Clinical trial NCT02326155: To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
Official title: An Observational, Prospective Cohort Study to Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn's Disease
Ulcerative Colitis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2014-12-25
Enrollment: 470
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of at least 500 male and female patients with active CD, fistulizing active CD, and UC

Brief summary: An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™ in patients with Crohn's disease (CD) or Ulcerative Colitis (UC)

Detailed description: This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of Remsima™ in patients with IBD, who have active Crohn's disease (CD), fistulizing Crohn's disease (CD), or Ulcerative Colitis (UC). Patients will be included in this registry who are receiving treatment with 5 mg/kg of Remsima™ by IV infusion at weeks 0, 2, 6, and every 8 weeks thereafter in accordance with the product label. If a patient has been treated with infliximab prior to enrollment, his or her dosing schedule will be continued appropriately. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Eligibility criteria: Inclusion Criteria:

* Adult patients with moderate to severe active CD
* Children and adolescent patients, aged 6 to 17 years old with severe active CD
* Adult patients with fistulizing active CD
* Adult patients with moderate to severe active UC
* Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of Remsima™.
* Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records.

Exclusion Criteria:

* Patients with a history of hypersensitivity to infliximab
* Patients with a current or past history of chronic infection
* Patients with current diagnosis of Tuberculosis (TB) or severe or chronic infections (e.g. sepsis, abscesses, opportunistic infections, invasive fungal infections), or previously diagnosed with TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
* Recent exposure to persons with active TB, or a positive test result for latent TB (determined by a positive interferon-γ release assay \[IGRA\] test, with a negative chest X-ray) at Screening
* Patients with moderate or severe heart failure (NYHA class III/IV).

Primary outcomes:
measure: Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI)
timeFrame: Up to 5 years for each patient
Secondary outcomes:
measure: Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100
timeFrame: Every 6 months (months 6 -60)
measure: Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30
timeFrame: Every 6 months (months 6 -42)
measure: Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline
timeFrame: Every 6 months (months 6 -48)
measure: Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1.
timeFrame: Every 6 months (months 6 - 60)
measure: Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score
timeFrame: Every 6 months (months 6 - 18)
Other outcomes:
Locations:
Study officials:
affiliation: Ostrava, Morvskoslezsky kraj, Czech Republic, 708 52
name: Pavel Svoboda
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.