Clinical trial NCT06712628: A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING
Official title: Comparison of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate to Severe Rheumatoid Arthritis
Keywords: Moderate to Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Upadacitinib
Tumor Necrosis Factor Inhibitor Treatment
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-12-02
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with moderate to severe active Rheumatoid Arthritis receiving Upadcitinib or a Tumor necrosis factor inhibitor treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Retention Rate of UPA vs TNFi
timeFrame: Up to approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Rheumapraxis Heidelberg /ID# 276475
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Rheumapraxis Haas Tübingen /ID# 275536
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Rheumapraxis Ulm Dr. med. Nadia Rinaldi /ID# 276293
state: Baden-Wuerttemberg
city: Amberg
country: Germany
facility: Dr. Med. Thomas Marycz /ID# 274646
state: Bayern
city: Augsburg
country: Germany
facility: Rheumapraxis Am Webereck /ID# 274412
state: Bayern
city: Marktredwitz
country: Germany
facility: Dr. Harmuth /ID# 273401
state: Bayern
city: Munich
country: Germany
facility: Praxiszentrum Dr. Med. Klaus Krüger Dres. Günther Kellerer Und Paul Kellerer /ID# 276138
state: Bayern
city: Planegg
country: Germany
facility: Klinische Forschung Im Medizinischen Versorgungalltag Gbr /ID# 274587
state: Bayern
city: Hohen Neuendorf
country: Germany
facility: Private Practice - Dr. Dirk Wernicke /ID# 276820
state: Brandenburg
city: Potsdam
country: Germany
facility: Rheumahaus Studien GbR /ID# 275917
state: Brandenburg
city: Templin
country: Germany
facility: Rheumatologisch Immunologisch /ID# 275830
state: Brandenburg
city: Bad Endenbach
country: Germany
facility: Rheumatism Center Mittelhessen /ID# 274641
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Deutsches Endokrinologisches Versorgungszentrum DEVZ - MVZ GdR /ID# 274291
state: Hessen
city: Neubrandenburg
country: Germany
facility: Private Practice - Dr. Thilo Klopsch - Stargarder Strasse /ID# 276367
state: Mecklenburg-Vorpommern
city: Hanover
country: Germany
facility: Rheumapraxis Hannover-List /ID# 273735
state: Niedersachsen
city: Hanover
country: Germany
facility: Praxis. F. Bigdeli-Wilshusen /ID# 273455
state: Niedersachsen
city: Kassel
country: Germany
facility: Rheumatologie Kassel /ID# 275916
state: Niedersachsen
city: Osnabrück
country: Germany
facility: Rheumapraxis An Der Hase /ID# 276949
state: Niedersachsen
city: Weyhe
country: Germany
facility: Fachpraxis für Rheumatologie und Osteologie /ID# 275359
state: Niedersachsen
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 275518
state: Nordrhein-Westfalen
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen /ID# 275707
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
facility: Praxis Dr. med. Florian Beyer /ID# 274293
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Rheumapraxis am Schlossberg /ID# 272728
state: Saarland
city: Neunkirchen
country: Germany
facility: Dr. Murawski /ID# 272724
state: Saarland
city: Halle
country: Germany
facility: Rheumapraxis Dr. Liebhaber /ID# 274888
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Rheumatologische Facharztpraxis /ID# 272866
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Medizinischen Versorgungszentrums Agilomed /ID# 274887
state: Sachsen
city: Freiberg
country: Germany
facility: Dr. Mueller /ID# 273081
state: Sachsen
city: Leipzig
country: Germany
facility: Private Practice - Dr. Frank Hamann, Dr. Andreas Teich & Dr. Konrad Boche /ID# 275358
state: Sachsen
city: Leipzig
country: Germany
facility: Private Practice - Dr. Ilka Schwarze /ID# 276981
state: Sachsen
city: Plauen
country: Germany
facility: Private Practice - Dr. Christine Baumann /ID# 275095
state: Sachsen
city: Zwickau
country: Germany
facility: Praxis H. Fricke-Wagner /ID# 274467
state: Sachsen
city: Altenburg
country: Germany
facility: Private Practice - Dr. Thomas Kupka /ID# 273631
state: Thueringen
city: Weimar
country: Germany
facility: Rheumapraxis Weimar /ID# 272740
state: Thueringen
city: Bad Pyrmont
country: Germany
facility: MVZ Weserbergland /ID# 276009
city: Berlin
country: Germany
facility: Private Practice - Dr. Silke Zinke /ID# 276366
city: Brunswick
country: Germany
facility: MVZ Herzogin Elisabeth Hospital /ID# 272725
city: Coburg
country: Germany
facility: Dres. Schuh /ID# 272731
city: Düren
country: Germany
facility: Rheumapraxis Düren /ID# 272726
city: Ehringshausen
country: Germany
facility: Praxis Dilltal /ID# 272727
city: Erfurt
country: Germany
facility: Dr. Bestler /ID# 272741
city: Naumburg (Saale)
country: Germany
facility: Rheumatologische Facharztpraxis /ID# 272743
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: