A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING

Recruiting

• Conditions: Moderate to Severe Rheumatoid Arthritis

• Registration Number: NCT06712628
• Lead Sponsor: AbbVie

Brief Summary

This study will compare the retention rates for UPA vs. TNFi treatment in adult participants with moderate to severe active RA per local label and according to local standard of care

This is a mono-country, prospective, multi-center observational study in patients with moderate to severe active RA receiving UPA or TNFi therapy. Around 678 participants will be enrolled in approximately 80 sites in Germany.

Study recruitment will last approximately 24 months, and the study participation time will be up to 24 months, for a total study duration of approximately 48 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-07
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 678

Inclusion Criteria

• Current or Past participants with a confirmed diagnosis of moderate to severe active RA upon judgement of the treating physician.
• Physician decision on participant treatment with Upadacitinib (UPA) or tumor necrosis factor inhibitor (TNFi) must have been reached prior to and independently of recruitment in the study
• UPA or TNFi prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies

Exclusion Criteria

• Participation in a clinical trial with an investigational drug (within a minimum of 30 days or 5 half-lives of the investigational drug [whichever is longer] prior to baseline)
• Prior treatment with Upadacitinib
• Prior treatment with the same tumor necrosis factor inhibitor as the one prescribed for this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention Rate of UPA vs TNFi	Up to approximately 24 months	Time to the discontinuation of Upadacitinib. Time to the discontinuation of Tumor Necrosis Factor Inhibitor treatment

Trial Locations

Locations (42)

Rheumapraxis Heidelberg /ID# 276475; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Rheumapraxis Haas Tübingen /ID# 275536; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany

Rheumapraxis Ulm Dr. med. Nadia Rinaldi /ID# 276293; 🇩🇪 Ulm, Baden-Wuerttemberg, Germany

Dr. Med. Thomas Marycz /ID# 274646; 🇩🇪 Amberg, Bayern, Germany

Rheumapraxis Am Webereck /ID# 274412; 🇩🇪 Augsburg, Bayern, Germany

Dr. Harmuth /ID# 273401; 🇩🇪 Marktredwitz, Bayern, Germany

Praxiszentrum Dr. Med. Klaus Krüger Dres. Günther Kellerer Und Paul Kellerer /ID# 276138; 🇩🇪 Munich, Bayern, Germany

Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 274587; 🇩🇪 Planegg, Bayern, Germany

Private Practice - Dr. Dirk Wernicke /ID# 276820; 🇩🇪 Hohen Neuendorf, Brandenburg, Germany

Rheumahaus Studien GbR /ID# 275917; 🇩🇪 Potsdam, Brandenburg, Germany

Rheumatologisch Immunologisch /ID# 275830; 🇩🇪 Templin, Brandenburg, Germany

Rheumatism Center Mittelhessen /ID# 274641; 🇩🇪 Bad Endenbach, Hessen, Germany

Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 274291; 🇩🇪 Frankfurt am Main, Hessen, Germany

Private Practice - Dr. Thilo Klopsch - Stargarder Strasse /ID# 276367; 🇩🇪 Neubrandenburg, Mecklenburg-Vorpommern, Germany

Rheumapraxis Hannover-List /ID# 273735; 🇩🇪 Hanover, Niedersachsen, Germany

Praxis. F. Bigdeli-Wilshusen /ID# 273455; 🇩🇪 Hanover, Niedersachsen, Germany

Rheumatologie Kassel /ID# 275916; 🇩🇪 Kassel, Niedersachsen, Germany

Rheumapraxis An Der Hase /ID# 276949; 🇩🇪 Osnabrück, Niedersachsen, Germany

Fachpraxis für Rheumatologie und Osteologie /ID# 275359; 🇩🇪 Weyhe, Niedersachsen, Germany

Rheumazentrum Ruhrgebiet /ID# 275518; 🇩🇪 Herne, Nordrhein-Westfalen, Germany

Rheumazentrum Ratingen /ID# 275707; 🇩🇪 Ratingen, Nordrhein-Westfalen, Germany

Praxis Dr. med. Florian Beyer /ID# 274293; 🇩🇪 Kaiserslautern, Rheinland-Pfalz, Germany

Rheumapraxis am Schlossberg /ID# 272728; 🇩🇪 Homburg, Saarland, Germany

Dr. Murawski /ID# 272724; 🇩🇪 Neunkirchen, Saarland, Germany

Rheumapraxis Dr. Liebhaber /ID# 274888; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Rheumatologische Facharztpraxis /ID# 272866; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Medizinischen Versorgungszentrums Agilomed /ID# 274887; 🇩🇪 Chemnitz, Sachsen, Germany

Dr. Mueller /ID# 273081; 🇩🇪 Freiberg, Sachsen, Germany

Private Practice - Dr. Frank Hamann, Dr. Andreas Teich & Dr. Konrad Boche /ID# 275358; 🇩🇪 Leipzig, Sachsen, Germany

Private Practice - Dr. Ilka Schwarze /ID# 276981; 🇩🇪 Leipzig, Sachsen, Germany

Private Practice - Dr. Christine Baumann /ID# 275095; 🇩🇪 Plauen, Sachsen, Germany

Praxis H. Fricke-Wagner /ID# 274467; 🇩🇪 Zwickau, Sachsen, Germany

Private Practice - Dr. Thomas Kupka /ID# 273631; 🇩🇪 Altenburg, Thueringen, Germany

Rheumapraxis Weimar /ID# 272740; 🇩🇪 Weimar, Thueringen, Germany

MVZ Weserbergland /ID# 276009; 🇩🇪 Bad Pyrmont, Germany

Private Practice - Dr. Silke Zinke /ID# 276366; 🇩🇪 Berlin, Germany

MVZ Herzogin Elisabeth Hospital /ID# 272725; 🇩🇪 Brunswick, Germany

Dres. Schuh /ID# 272731; 🇩🇪 Coburg, Germany

Rheumapraxis Düren /ID# 272726; 🇩🇪 Düren, Germany

Praxis Dilltal /ID# 272727; 🇩🇪 Ehringshausen, Germany

Dr. Bestler /ID# 272741; 🇩🇪 Erfurt, Germany

Rheumatologische Facharztpraxis /ID# 272743; 🇩🇪 Naumburg (Saale), Germany