A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Moderate to Severe Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING
Overview
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.
Primary outcome measures
- Retention Rate of UPA vs TNFi [Time frame: Up to approximately 24 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 72 centers
- Gemeinschaftspraxis Innere Medizin/Rheumatologie /ID# 278584 — Freiburg im Breisgau
- Rheumapraxis Heidelberg /ID# 276475 — Heidelberg
- Rheumapraxis Haas Tubingen /ID# 275536 — Tübingen
- Rheumapraxis Ulm Dr. med. Nadia Rinaldi /ID# 276293 — Ulm
- Dr. Med. Thomas Marycz /ID# 274646 — Amberg
- Rheumapraxis Am Webereck /ID# 274412 — Augsburg
- Dr. Harmuth /ID# 273401 — Marktredwitz
- Praxiszentrum Dr. Med. Klaus Kruger Dres. Günther Kellerer Und Paul Kellerer /ID# 276138 — Munich
- … and 64 more centers
Identifiers
NCT: NCT06712628 · P25-188