Last updated on May 2018

A clinical trial to evaluate treatments using Inflectra (infliximab) for patients with Ulcerative Colitis, Inflammatory bowel disease, Crohn's Disease


Brief description of study

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra (infliximab) or Remicade (infliximab) for treatment. Inflectra is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:

  • To characterize the population and drug utilization patterns of patients treated with Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
  • To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of patients with CD or UC in the context of standard of care Remicade
  • To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in the context of standard of care Remicade
  • To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD or UC
  • To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work productivity and healthcare resource utilization (HRU) in patients treated with Inflectra for CD or UC

Detailed Study Description

The study will be conducted according to good clinical practice (GCP) guidelines and data source will be validated. The source data will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into an web based electronic data capture (EDC) system at enrolment and then approximately every 3 months thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be of 3300 patients recruited over 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.

Clinical Study Identifier: NCT02539368

Contact Investigators or Research Sites near you

Start Over

Kreiskliniken Altotting-Burghausen
Burghausen, Germany
7.77miles