To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

Celltrion Healthcare

Status: Terminated

Conditions: Ulcerative Colitis; Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02326155

CT-P13 4.3

Details and patient eligibility

About

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

Full 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.

Enrollment: 470 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

470 participants in 2 patient groups

Remsima™

Description:

Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.

Switched to Remsima

Description:

Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.