID# 243795
🇬🇷RION Patras Achaia, Greece
ReumaClinic /ID# 231438
🇧🇪Genk, Belgium
Hospital Italiano La Plata /ID# 230779
🇦🇷La Plata, Buenos Aires, Argentina
Clinica Regional del Sud /ID# 248866
🇦🇷Rio Cuarto, Argentina
General Hospital of Athens Ippokratio /ID# 241133
🇬🇷Athens, Attiki, Greece
424 General MILITARY Hospital /ID# 241127
🇬🇷Efkarpia (Thessalonikis), Thessaloniki, Greece
CHU de Besancon - Jean Minjoz /ID# 230528
🇫🇷Besancon, Doubs, France
CHU Bordeaux - Hopital Pellegrin /ID# 230548
🇫🇷Bordeaux CEDEX, Gironde, France
Iaso /ID# 245137
🇬🇷Maroussi, Greece
CHU Lille - Hôpital Roger Salengro /ID# 228820
🇫🇷Lille, France
Groupe de Recherche en Maladies Osseuses Inc /ID# 241111
🇨🇦Sainte-foy, Quebec, Canada
AP-HP - Hopital Saint-Antoine /ID# 228795
🇫🇷Paris, France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837
🇫🇷Paris, France
CHU de Besancon - Jean Minjoz /ID# 242499
🇫🇷Besancon, Doubs, France
Reumacentrum /ID# 231437
🇧🇪Genk, Belgium
Paratus Clinical Research Woden /ID# 231460
🇦🇺Phillip, Australian Capital Territory, Australia
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 249765
🇨🇦Montreal, Quebec, Canada
Infirmerie Protestante /ID# 228794
🇫🇷Caluire Et Cuire, Rhone, France
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 229092
🇫🇷Clermont Ferrand, France
CHU Limoges - Dupuytren 1 /ID# 229094
🇫🇷Limoges CEDEX 1, Franche-Comte, France
Euromedica General Clinic /ID# 241126
🇬🇷Thessaloniki, Greece
CIUSSS de l'Estrie - CHUS /ID# 247572
🇨🇦Sherbrooke, Quebec, Canada
Vougiouklakeio S.A. /ID# 246476
🇬🇷Egaleo, Greece
Applied Medical Informatics Research Inc. (AMIR) /ID# 246284
🇨🇦Montréal, Quebec, Canada
CHU Nice -Hopital Pasteur /ID# 229088
🇫🇷Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France
CHU Montpellier - Hôpital Saint Eloi /ID# 240980
🇫🇷Montpellier Cedex 5, Herault, France
Medical center Unimed /ID# 249618
🇧🇬Plovdiv, Bulgaria
CH du Pays d'AIX /ID# 229095
🇫🇷Aix En Provence Cedex 1, France
Euromedica Blue Cross Gen Clin /ID# 244945
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 243796
🇬🇷Thessaloniki, Greece
Hillel Yaffe Medical Center /ID# 241869
🇮🇱Hadera, H_efa, Israel
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 244006
🇫🇷Paris CEDEX 14, Paris, France
The Chaim Sheba Medical Center /ID# 241305
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 241864
🇮🇱Tel Aviv, Tel-Aviv, Israel
CHU Montpellier - Hôpital Saint Eloi /ID# 228829
🇫🇷Montpellier Cedex 5, Herault, France
Centre Hospitalier d'Arras /ID# 228833
🇫🇷Arras, France
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232
🇵🇱Warsaw, Mazowieckie, Poland
Naval Hospital of Athens /ID# 241129
🇬🇷Athens, Greece
Bnai Zion Medical Center /ID# 241866
🇮🇱Haifa, H_efa, Israel
Hospital Universitario Germans Trias i Pujol /ID# 249030
🇪🇸Badalona, Barcelona, Spain
Hospital Campus de la Salud /ID# 252805
🇪🇸Granada, Spain
HCL - Hopital Lyon Sud /ID# 228819
🇫🇷Pierre Benite CEDEX, Rhone, France
Clinique de la Sauvegarde /ID# 229087
🇫🇷Lyon, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 234258
🇫🇷Orléans, France
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938
🇭🇺Kecskemet, Hungary
Hospital Universitario 12 de Octubre /ID# 249033
🇪🇸Madrid, Spain
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939
🇭🇺Budapest, Hungary
General Hospital of Athens Laiko /ID# 241128
🇬🇷Athens, Attiki, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 241124
🇬🇷Heraklion, Kriti, Greece
KAT Atttica General Hospital /ID# 243063
🇬🇷Athens, Greece
The Lady Davis Carmel Medical Center /ID# 241867
🇮🇱Haifa, H_efa, Israel
Meir Medical Center /ID# 241868
🇮🇱Kfar Saba, HaMerkaz, Israel
Nort-Western State Medical University n.a. Mechnikov /ID# 231172
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Clinical Rheumatologic Hospital No 25 /ID# 231171
🇷🇺St. Petersburg, Russian Federation
Regional Clinical Hospital of Kaliningrad region /ID# 238475
