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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04846244
Collaborator
(none)
877
141
47
6.2
0.1

Study Details

Study Description

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. Despite this, there is a lack of detailed data and knowledge on pain in radiographic-axial spondyloarthritis (r-axSpA), including pain types, how it is localized, and how these different facets of pain are impacted by treatment. 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 radiographic axSpA participants.

Upadacitinib is being developed for the treatment of r-axSpA. Approximately 877 adult participants with activer-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. The overall duration of the study is approximately 30 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    877 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Radiographic Axial Spondylarthritis (UPSTAND)
    Actual Study Start Date :
    Apr 30, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Participants Receiving Upadacitinib

    Participants receiving Upadacitinib for radiographic axial spondyloarthritis (r-axSpA).

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    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 [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

    1. Change in Participant's Assessment of Total Spinal Pain [Baseline to Week 52]

      Total spinal pain 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.

    2. Change in Patient's Assessment of Total Back Pain NRS [Baseline (Week 0) to Week 52]

      Pain will be measured using a 0 - 10 numerical rating scale (NRS) for total back pain (0 = no pain and 10 = most severe pain).

    3. Change in Patient's Assessment of Nocturnal Back Pain NRS [Baseline (Week 0) to Week 52]

      Pain will be measured using a 0 - 10 numerical rating scale (NRS) for nocturnal back pain (0 = no pain and 10 = most severe pain).

    4. Change in painDETECT Questionnaire (PD-Q) Score [Baseline (Week 0) to Week 52]

      The PD-Q is a patient-based questionnaire used to determine the prevalence of neuropathic pain components in low back pain participants. Scores range from -1 to 38, with higher scores indicating a greater likelihood of the participant's pain having a neuropathic component.

    5. Change in Widespread Pain Index (WPI) [Baseline (Week 0) to Week 52]

      The WPI quantifies the extent of bodily pain on a 0 to 19 scale by asking participants if they have had pain or tenderness in 19 different body regions (shoulder girdle, hip, jaw, upper arm, upper leg, lower arm, and lower leg on each side of the body, as well as upper back, lower back, chest, neck, and abdomen) over the past week, with each painful or tender region scoring 1 point.

    6. Percentage of Participants Achieving Pittsburgh Sleep Quality Index (PSQI) score < 5 [Up to Week 52]

      The PSQI consists of 19 individual items across 7 components: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component is scored from 0 (no difficulty) to 3 (severe difficulty) and summed to produce a total global score (range 0 to 21). A score of less than 5 is indicative of no clinical sleep impairment

    7. Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity .[ASDAS LDA (< 2.1)] [Up to Week 52]

      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.

    8. Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Inactive Disease [ASDAS ID (<1.3)] [Up to Week 52]

      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.

    9. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Baseline (Week 0) to Week 52]

      The BASDAI consists of 6 questions on a 0 to 10 NRS (0 being no problem and 10 being very severe problems) pertaining to the 5 major symptoms of r-axSpA: fatigue, spinal pain, peripheral joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.

    10. Change in 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) [Baseline (Week 0) to Week 52]

      The SF-12 is a generic health-related QoL instrument consisting of a subset of 12 questions from the 36-Item Short Form Health Survey (SF-36). It assesses quality of life (QoL) across 8 domains: physical functioning, role physical, role emotional, social functioning, bodily pain, vitality, mental health, and general health. The SF-12 is used to derive the PCS with higher scores indicating a higher QoL.

    11. Change in 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS) [Baseline (Week 0) to Week 52]

      The SF-12 is a generic health-related QoL instrument consisting of a subset of 12 questions from the 36-Item Short Form Health Survey (SF-36). It assesses quality of life (QoL) across 8 domains: physical functioning, role physical, role emotional, social functioning, bodily pain, vitality, mental health, and general health. The SF-12 is used to derive the MCS with higher scores indicating a higher QoL.

    12. Percentage of Participants Achieving [Hospital Anxiety and Depression Scale (HADS) score <= 7] for a participants with HADS score > 7 at Baseline [Up to Week 52]

      The HADS assesses participant mental health status (consists of anxiety [Hospital Anxiety and Depression Scale-Anxiety (HADS-A)] and depression [Hospital Anxiety and Depression Scale-Depression (HADS-D)] subscales). The range for both subscales is 0 - 21, with 0 - 7 = normal, 8 - 10 = borderline abnormal, and 11 - 21 = abnormal.

