A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

Detailed Description
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This is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(Remicade) clinical studies in ulcerative colitis that require long-term safety follow-up. All patients who received at least one dose of study drug (infliximab or placebo) in the primary studies (C0168T37 ,C0168T46, C0168T72) are eligible to participate in this long-term safety follow-up study (C0168T62). Patients will begin participation in C0168T62 at the time of their last safety visit in the primary study and will be followed for 5 years. No study agent will be administered. Information on deaths, serious infections, new malignancies (including colorectal cancer) and new autoimmune diseases and surgical procedures (including colectomy) and hospitalizations for the treatment of ulcerative colitis will be collected. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab after the end of the primary study. In addition, data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up. All adverse events, including non-serious adverse events, will also be collected.

Official Title
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A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Infliximab 5 mg/kg
* Drug: Infliximab 10 mg/kg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up Patients must have received at least 1 dose of study agent to be eligible for participation in the study Exclusion Criteria: - Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation
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 |
| --- | --- |
| Infliximab 5 mg/kg<br>This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. | Drug: Infliximab 5 mg/kg<br>* Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.<br>|
| Infliximab 10 mg/kg<br>This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. | Drug: Infliximab 10 mg/kg<br>* Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.<br>|
| Placebo<br>This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72. | Drug: Placebo<br>* Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as a measure of safety | Long-term safety will be evaluated by assessment of serious infections,new malignancies (including colorectal cancer), new autoimmune diseases, death, delayed hypersensitivity (serum sickness-like) reactions, or dysplasia of the colon and other non-serious adverse events. Non-serious adverse events will be collected for participants continuing at the beginning of collection of non-serious adverse events. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with malignancies by malignancy type | Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies) | 5 years | 
| Number of patients with serious infections by type of infection |  | 5 years | 
| Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis |  | 5 years | 
| Number of patients with hospitalizations for the treatment of ulcerative colitis |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Infliximab, Remicade, Safety