🇷🇺Kaliningrad, Kaliningradskaya Oblast, Russian Federation
GBUZ RM Mordovia Republican Central Clinical Hospital /ID# 244738
🇷🇺Saransk, Mordoviya, Respublika, Russian Federation
Galilee Medical Center /ID# 241870
🇮🇱Nahariya, HaTsafon, Israel
Hôpital Charles-Nicolle /ID# 229096
🇫🇷Rouen, France
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947
🇫🇷La Roche Sur Yon, France
CHU Grenoble - Hopital Michallon /ID# 228792
🇫🇷La Tronche, France
Debreceni Egyetem Klinikai Kozpont /ID# 239936
🇭🇺Debrecen, Hajdu-Bihar, Hungary
The Baruch Padeh Medical Center Poriya /ID# 249797
🇮🇱Tiberias, HaTsafon, Israel
Mubarak Hospital /ID# 250478
🇰🇼Hawalli, Kuwait
Ma?opolskie Badania Kliniczne Sp. z o.o. /ID# 255509
🇵🇱Cracow, Poland
Jerzy ?wierkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289
🇵🇱Oława, Poland
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937
🇭🇺Debrecen, Hungary
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510
🇷🇺Moscow, Moskovskaya Oblast, Russian Federation
Military Medical Academy n.a. Kirov /ID# 242363
🇷🇺St. Petersburg, Russian Federation
Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra Surgut Dist /ID# 242369
🇷🇺Surgut, Russian Federation
Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940
🇭🇺Heviz, Hungary
Chelyabinsk Regional Clinical Hospital /ID# 244741
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Complejo Hospitalario Universitario de Santiago /ID# 249025
🇪🇸Santiago de Compostela, A Coruna, Spain
Clinic of Samara State Medical University /ID# 241166
🇷🇺Samara, Russian Federation
Jahra Hospital /ID# 229671
🇰🇼Jahra, Kuwait
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225
🇵🇱Poznan, Wielkopolskie, Poland
Hospital de Mérida /ID# 249037
🇪🇸Mérida, Badajoz, Spain
Hospital Universitario Lucus Augusti /ID# 255820
🇪🇸Lugo, Spain
Hospital Universitario Torrecardenas /ID# 252804
🇪🇸Almeria, Spain
Hospital Universitario Ramon y Cajal /ID# 249035
🇪🇸Madrid, Spain
Nebbiolo Clinical Research Center /ID# 231167
🇷🇺Tomsk, Russian Federation
Republican hospital named after V.A. Baranov /ID# 231173
🇷🇺Petrozavodsk, Russian Federation
Complejos Hospitalario Universitario de Badajoz /ID# 249036
🇪🇸Badajoz, Spain
Hospital Río Carrión /ID# 249027
🇪🇸Palencia, Spain
Studio Zanisi /ID# 255681
🇨🇭Locarno, Ticino, Switzerland
Hospital Clinico Universitario de Valladolid /ID# 252001
🇪🇸Valladolid, Spain
Hospital Virgen de la Concha /ID# 249026
🇪🇸Zamora, Spain
Hospital Universitario Mutua Terrassa /ID# 249031
🇪🇸Terrasa, Barcelona, Spain
ChUZ Clinical Hospital RZD-Medicine /ID# 233185
🇷🇺Ulan-Ude, Buryatiya, Respublika, Russian Federation
Hospital Universitario Canarias /ID# 249043
🇪🇸San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Juan Ramon Jimenez /ID# 249040
🇪🇸Huelva, Spain
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 249042
🇪🇸El Palmar, Murcia, Spain
Kantonsspital St. Gallen /ID# 230696
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Hospital Universitario Virgen del Rocio /ID# 249038
🇪🇸Sevilla, Spain
Hospital Universitario de Jaen /ID# 249041
🇪🇸Jaen, Spain
CER Instituto Medico /ID# 230782
🇦🇷Quilmes, Buenos Aires, Argentina
Duplicate_CIMER /ID# 230780
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Genesis Research Services /ID# 231593
🇦🇺Broadmeadow, New South Wales, Australia
Campbelltown Hospital /ID# 231462
🇦🇺Campbelltown, New South Wales, Australia
Royal Prince Alfred Hospital /ID# 232417
🇦🇺Camperdown, New South Wales, Australia
BJC Health /ID# 230066
🇦🇺Paramatta, New South Wales, Australia
Barwon Rheumatology Services /ID# 230068
🇦🇺Geelong, Victoria, Australia
Duplicate_General Hospital of Thessaloniki Agios Pavlos /ID# 243823
🇬🇷Kalamaria, Greece
Olympion General Clinic SA /ID# 251794
🇬🇷Patras, Greece
Peninsula Rheumatology /ID# 240172
🇦🇺Langwarrin, Victoria, Australia
Université Libre de Bruxelles - Hôpital Erasme /ID# 238961
🇧🇪Anderlecht, Bruxelles-Capitale, Belgium
Joint West Rheumatology /ID# 231461
🇦🇺Murdoch, Western Australia, Australia
Rhumaconsult SPRL /ID# 231439
🇧🇪Charleroi, Hainaut, Belgium
CHU de Liège /ID# 231440
🇧🇪Liège, Liege, Belgium
AZ-Delta /ID# 238966
🇧🇪Roeselare, West-Vlaanderen, Belgium
Onze Lieve Vrouw Hospital /ID# 238963
🇧🇪Aalst, Belgium
CHU Brugmann /ID# 238962
🇧🇪Bruxelles, Belgium
AZ Damiaan /ID# 231441
🇧🇪Oostende, Belgium
Prof. Anastas Batalov AIPSMP-VBR EOOD /ID# 249788
🇧🇬Plovdiv, Bulgaria
"Ambulatory for individual practice of specialized medical help for internal dis /ID# 249791
🇧🇬Sofiya, Bulgaria
ASIMP Rheumatology Centre "St. Irina" EOOD /ID# 249789
🇧🇬Sofiya, Bulgaria
Artus Health Center /ID# 241966
🇨🇦Vancouver, British Columbia, Canada
AIPSMPR -d-r Gerganov /ID# 249749
🇧🇬Varna, Bulgaria
Manitoba Clinic /ID# 246217
🇨🇦Winnipeg, Manitoba, Canada
CIADS Research Co Ltd /ID# 247520
🇨🇦Winnipeg, Manitoba, Canada
Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213
🇨🇦Dundas, Ontario, Canada
Dr. Juris Lazovskis Inc. /ID# 246574
🇨🇦Sydney, Nova Scotia, Canada
Arthur Karasik Medicine Professional Corporation /ID# 241932
🇨🇦Etobicoke, Ontario, Canada
Lau Bacchus Professional Medicine Corp /ID# 242591
🇨🇦Hamilton, Ontario, Canada
Credit Valley Rheumatology /ID# 241948
🇨🇦Mississauga, Ontario, Canada
The Waterside Clinic /ID# 248678
🇨🇦Orillia, Ontario, Canada
AZ Sint-Jan Brugge /ID# 238964
🇧🇪Brugge, Belgium
C. H. Sud Francilien /ID# 228826
🇫🇷Corbeil Essonnes, France
Hopital Pitie Salpetriere /ID# 243309
🇫🇷Paris, France
CH Saint Nazaire /ID# 233186
🇫🇷St Nazaire, France
CHU de Rennes - Hospital Sud /ID# 228842
🇫🇷Rennes CEDEX 2, France
LLC MC RevmaMed /ID# 238478
🇷🇺Syktyvkar, Komi, Respublika, Russian Federation
Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479
🇷🇺Moscow, Moskva, Russian Federation
City Clinical Hospital #52 /ID# 238477
🇷🇺Moscow, Russian Federation
Orenburg State Medical University /ID# 233183
🇷🇺Orenburg, Russian Federation
Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169
🇷🇺Samara, Samarskaya Oblast, Russian Federation
Ulyanovsk Regional Clinical Hospital /ID# 238334
🇷🇺Ulyanovsk, Russian Federation
Hospital Universitario Nuestra Señora de Candelaria /ID# 249044
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Macarena /ID# 249039
🇪🇸Sevilla, Spain
Yaroslavl State Medicat University /ID# 231168
🇷🇺Yaroslavl, Russian Federation
Hospital San Pedro /ID# 249028
🇪🇸Logroño, La Rioja, Spain
CHU de SAINT ETIENNE - Hopital Nord /ID# 228836
🇫🇷St. Priest En Jarez, Loire, France
CHU Amiens-Picardie Site Sud /ID# 228821
🇫🇷Amiens CEDEX 1, Somme, France
AlAin Hospital /ID# 233803
🇦🇪Dubai, United Arab Emirates
Adan Hospital /ID# 229679
🇰🇼Adan, Kuwait
Cleveland Clinic Abu Dhabi /ID# 256292
🇦🇪Abu Dhabi, United Arab Emirates
Private Office Dr. Orozco /ID# 255210
🇲🇽Guadalajara, Jalisco, Mexico
Cabinet de rhumatologie /ID# 229091
🇫🇷Mennecy, Essonne, France
CHU Toulouse - Hopital Purpan /ID# 228818
🇫🇷TOULOUSE Cedex 9, Haute-Garonne, France
Polyclinique Courlancy /ID# 229093
🇫🇷Reims, Marne, France
Farwaniya Hospital /ID# 231445
🇰🇼Kuwait City, Kuwait
Mubarak Hospital /ID# 251777
🇰🇼Hawalli, Kuwait
Hospital Universitario Son Llàtzer /ID# 249032
🇪🇸Palma de Mallorca, Las Palmas, Spain
Instituto CAICI S.R.L /ID# 230781
🇦🇷Rosario, Santa Fe, Argentina
Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435
🇨🇭Weinfelden, Thurgau, Switzerland
Dr Naik-Medical Professional Corporation-Alliance Health /ID# 246516
🇨🇦Saskatoon, Saskatchewan, Canada
Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933
🇨🇦Windsor, Ontario, Canada
Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737
🇫🇷Paris, France
GH Diaconesses Croix Saint-Simon /ID# 238548
🇫🇷Paris, France
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Infanta Sofia /ID# 249034
🇪🇸San Sebastián de Los Reyes, Madrid, Spain