    13. Change in Bath Ankylosing Spondylitis Functional Index (BASFI) [Baseline (Week 0) to Week 52]

      The BASFI is a validated patient-reported outcome (PRO) instrument for use in the r-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 r-axSpA patients 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 r-axSpA participants.

    14. Change in ASDAS [Baseline (Week 0) to Week 52]

      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).

    15. Change in C-Reactive Protein (CRP) [Baseline (Week 0) to Week 52]

      Change in CRP.

    16. Percentage of Participants with Discontinuation of Nonsteroidal Anti-Inflammatory Drug (NSAID) Among Participants using NSAIDs at Baseline [Up to Week 52]

      Discontinuation of NSAID among participants using NSAIDs at Baseline.

    17. Percentage of Participants using NSAIDs as Needed or Continuously [Baseline (Week 0) to Week 52]

      Percentage of participants using NSAIDs as needed or continuously.

    18. Change in Total Daily Dose of NSAIDs [Baseline (Week 0) to Week 52]

      Change in total daily dose of NSAIDs.

    19. Percentage of Participants Achieving Enthesitis Resolution [Maastricht Ankylosing Spondylitis Enthesitis Score (MASES = 0)] among Participants with any Enthesitis (MASES ≥ 1) at Baseline [Baseline (Week 0) to Week 52]

      The MASES evaluates the presence or absence of enthesitis at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right).

    20. Percentage of Participants with New Onset of Extra-articular Manifestations (EAMs) Among Participants with no History of EAMs [Up to Week 52]

      Percentage of participants with new onset for participants with no history of EAMs (e.g., uveitis and inflammatory bowel disease [IBD]).

    21. Percentage of Participants with Recurrence of EAMs among Participants with Previous History of EAMs [Up to Week 52]

      Percentage of participants with recurrence for participants with previous history of EAMs (e.g., uveitis and IBD).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of Radiographic Axial Spondylarthritis (r-axSpA) and meeting the modified New York Criteria for r-axSpA.

