Upadacitinib: Rinvoq

Zulassungsnummer 67257, Zulassungsdatum: 20.1.2020

Wir publizieren Synopsen aus Clinical Study Reports (CSR), um die öffentlichen Informationen zu ergänzen. Dadurch stehen Patienten und Gesundheitsdienstleistern die Ergebnisse unserer klinischen Studien und die zur Zulassung von Rinvoq verwendeten Nachweise zur Verfügung.

Finden Sie hier die CSR-Synopsen nach Erhalt der Zulassung von Rinvoq in der Schweiz und den USA.

Studienindikation: Rheumatoide Arthritis
Phase: Phase 3
Studienname:
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoide Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
EudraCT-Number: 2015-003335-35

Studienindikation: Rheumatoide Arthritis
Phase: Phase 3
Studienname:
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoide Arthritis
EudraCT-Number: 2015-003334-27

Studienindikation: Rheumatoide Arthritis
Phase: Phase 3
Studienname:
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoide Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
EudraCT-Nummer: 2015-003332-13

Studienindikation: Rheumatoide Arthritis
Phase: Phase 3
Studienname:
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoide Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
EudraCT-Nummer: 2015-003333-95

Studienindikation: Rheumatoide Arthritis
Phase: Phase 3
Studienname:
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoide Arthritis With Inadequate Response to MTX
EudraCT-Nummer: 2015-003376-75