The second interim analysis of Italian participants enrolled in the real-world, Pan-European, prospective, observational, Phase 4 PEARL study of fremanezumab effectiveness

Ethics approval and consent to participate

The protocol was approved by the Independent Ethics Committee or Institutional Review Board of all participating countries (Czech Republic, Denmark, Finland, Greece, Italy, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom). Local regulations, including relevant data protection laws, were followed. Individual informed consent was obtained, and participants agreed that their clinical data could be anonymously recorded.

Conflict of interest

FV has received travel grants, honoraria for advisory board, speaker panels, or clinical investigation studies from Allergan/AbbVie, Angelini, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals.

AA reports speakers’ fees from Eli Lilly, Novartis, Pfizer, and Teva Pharmaceuticals, and support for attending meetings from Teva Pharmaceuticals.

MB has nothing to declare.

SC has received travel grants, honoraria for advisory board, speaker panels, or clinical investigation studies from Allergan/AbbVie, Amgen, Angelini, BHV, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals.

GC has received travel grants, honoraria for advisory board, speaker panels, or clinical investigation studies from AbbVie, Eli Lilly, Pfizer, and Teva Pharmaceuticals.

FD’O declares disclosures with Organon.

RDS has received support for attending meetings from Eli Lilly and Teva Pharmaceuticals.

AG has received travel grants, honoraria for advisory board, speaker panels, or clinical investigation studies from Allergan/AbbVie, Eli Lilly, Novartis, and Teva Pharmaceuticals.

SG has received travel grants, honoraria for advisory board, speaker panels, or clinical investigation studies from AbbVie, Angelini, Eli Lilly, Lundbeck, Pfizer, and Teva Pharmaceuticals.

MPP has received consulting fees from Allergan/AbbVie, Eli Lilly, Fidia, Idorsia, Italfarmaco, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals; has received support for attending meetings and/or travel from Eli Lilly, Idorsia, Lundbeck, Novartis, Teva Pharmaceuticals, and Valeas.

IR has received honoraria for speaking from AbbVie, Eli Lilly, Lundbeck, Pfizer, and Teva Pharmaceuticals.

RR has received honoraria for speaker panels, advisory board, or clinical trial studies from AbbVie, Eli Lilly, Lundbeck, Pfizer, and Teva Pharmaceuticals.

CT has received honoraria for the lecturing at scientific symposia or for participating to advisory boards from Allergan/AbbVie, Biohaven, Dompé, Eli Lilly, Ipsen, Lundbeck, Pfizer, Teva Pharmaceuticals, and WebMD; has received research support from Allergan/AbbVie (to institution); is a PI in clinical trials for Allergan/AbbVie, Biohaven, Eli Lilly, Ipsen, Lundbeck, Pfizer, and Teva Pharmaceuticals.

PK and MC are employees and/or shareholders of Teva Pharmaceuticals.

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