    • 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.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Italiano La Plata /ID# 230779 La Plata Buenos Aires Argentina 1902
    2 CER Instituto Medico /ID# 230782 Quilmes Buenos Aires Argentina 1878
    3 Instituto CAICI /ID# 230781 Rosario Santa Fe Argentina 2000
    4 Clinica Regional del Sud /ID# 248866 Rio Cuarto Argentina 5800
    5 Cimer /Id# 230780 San Miguel de Tucuman Argentina 4000
    6 Paratus Clinical /ID# 231460 Phillip Australian Capital Territory Australia 2606
    7 Genesis Research Services /ID# 231593 Broadmeadow New South Wales Australia 2292
    8 Campbelltown Hospital /ID# 231462 Campbelltown New South Wales Australia 2560
    9 Royal Prince Alfred Hospital /ID# 232417 Camperdown New South Wales Australia 2050
    10 BJC Health /ID# 230066 Paramatta New South Wales Australia 2150
    11 Barwon Rheumatology Services /ID# 230068 Geelong Victoria Australia 3220
    12 Peninsula Rheumatology /ID# 240172 Langwarrin Victoria Australia 3910
    13 Joint West Rheumatology /ID# 231461 Murdoch Western Australia Australia 6150
    14 Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 238961 Brussels Bruxelles-Capitale Belgium 1070
    15 Rhumaconsult SPRL /ID# 231439 Charleroi Hainaut Belgium 6000
    16 Onze Lieve Vrouw Hospital /ID# 238963 Aalst Belgium 9300
    17 AZ Sint-Jan Brugge /ID# 238964 Brugge Belgium 8000
    18 CHU Brugmann /ID# 238962 Bruxelles Belgium 1020
    19 Reumacentrum /ID# 231437 Genk Belgium 3600
    20 ReumaClinic /ID# 231438 Genk Belgium 3600
    21 Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 231440 Liege Belgium 4000
    22 AZ Damiaan /ID# 231441 Oostende Belgium 8400
    23 AZ-Delta /ID# 238966 Roeselare Belgium 8800
    24 UMHAT Kaspela EOOD /ID# 249621 Plovdiv Bulgaria 4001
    25 Medical center Unimed /ID# 249618 Plovdiv Bulgaria 4023
    26 Diagnostic consultative center 17 Sofia /ID# 249620 Sofia Bulgaria 1505
    27 Military Medical Academy Multiprofile Hospital /ID# 249623 Sofia Bulgaria 1606
    28 Artus Health Center /ID# 241966 Vancouver British Columbia Canada V5Z 1J9
    29 Manitoba Clinic /ID# 246217 Winnipeg Manitoba Canada R3A 1M3
    30 CIADS Research Co Ltd /ID# 247520 Winnipeg Manitoba Canada R3N 0K6
    31 Dr. Juris Lazovskis Inc. /ID# 246574 Sydney Nova Scotia Canada B1S 3N1
    32 The Waterside Clinic /ID# 248678 Barrie Ontario Canada L4M 6L2
    33 Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 246213 Dundas Ontario Canada L9H 1B7
    34 Arthur Karasik Medicine Professional Corporation /ID# 241932 Etobicoke Ontario Canada M9C 5N2
    35 Lau Bacchus Professional Medicine Corp /ID# 242591 Hamilton Ontario Canada L8N 1Y2
    36 Credit Valley Rheumatology /ID# 241948 Mississauga Ontario Canada L5M 2V8
    37 Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933 Windsor Ontario Canada N8X 1T3
    38 Applied Medical Informatics Research Inc. (AMIR) /ID# 246284 Montréal Quebec Canada H4A 3T2
    39 Groupe de Recherche en Maladies Osseuses Inc /ID# 241111 Sainte-foy Quebec Canada G1V 3M7
    40 CIUSSS de l'Estrie - CHUS /ID# 247572 Sherbrooke Quebec Canada J1G 2E8
    41 Dr. Latha Naik /ID# 246516 Saskatoon Saskatchewan Canada S7K 3H3
    42 HCL - Hôpital Lyon Sud /ID# 228819 Pierre Benite CEDEX Auvergne-Rhone-Alpes France 69495
    43 CHR Orleans - Hopital de la Source /ID# 234258 Orleans CEDEX 2 Centre-Val De Loire France 45067
    44 CHU de Besancon - Jean Minjoz /ID# 230528 Besancon Doubs France 25030
    45 CHU de Besancon - Jean Minjoz /ID# 242499 Besancon Doubs France 25030
    46 CHU Limoges - Dupuytren 1 /ID# 229094 Limoges CEDEX 1 Franche-Comte France 87042
    47 CHU Toulouse - Hopital Purpan /ID# 228818 TOULOUSE Cedex 9 Haute-Garonne France 31059
    48 CHU Montpellier - Hôpital Saint Eloi /ID# 228829 Montpellier Cedex 5 Herault France 34295
    49 CHU Montpellier - Hôpital Saint Eloi /ID# 240980 Montpellier Cedex 5 Herault France 34295
