Clinical trial NCT00261976: A Long-term Safety Study of Infliximab (Remicade)
Official title: Long-term Safety Follow-up of REMICADE (RESULTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Crohn Disease
Psoriasis
Keywords: Rheumatoid arthritis
Crohn's disease
Psoriasis
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Centocor BV
First posted: 2005-12-06
Enrollment: 2971
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: All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies.

Brief summary: This is a study evaluating the long-term safety of infliximab (Remicade)

Detailed description: The purpose of this study is to collect long-term safety information on infliximab (Remicade) from patients who participate in research studies using those drugs. All patients in these studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Additional information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if you received infliximab (Remicade) after the end of the primary study. Study participation in this research study is 5 years after the end of the primary study. Questionnaires will be completed about patient's health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after patients complete participation in the primary study.

Eligibility criteria: Inclusion Criteria:

* All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies that require long-term safety follow-up (ie, primary studies). Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion Criteria:

- Did not previously participate in Centocor sponsored infliximab clinical studies.

Primary outcomes:
measure: Number of patients with each of the following long-term safety events
timeFrame: Five years
Secondary outcomes:
measure: Number of patients with malignancies by malignancy type
timeFrame: Five years
measure: Number of patients with serious infections by type of infection
timeFrame: Five years
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Paradise Valley
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Fresno
country: United States
state: California
city: Irvine
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Madera
country: United States
state: California
city: Orange
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Stanford
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hamden
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Coeur D'Alene
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Normal
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Portland
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Greenbelt
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Andover
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroti
country: United States
state: Michigan
city: East Lansing
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Fridley
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Voorhees
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Philadelphia Pennsylvan
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Willow Grove
country: United States
state: Pennsylvania
city: North Charleston
country: United States
state: South Carolina
city: Goodlettsville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Salem
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Cp
country: Argentina
city: Rosario
country: Argentina
city: San Miguel De Tucuman
country: Argentina
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Wien
country: Austria
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Diepenbeek
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Richmond
country: Canada
state: British Columbia
city: Vancouver N/A
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Moncton
country: Canada
state: New Brunswick
city: Saint-John'S
country: Canada
state: Newfoundland and Labrador
city: St. John'S
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: North Bay
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Halifax
country: Canada
city: Hamilton Ontario
country: Canada
city: Montreal
country: Canada
city: Quebec
country: Canada
city: Saskatoon
country: Canada
city: Aarhus
country: Denmark
city: Hellerup N/A
country: Denmark
city: Hvidovre
country: Denmark
city: Kobenhavn Nv
country: Denmark
city: Odense N/A
country: Denmark
city: Helsinki
country: Finland
city: Hus
country: Finland
city: Jyväskylä N/A
country: Finland
city: Pikonlinna
country: Finland
city: Créteil
country: France
city: Montpellier Cedex 5
country: France
city: Nantes Cedex 1
country: France
city: Nice Cedex
country: France
city: Nice
country: France
city: Paris Cedex 10
country: France
city: Paris Cedex 14
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Poitiers
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dresden
country: Germany
city: Erlangen
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Mainz
country: Germany
city: Muenster
country: Germany
city: Oldenburg
country: Germany
city: Würzburg
country: Germany
city: Wÿrzburg
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Dublin
country: Ireland
city: Haifa
country: Israel
city: Tel Aviv
country: Israel
city: Amsterdam Zuidoost
country: Netherlands
city: Maastricht
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Oslo
country: Norway
city: Bialystok N/A
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Wloszczowa
country: Poland
city: Wroclaw
country: Poland
city: Barcelona
country: Spain
city: Buenos Aires
country: Spain
city: Cordoba
country: Spain
city: Federal
country: Spain
city: Madrid
country: Spain
city: Göteborg
country: Sweden
city: Geneve N/A
country: Switzerland
city: Zurich
country: Switzerland
city: Bath
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cannock
country: United Kingdom
city: Leeds
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Norwich
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: