Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among … (NCT03452501) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients
Saudi Arabia157 participantsStarted 2018-08-26
Plain-language summary
The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the daily practice will be performed.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* \- Adult patients with moderate to severe active CD who have not responded despite a full and adequate course of therapy with corticosteroids and/or immunosuppressive agents, or who are intolerant to or have medical contraindications to such therapies.
* Adult patients with fistulizing active CD who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
* Adult patients with moderate to severe active UC who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant or have medical contraindications to such therapies.
* Switched patients who received at least one dose of Infliximab reference medicinal product (RMP) before the first infusion of Remsima®.
* Patients who agree to join the study and give a written informed consent
Exclusion Criteria:
* \- Patients with a known history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients (Sucrose, Polysorbate 80, Monobasic sodium phosphate and/or Dibasic sodium phosphate).
* Patients who have shown intolerance or inefficacy to biologics for IBD treatment.
* Female patients who are known to be pregnant or breastfeeding.
* Patients with a past or present history of chronic infection with Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV), or those with positive test…