    50 CHU de SAINT ETIENNE - Hopital Nord /ID# 228836 St. Priest En Jarez Loire France 42270
    51 CHU Nice -Hopital Pasteur /ID# 229088 Nice CEDEX 1 Provence-Alpes-Cote-d Azur France 06002
    52 CHU Amiens-Picardie Site Sud /ID# 228821 Amiens CEDEX 1 Somme France 80054
    53 CH du Pays d'AIX /ID# 229095 Aix En Provence Cedex 1 France 13616
    54 Centre Hospitalier d'Arras /ID# 228833 Arras France 62022
    55 CHU Bordeaux - Hopital Pellegrin /ID# 230548 Bordeaux France 33000
    56 Infirmerie Protestante /ID# 228794 Caluire Et Cuire France 69300
    57 CHU Gabriel Montpied /ID# 229092 Clermont Ferrand France 63000
    58 C. H. Sud Francilien /ID# 228826 Corbeil Essonnes France 91106
    59 CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947 La Roche Sur Yon France 85000
    60 CHU Grenoble - Hopital Michallon /ID# 228792 La Tronche France 38700
    61 CHU Lille - Hôpital Roger Salengro /ID# 228820 Lille France 59037
    62 Clinique de la Sauvegarde /ID# 229087 Lyon France 69009
    63 AP-HM - Hopital Sainte Marguerite /ID# 241024 Marseille France 13009
    64 Cabinet de rhumatologie /ID# 229091 Mennecy France 91540
    65 CH Princesse Grace /ID# 228796 Monaco France 98000
    66 AP-HP - Hopital Saint-Antoine /ID# 228795 Paris France 75012
    67 Hopital Pitie Salpetriere /ID# 243309 Paris France 75013
    68 Centre de Soins Osteoarticulaires Ambulatoires /ID# 244737 Paris France 75015
    69 AP-HP - Hopital Bichat - Claude-Bernard /ID# 228837 Paris France 75018
    70 GH Diaconesses Croix Saint-Simon /ID# 238548 Paris France 75020
    71 Polyclinique Courlancy /ID# 229093 Reims France 51100
    72 CHU de Rennes - Hospital Sud /ID# 228842 Rennes CEDEX 2 France 35203
    73 Hôpital Charles-Nicolle /ID# 229096 Rouen France 76000
    74 Hôpital d'instruction des armées Bégin /ID# 228793 Saint-Mandé cedex France 94163
    75 CH Saint Nazaire /ID# 233186 St Nazaire France 44600
    76 General Hospital of Athens Ippokratio /ID# 241133 Athens Attiki Greece 11527
    77 General Hospital of Athens Laiko /ID# 241128 Athens Attiki Greece 11527
    78 University General Hospital of Heraklion PA.G.N.I /ID# 241124 Heraklion Kriti Greece 71500
    79 424 General MILITARY Hospital /ID# 241127 Efkarpia (Thessalonikis) Thessaloniki Greece 56429
    80 Naval Hospital of Athens /ID# 241129 Athens Greece 11521
    81 KAT Atttica General Hospital /ID# 243063 Athens Greece 14561
    82 Vougiouklakeio S.A. /ID# 246476 Egaleo Greece 12242
    83 Iaso /ID# 245137 Maroussi Greece 15123
    84 University General Hospital of Patras /ID# 243795 RION Patras Achaia Greece 26504
    85 Euromedica Blue Cross Gen Clin /ID# 244945 Thessaloniki Greece 54636
    86 General Hospital of Thessaloniki Hippokrateio /ID# 243796 Thessaloniki Greece 54642
    87 Euromedica General Clinic /ID# 241126 Thessaloniki Greece 54645
    88 Debreceni Egyetem Klinikai Kozpont /ID# 239936 Debrecen Hajdu-Bihar Hungary 4032
    89 Magyar Honvedseg Egeszsegugyi Kozpont /ID# 239939 Budapest Hungary 1134
    90 Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 239937 Debrecen Hungary 4031
    91 Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 239940 Heviz Hungary 8380
    92 Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 239938 Kecskemet Hungary 6000
    93 The Chaim Sheba Medical Center /ID# 241305 Ramat Gan Tel-Aviv Israel 5265601
    94 Tel Aviv Sourasky Medical Center /ID# 241864 Tel Aviv-Yafo Tel-Aviv Israel 6423906
    95 Hillel Yaffe Medical Center /ID# 241869 Hadera Israel 38100
    96 Bnai Zion Medical Center /ID# 241866 Haifa Israel 3339419
    97 The Lady Davis Carmel Medical Center /ID# 241867 Haifa Israel 34362
    98 Hadassah Medical Center-Hebrew University /ID# 241865 Jerusalem Israel 91120
    99 Meir Medical Center /ID# 241868 Kfar Saba Israel 4428164
    100 Galilee Medical Center /ID# 241870 Nahariya Israel 2210001
    101 Adan Hospital /ID# 229679 Adan Kuwait
    102 Jahra Hospital /ID# 229671 Jahra Kuwait 52700
    103 Farwaniya Hospital /ID# 231445 Kuwait City Kuwait 85000
