MLN-0002_401: Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease (Entyvio PASS study)

First published 27/05/2014

Last updated 24/10/2024

EU PAS number:

EUPAS6469

Study

Finalised

Documents

Study protocol

Initial protocol

Vedolizumab PASS study (MLN-002-401) protocol Final_v1_2

English (437.28 KB - PDF)View document

Updated protocol

MLN0002_401-Protocol-V3.1-Redacted

First published: 22/02/2024

English (7.91 MB - PDF)View document

Study results

MLN-0002_401 RDS Amended 9May2023

English (787.08 KB - PDF)View document

MLN0002_401_RDS_11Jul2022

English (715.37 KB - PDF)View document

MLN0002_401-clinical-study-report-redact.pdf

English (781.51 KB - PDF)View document

Study report

Other information

Study, other information

MLN0002_401 PASS protocol version 3 (Belgium- web without FACIT) 14 Sept 2015

English (1.92 MB - PDF)View document

MLN0002_401 PASS protocol version 3 (Canada) 14 Sept 2015

English (1.82 MB - PDF)View document

ENCePP Seal

ENCePP Seal documents

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