Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

Launched by HIKMA PHARMACEUTICALS LLC · Feb 26, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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 at screening.
• • Patients who are diagnosed with tuberculosis (TB) or previously diagnosed with TB with no evidence of complete resolution
• • Patients with severe or chronic infections (e.g. sepsis, abscesses, opportunistic infections, invasive fungal infections), or severe or chronic infection, without sufficient documentation of complete resolution following treatment
• • Patients with recent exposure to persons with active TB, or a positive test result for latent TB at Screening. A patient who has received at least the first 30 days or recommended period of country-specific TB prophylactic therapy and intends to complete the entire course of therapy may be enrolled. Recommended methods to screening latent TB are interferon-γ release assay \[IGRA\] test, with a chest X-ray, however, other methods could be used according to local guideline.
• • Patients with moderate or severe heart failure (New York Heart Association NYHA class III/IV).
• • Patients for whom the treatment with Tumor necrosis factor-alpha (TNF-α) blockers is concerning due to a history of malignancy within the previous five years prior to enrollment or a history of herpes zoster within one month prior to enrollment, may be excluded at the investigator's discretion.
• • Patients who meet any of the contraindications to the administration of infliximab