Observational, real-world study of INFLECTRA in patients with inflammatory bowel disease (IBD) in the United States and Canada (ONWARD)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  INFLIXIMAB
• Medical condition to be studied:
  Inflammatory bowel disease

  Colitis ulcerative

  Crohn's disease

Population studied

• Short description of the study population:
  Patients in the US and Canada initiating treatment with infliximab-dyyb for IBD.; ; Patients are eligible to participate if they have:; 1. Initiated therapy with INFLECTRA as their first biologic;; 2. Switched to INFLECTRA while in remission on a stable dose of REMICADE; or,; 3. Switched to INFLECTRA from another biologic, due to non-responsiveness, intolerance, or other reasons.; ; Inclusion Criteria:; Patients must meet all of the following criteria to be eligible for inclusion in the study:; 1. Patients with confirmed diagnosis of Ulcerative Colitis or Crohn’s Disease.; 2. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.; 3. Patient eligible to receive INFLECTRA for the treatment of their disease per approved drug label (patients with fistula, or stoma are eligible).; ; Exclusion Criteria; Patients meeting any of the following criteria will not be included in the study:; 1. Patient age less than 18 years at the time of consent.; 2. Patient previously failed treatment with REMICADE or INFLECTRA/CT-P13.; 3. Any reported contraindications for INFLECTRA/CT-P13 or REMICADE.; 4. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.; 5. Patients with communication difficulties in reading or understanding the study consent or questionnaires
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization.
• Outcomes:
  Exposure variables are limited to the dosing and timing of administration of INFLECTRA, as well as the dose and frequency of disease related concomitant medications. Outcomes variables are primarily limited to the responses from various patients reported outcomes including the Harvey-Bradshaw Index (HBI), partial MAYO score, Simplified Inflammatory Bowel Disease questionnaire (SIBDQ), To describe real world clinical and economic outcomes in adult UC and CD cohorts who initiated therapy with INFLECTRA as their first biologic, switched to INFLECTRA from REMICADE or, switched to INFLECTRA from another biologicTo describe real world patient reported quality of life in both the UC and CD cohorts who initiated therapy with INFLECTRA as their first biologic, switched to INFLECTRA
• Data analysis plan:
  This study will be primarily descriptive in nature. All categorical endpoints will be summarized using both the number and percentage in each category. Continuous endpoints will be summarized in the form of means, standard deviation (SD), median, interquartile ranges (IQR) and range, a 95% confidence interval (CI) for the mean will also be computed. Pearson’s chi squared tests will be used for bivariate statistical testing of categorical and ordinal outcomes. Student’s t tests or 1 way ANOVA will be used for comparisons of continuous outcomes. For highly skewed, non normally distributed endpoints or sample sizes under 30 in either group, non parametric Wilcoxon rank sum test will be applied. All inferences will be made assuming a two sided test with an alpha of 0.05 without adjustment for multiplicity. Approaches to controlling for baseline differences between groups such as inverse probability weights may be considered.