    104 RM Pharma Specialists S.A de C.V. /ID# 238816 Mexico City Ciudad De Mexico Mexico 03100
    105 Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 238815 Guadalajara Jalisco Mexico 44650
    106 Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 238822 Guadalajara Jalisco Mexico 44690
    107 Desarrollos Biomedicos y Biotecnologicos /ID# 238818 Monterrey Nuevo Leon Mexico 64060
    108 Investigacion y Biomedicina de Chihuahua /ID# 238813 Chihuahua Mexico 31000
    109 Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 238824 Mexico City Mexico 06090
    110 Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 238817 Mexico City Mexico 11650
    111 Consultorio Privado Jorge Rojas Serrano /Id# 239512 Puebla Mexico 72550
    112 Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 243226 Bydgoszcz Kujawsko-pomorskie Poland 85-168
    113 Szpital Specjalistyczny im. J. Dietla w Krakowie /ID# 243228 Cracow Malopolskie Poland 31-121
    114 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji /ID# 243232 Warsaw Mazowieckie Poland 02-637
    115 Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 243225 Poznan Wielkopolskie Poland 61-545
    116 Jerzy Świerkot Indywidualna Specjalistyczna Praktyka Lekarska /ID# 244289 Oława Poland 55-200
    117 ChUZ Clinical Hospital RZD-Medicine /ID# 233185 Ulan-Ude Buryatiya, Respublika Russian Federation 670002
    118 Chelyabinsk Regional Clinical Hospital /ID# 244741 Chelyabinsk Chelyabinskaya Oblast Russian Federation 454087
    119 Regional Clinical Hospital of Kaliningrad region /ID# 238475 Kaliningrad Kaliningradskaya Oblast Russian Federation 236016
    120 LLC MC RevmaMed /ID# 238478 Syktyvkar Komi, Respublika Russian Federation 167031
    121 GBUZ RM "Mordovia Republican Central Clinical Hospital" /ID# 244738 Saransk Mordoviya, Respublika Russian Federation 430901
    122 Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510 Moscow Moskovskaya Oblast Russian Federation 129110
    123 Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479 Moscow Moskva Russian Federation 115522
    124 Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169 Samara Samarskaya Oblast Russian Federation 443095
    125 Nort-Western State Medical University n.a. Mechnikov /ID# 231172 St. Petersburg Sankt-Peterburg Russian Federation 193015
    126 City Clinical Hospital #52 /ID# 238477 Moscow Russian Federation 123182
    127 Orenburg State Medical University /ID# 233183 Orenburg Russian Federation 460000
    128 Republican hospital named after V.A. Baranov /ID# 231173 Petrozavodsk Russian Federation 185019
    129 Clinic of Samara State Medical University /ID# 241166 Samara Russian Federation 443079
    130 Clinical Rheumatologic Hospital No 25 /ID# 231171 St. Petersburg Russian Federation 190068
    131 Military Medical Academy n.a. Kirov /ID# 242363 St. Petersburg Russian Federation 194044
    132 Budgetary Institution of the Khanty-Mansiysk Autonomous Okrug-Yugra "Surgut Dist /ID# 242369 Surgut Russian Federation 628400
    133 Nebbiolo Clinical Research Center /ID# 231167 Tomsk Russian Federation 634009
    134 Ulyanovsk Regional Clinical Hospital /ID# 238334 Ulyanovsk Russian Federation 432017
    135 Yaroslavl State Medicat University /ID# 231168 Yaroslavl Russian Federation 150000
    136 Kantonsspital St. Gallen /ID# 230696 St. Gallen Sankt Gallen Switzerland 9007
    137 Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435 Weinfelden Thurgau Switzerland 8570
    138 Mediclinic Airport Road Hospital /ID# 231227 Abu Dhabi United Arab Emirates
    139 AlAin Hospital /ID# 233803 Dubai United Arab Emirates
    140 Mediclinic City Hospital /ID# 231226 Dubai United Arab Emirates
    141 Medica Uruguaya /ID# 231078 Montevideo Uruguay 11600

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04846244
    Other Study ID Numbers:
    • P20-410
    First Posted:
    Apr 15, 2021
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2022