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
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-11-07
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Status Verified: 2024-12
• Study First Posted: 2024-12-02
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• 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

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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

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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 (8)

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

Rheumazentrum Kupka /ID# 273631; 🇩🇪 Altenburg, Thueringen, Germany

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

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

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

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

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

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