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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207688
First Posted: September 21, 2005
Last Update Posted: March 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Biologics BV
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis Drug: Infliximab 5 mg/kg Drug: Infliximab 10 mg/kg Drug: Placebo Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Number of patients with adverse events as a measure of safety [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures:
  • Number of patients with malignancies by malignancy type [ Time Frame: 5 years ]
    Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies)

  • Number of patients with serious infections by type of infection [ Time Frame: 5 years ]
  • Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis [ Time Frame: 5 years ]
  • Number of patients with hospitalizations for the treatment of ulcerative colitis [ Time Frame: 5 years ]

Enrollment: 505
Study Start Date: August 2004
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infliximab 5 mg/kg
This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
Drug: Infliximab 5 mg/kg
Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
Infliximab 10 mg/kg
This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
Drug: Infliximab 10 mg/kg
Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.
Placebo
This is an observational study which includes patients from primary studies C0168T37, C0168T46, C0168T72.
Drug: Placebo
Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ulcerative colitis who have participated in infliximab clinical studies and must have received at least 1 dose of study medication to be eligible for participation in C0168T62.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207688


  Show 103 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Janssen Biologics BV
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00207688     History of Changes
Other Study ID Numbers: CR004801
C0168T62 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: March 15, 2016
Last Verified: March 2016

Keywords provided by Janssen Research & Development, LLC:
Ulcerative Colitis
Infliximab
Remicade
Safety

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents