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.
A multicenter, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in newly diagnosed and in switched IBD patients diagnosed with active Crohn's disease (CD), fistulizing CD, or Ulcerative Colitis (UC). Each patient is expected to be treated for a total of 38 weeks if naive or 40 weeks if switched. The study duration will be between 46 and 48 weeks (up to 12 months). Follow-up is expected to end 8 weeks after the last treatment visit.
Study Type
OBSERVATIONAL
Enrollment
157
A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg
King Abdulaziz University Hospital
Jeddah, Saudi Arabia
Prince Sultan Military Medical City
Riyadh, Saudi Arabia
King Abdullah International Medical Research Center
Riyadh, Saudi Arabia
King Saud Medical City
Riyadh, Saudi Arabia
Incidence of adverse events (AEs) to Remsima®
Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests (according to laboratory reference ranges), in addition to the incidence of latent tuberculosis (TB) activation (as an adverse event) and the incidence of hepatitis B virus HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) will be assessed
Time frame: 12 months
Proportions of naïve patients with CD achieving clinical response or remission based on Crohn's Disease Activity Index (CDAI)
Clinical response is defined by a decrease in CDAI score from baseline of at least 70 points (Response-70). Clinical remission score \< 150 for naïve patients with CD
Time frame: Up to 12 months
Proportion of switched patients with CD achieving disease control
Disease control is defined as the absence of disease worsening, with worsening defined as increase in CDAI of 70 points or more from the qualifying score with a total score of 175 or more and an increase in CDAI of 35% or more from baseline, or the introduction of a new treatment for active CD
Time frame: Up to 12 months
Proportion of naïve patients with fistulizing CD achieving clinical response or remission
Clinical response is defined as reduction of at least 50% from baseline in the number of draining fistulas. Clinical remission is defined as the absence of draining fistulas
Time frame: Up to 12 months
Proportion of switched patients with fistulizing CD achieving disease control
Disease control is defined as no loss of response, with loss of response defined as the recrudescence of draining fistulas, the need for a change in medication for CD, the need for additional therapy for persistent or worsening luminal disease activity, the need for a surgical procedure for CD, or the discontinuation of study medication owing to a perceived lack of effectiveness
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Time frame: Up to 12 months
Proportion of naïve patients with UC achieving clinical response or remission based on Partial Mayo Score and mucosal healing
Clinical response is defined as a decrease in partial Mayo scores from baseline of 2 points or more and 30% or more, with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or an absolute subscore for rectal bleeding of 0 or 1). Clinical remission is defined as a total partial Mayo score of 2 points or less, with no individual sub-score of more than 1 point), Mucosal healing (assessed through endoscopy, and defined by Mayo endoscopic subscore of 1 point or less)
Time frame: Up to 12 months
Proportion of switched patients with UC achieving disease control.
Disease control is defined as the absence of disease worsening, with worsening defined by an increase in partial Mayo score of 3 points or more from baseline \[before switching\] and a partial Mayo score of 5 points or more).
Time frame: Up to 12 months