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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Biologics BV
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00207688
First received: September 13, 2005
Last updated: July 14, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of patients with malignancies by malignancy type [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of patients with hospitalizations for the treatment of ulcerative colitis [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 241
Study Start Date: September 2003
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 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.

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Janssen Research & Development, LLC

Additional 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
Study First Received: September 13, 2005
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014