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)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, observational, multi-center study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Medical condition to be studied:
  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  Patients with UC or CD who were initiating vedolizumab therapy were recruited into the vedolizumab cohort. Patients may have had prior exposure to biologics or were naïve to biologics. Patients were to be naïve to vedolizumab at study entry. Patients with UC or CD who initiated therapy with another biologic agent indicated for UC or CD were recruited into the other biologic agents cohort. Patients may have had prior exposure to biologic agents or were naïve to biologics. Patients may not have had prior exposure to vedolizumab at study entry.; ; Inclusion Criteria:; - Signed informed consent, by the patient or a legally acceptable representative, obtained before any study-related activities were undertaken.; - Male and female patients, aged at least 18 years.; - Initiated vedolizumab or initiated a biologic agent for UC or CD (where possible patients were recruited on or before day of first dose of vedolizumab or other biologic agent. To help fit recruitment around busy clinics, patients were recruited up to 2 weeks after first dose of vedolizumab or other biologic).; - Signed release form, by the patient or a legally acceptable representative, that permitted abstraction of the patient’s medical records at baseline and during participation in the study.; Exclusion Criteria:; - The patient was enrolled in a clinical trial in which treatment for UC or CD was managed through a protocol.; - Prior treatment with vedolizumab
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  To assess the long-term safety of vedolizumab versus other biologic agents in patients with Ulcerative Colitis or Crohn's Disease.
• Outcomes:
  The primary outcome measures is serious infections (infections that are SAEs and opportunistic infections such as PML). The secondary safety outcomes include: gastrointestinal infections, respiratory infections, malignancies, hepatic injury, and hypersensitivity. Effectiveness endpoints include change in disease severity, change in biomarker levels, use of corticosteroids, IBD-related surgery, use of health care resources, and change in patient reported outcomes.
• Data analysis plan:
  The primary safety analysis will focus on serious infections. Secondary analyses will look at individual serious infections, including PML, and the other Adverse Events of Special Interest. The safety analyses will present number of events, person-years of follow-up and crude incidence rates in each cohort. Time varying Cox proportional hazard models, with propensity score stratification will be used to generate adjusted hazard ratios. Analyses will be presented for all patients, and separately for UC and CD patients. Multivariate analysis with adjustment for confounders will assess risks with respect to duration of use, cumulative dose, and time since first use of vedolizumab. Other SAEs, adverse reactions and pregnancy data will be summarized by cohort with stratification by baseline characteristics.

Documents

Study results

MLN-0002_401 RDS Amended 9May2023

MLN0002_401_RDS_11Jul2022

MLN0002_401-clinical-study-report-redact.pdf

Study, other information

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

MLN0002_401 PASS protocol version 3 (Canada) 14 Sept 2015