Reflections b538-12
WebThe Prior Approval Supplement is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis (RA). Results showed that the study met its primary endpoint demonstrating pharmacokinetic equivalence in ... WebPositive topline results from the REFLECTIONS B538-12 trial, which investigated numerous switches between ABRILADA and its reference medication, Humira, both of which were taken with methotrexate in adult patients with moderate to severe rheumatoid arthritis, backed up the PAS (RA). Curious about this latest version of the report?
Reflections b538-12
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WebSep 25, 2024 · Background/objective: REFLECTIONS B538-02 is a randomized, double-blind comparative study of the adalimumab (ADL) biosimilar PF-06410293, (ADL-PF), and … WebThe PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA). The study met its primary goal by ...
WebJun 6, 2013 · Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. WebSep 11, 2014 · A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) (B538-07) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for …
WebFeb 27, 2024 · New Delhi: Pfizer Inc. has announced that the U.S. Food and Drug Administration (USFDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). WebFeb 27, 2024 · With biosimilar sponsors having to generate ancillary clinical trial data to achieve a designation, Pfizer’s PAS was supported by positive topline data from its …
WebNov 2, 2024 · Abrilada (adalimumab-afzb, biosimilar) -- In September 2024, Pfizer received positive topline results from the REFLECTIONS B538-12 study which evaluated multiple …
WebA Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07)) Overview. Status: Completed: Phase: Phase 1: Sponsor: Pfizer: Start date: September 2014: End date: March 2015: Enrollment: 362 participants: Identifiers: NCT02237729, B5381007, REFLECTIONS B538-07: ... 12 lead ECG and clinical ... crypt of chance scratchcard neopetsWebFeb 7, 2024 · Positive topline results from the REFLECTIONS B538-12 trial, which investigated numerous switches between ABRILADA and its reference medication, Humira, both of which were taken with methotrexate... crypt of chaos reviewcrypt of chaos board gameWebMar 18, 2024 · The application for interchangeability was supported by positive data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment … crypt of charlie gehringerWebMar 3, 2024 · The PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with Abrilada and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA). crypt of chaos gameWebJan 8, 2024 · Pfizer has reported positive top-line data from its REFLECTIONS B538-02 study of PF-06410293 compared with Humira to treat moderate-to-severe rheumatoid arthritis (RA). crypt of all soulsWebJan 19, 2024 · The primary endpoint is an equivalent ACR20 response (≥20% improvement by ACR criteria) at Week 12 of study treatment. More information about the REFLECTIONS B538-02 study can be found at www.clinicaltrials.gov(link is external) . crypt of chaos