Psoriatic Arthritis Clinical Trial
— UPtimum-PsAOfficial title:
Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients
| NCT number | NCT05616871 |
| Other study ID # | P22-897 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 15, 2022 |
| Est. completion date | July 31, 2027 |
Psoriatic arthritis (PsA) is a chronic, immune-mediated, systemic disease affecting less than 1% of people with variations by parts of the world, and around 20%-30% of participants with psoriasis. Upadacitinib (RINVOQ) is approved drug for the treatment of adult participants with active PsA in Europe. Approximately 450 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 4 countries in Europe: France, Germany, Greece and Italy. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 24 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
| Status | Recruiting |
| Enrollment | 450 |
| Est. completion date | July 31, 2027 |
| Est. primary completion date | July 31, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Confirmed diagnosis of active psoriatic arthritis (PsA) whose peripheral involvement justifies the prescription of upadacitinib upon judgement of the treating physician. - 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 applicable approved label and local regulatory and reimbursement policies. - Participants able to understand and communicate with the investigator and comply with the requirements of the study. Exclusion Criteria: - Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. - Prior treatment with upadacitinib. |
| Country | Name | City | State |
|---|---|---|---|
| France | CH AIX LES BAIN - Reine Hortense /ID# 252465 | Aix Les Bains | |
| France | CHU Amiens-Picardie Site Sud /ID# 252527 | Amiens CEDEX 1 | Somme |
| France | Cabinet Médical Dr ALBERT-SABONNADIERE /ID# 252523 | Antibes | |
| France | Centre Hospitalier d'Arras /ID# 252529 | Arras | |
| France | CH Henri Duffaut /ID# 252620 | Avignon CEDEX 9 | Vaucluse |
| France | Ch Beauvais /Id# 252464 | Beauvais CEDEX | Oise |
| France | CHU Bordeaux - Hopital Pellegrin /ID# 252532 | Bordeaux | Gironde |
| France | Centre Hospitalier de Boulogne Sur Mer /ID# 252467 | Boulogne sur Mer | |
| France | Infirmerie Protestante /ID# 252075 | Caluire Et Cuire | Rhone |
| France | CH de Cannes - Simone Veil /ID# 252600 | Cannes | |
| France | CHRU Tours - Hopital Trousseau /ID# 252528 | Chambray Les Tours | |
| France | C. H. Sud Francilien /ID# 254945 | Corbeil Essonnes | |
| France | CH La Rochelle - Hopital Saint Louis /ID# 252534 | La Rochelle | |
| France | CHU Grenoble - Hopital Michallon /ID# 252601 | La Tronche | Isere |
| France | CHU Limoges - Dupuytren 1 /ID# 252432 | Limoges CEDEX 1 | Franche-Comte |
| France | ELSAN - Clinique du Pont de Chaume /ID# 252602 | Montauban | |
| France | CHU Montpellier - Hopital Saint Eloi /ID# 252078 | Montpellier Cedex 5 | Herault |
| France | CH de Narbonne /ID# 252525 | Narbonne | |
| France | CHU Nice -Hopital Pasteur /ID# 252536 | Nice CEDEX 1 | Provence-Alpes-Cote-d Azur |
| France | Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252530 | Orléans | |
| France | GH Diaconesses Croix Saint-Simon /ID# 252463 | Paris | |
| France | Cabinet libéral du Dr PAUPIERE /ID# 252604 | Peronne | Somme |
| France | CHU de Rennes - Hospital Sud /ID# 252478 | Rennes CEDEX 2 | |
| France | Hôpital Charles-Nicolle /ID# 252603 | Rouen | |
| France | Cabinet Du Dr Judith Payet Dubourg /Id# 252668 | St Pierre | |
| France | CHU Toulouse - Hopital Purpan /ID# 252077 | TOULOUSE Cedex 9 | Haute-Garonne |
| France | CH Troyes - Hopital Simone Veil /ID# 252625 | Troyes | Aube |
| Germany | Kupka & Kupka, Altenburg, DE /ID# 254758 | Altenburg | |
| Germany | Praxis Dr. Silke Zinke /ID# 258037 | Berlin | |
| Germany | Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 258152 | Berlin | |
| Germany | MVZ Herzogin Elisabeth Hospital /ID# 266740 | Brunswick | |
| Germany | Praxis Dilltal /ID# 254761 | Ehringshausen | |
| Germany | MVZ Ambulantes Rheumazentrum Erfurt /ID# 256115 | Erfurt | |
| Germany | Universitaetsmedizin Greifswald /ID# 254756 | Greifswald | |
| Germany | Dr. Heintz /ID# 254757 | Hamburg | |
| Germany | Rheumazentrum Ruhrgebiet /ID# 252939 | Herne | |
| Germany | Beyer, Kaiserslautern, DE /ID# 254754 | Kaiserslautern | |
| Germany | Dr. Bolze, Ludwigshafen, DE /ID# 254134 | Ludwigshafen | |
| Germany | Aurich & Sieburg, Magdeburg /ID# 255504 | Magdeburg | |
| Germany | RHIO Forschungsinstitut /ID# 254752 | Meerbusch | |
| Germany | Prof-med-stud.de /ID# 265965 | Munich | |
| Germany | Dr. Murawski /ID# 257911 | Neunkirchen | Saarland |
| Germany | Knappschaftsklinikum Saar /ID# 255505 | Puettlingen | |
| Germany | Rheumapraxis Dr. Prothmann /ID# 254759 | Püttlingen | Saarland |
| Germany | Krankenhaus der Barmherzigen Brüder Trier /ID# 254762 | Trier | |
| Germany | Krankenhaus St. Josef /ID# 254755 | Wuppertal | |
| Greece | 251 Airforce General Hospital /ID# 248092 | Athens | Attiki |
| Greece | General Hospital of Athens Gennimatas /ID# 247635 | Athens | Attiki |
| Greece | General Hospital of Athens Ippokratio /ID# 247633 | Athens | Attiki |
| Greece | General Hospital of Athens Laiko /ID# 247634 | Athens | Attiki |
| Greece | General Hospital of Athens Laiko /ID# 258030 | Athens | Attiki |
| Greece | Henry Dunnant Hospital Center /ID# 247640 | Athens | Attiki |
| Greece | KAT Atttica General Hospital /ID# 247641 | Athens | |
| Greece | Naval Hospital of Athens /ID# 247631 | Athens | |
| Greece | University General Hospital Attikon /ID# 248093 | Athens | Attiki |
| Greece | University General Hospital of Heraklion PA.G.N.I /ID# 247632 | Heraklion | Kriti |
| Greece | University General Hospital of Ioannina /ID# 251899 | Ioannina | |
| Greece | Iaso Thessalias S.A. /Id# 255110 | Larisa | |
| Greece | Reg Gen Univ Hosp Larissa /ID# 247642 | Larisa | |
| Greece | General Hospital of Elefsina Thriassio /ID# 251900 | Magoula (Attikis) | |
| Greece | Iaso /ID# 247649 | Maroussi | |
| Greece | Olympion General Clinic /ID# 247644 | Patras | Achaia |
| Greece | Bioclinic Thessaloniki /ID# 247648 | Thessaloniki | |
| Greece | Euromedica Blue Cross Gen Clin /ID# 251898 | Thessaloniki | |
| Greece | Euromedica General Clinic /ID# 251897 | Thessaloniki | |
| Greece | General Hospital of Thessaloniki Hippokrateio /ID# 247643 | Thessaloniki | |
| Italy | Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 251508 | Bari | |
| Italy | Universita degli Studi del Molise /ID# 251176 | Campobasso | |
| Italy | Ospedale San Raffaele IRCCS /ID# 251562 | Milan | Milano |
| Italy | AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 251183 | Napoli | |
| Italy | Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 250789 | Palermo | |
| Italy | Fondazione IRCCS Policlinico /ID# 250747 | Pavia | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 250669 | Rome | Lazio |
| Italy | Fondazione PTV Policlinico Tor Vergata /ID# 250817 | Rome | Roma |
| Italy | Istituto Clinico Humanitas /ID# 251275 | Rozzano | Milano |
| Italy | Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 251146 | Siena | |
| Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 250819 | Torette | Ancona |
| Italy | Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 251544 | Udine |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
France, Germany, Greece, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Disease Activity in Psoriatic Arthritis (DAPSA): score <=14 | Disease Activity in Psoriatic Arthritis (DAPSA) score is calculated by the sum of values of rheumatic parameters [tender joint count (TJC/ 68) + swollen joint count (SJC/ 66) + visual analog scale VAS Patient Global Disease Activity (PtGA) in cm + VAS Patient Pain in cm + C Reactive Protein (CRP) in mg/dL]. | Month 6 |
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