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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational, Prospective Cohort Study to Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

Conditions
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Crohn's Disease, Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remsima™<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Including Hepatitis B virus (HBV) reactivation, congestive heart failure, opportunistic infections (excluding tuberculosis), serious infections including sepsis (excluding opportunistic infections and tuberculosis), tuberculosis (TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, lymphoma (not hepatosplenic T cell lymphoma), hepatobiliary events, hepatosplenic T cell lymphoma, intestinal or perianal abscess (in Crohn's disease), serious infusion reactions during a re-induction regimen following disease flare, sarcoidosis/sarcoid-like reactions, paediatric malignancy, leukaemia, malignancy (excluding lymphoma), colon carcinoma/dysplasia (in Ulcerative Colitis), skin cancer, pregnancy exposure, bowel stenosis/stricture/obstruction (in Crohn's disease) and infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction. | Up to 5 years for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | A patient is considered as achieving clinical response according to CDAI-70 (or CDAI-100) if the patient has a reduction on CDAI score of 70 (or 100) points or more from the baseline value. | Every 6 months (months 6 -60) | 
| 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 | A patient is considered as achieving clinical response according to PCDAI if the patient has a PCDAI score less than or equal to 30 points and a reduction on PCDAI score of 15 points or more from the baseline value. | Every 6 months (months 6 -42) | 
| 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 | A patient is considered as achieving clinical response according to the number of draining fistulas if the patient has a reduction on the number of draining fistulas from the baseline value (over a period of ≥ 4 weeks) ≥ 50%. | Every 6 months (months 6 -48) | 
| 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. | A patient is considered as achieving clinical response according to total Mayo score if the patient has a reduction from baseline in total mayo score at least 3 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. A patient is considered as achieving clinical response according to partial Mayo score if the patient has a reduction from baseline in partial mayo score at least 2 points, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. | Every 6 months (months 6 - 60) | 
| Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score | A patient is considered as achieving clinical response according to PUCAI if the patient has a reduction on PUCAI score of 20 points or more from the baseline value. | Every 6 months (months 6 - 18) |