Clinical trial NCT00207688: A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
Official title: A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Infliximab
Remicade
Safety
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Janssen Biologics BV
First posted: 2005-09-21
Enrollment: 505
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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 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

Primary outcomes:
measure: Number of patients with adverse events as a measure of safety
timeFrame: 5 years
Secondary outcomes:
measure: Number of patients with malignancies by malignancy type
timeFrame: 5 years
measure: Number of patients with serious infections by type of infection
timeFrame: 5 years
measure: Number of patients with surgical procedures (including colectomy) for the treatment of ulcerative colitis
timeFrame: 5 years
measure: Number of patients with hospitalizations for the treatment of ulcerative colitis
timeFrame: 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Laurel
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Plymouth
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Egg Harbor Township
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Beaver Falls
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Federal
country: Argentina
city: Bedford
country: Australia
city: Box Hill
country: Australia
city: Garran
country: Australia
city: Herston
country: Australia
city: Kogarah
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: South Brisbane
country: Australia
city: Innsbruck
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brussel
country: Belgium
city: Imeldalaan 9
country: Belgium
city: Leuven
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver N/A
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal N/A
country: Canada
state: Quebec
city: Edmonton
country: Canada
city: Halifax
country: Canada
city: Quebec
country: Canada
city: Pardubice
country: Czechia
city: Praha 10
country: Czechia
city: Aalborg
country: Denmark
city: Aarhus C.
country: Denmark
city: Hvidovre N/A
country: Denmark
city: København
country: Denmark
city: Lille
country: France
city: Nancy Cedex
country: France
city: Paris
country: France
city: Strasbourg Cedex
country: France
city: Toulouse
country: France
city: Berlin N/A
country: Germany
city: München
country: Germany
city: Stade
country: Germany
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Rehovot
country: Israel
city: Tel-Aviv
country: Israel
city: Eindhoven
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Zurich
country: Switzerland
city: Cardiff
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28.