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A Long-term Safety Study of Infliximab (Remicade)

Information source: Centocor, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid; Crohn Disease; Psoriasis

Intervention: Infliximab (Remicade) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Centocor, Inc.

Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.

Summary

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

Clinical Details

Official title: Long-term Safety Follow-up of REMICADE (RESULTS)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of patients with each of the following long-term safety events

Secondary outcome:

Number of patients with malignancies by malignancy type

Number of patients with serious infections by type of infection

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Buenos Aires, Argentina

Cordoba, Argentina

Cp, Argentina

Rosario, Argentina

San Miguel De Tucuman, Argentina

Graz, Austria

Innsbruck, Austria

Wien, Austria

Brussel, Belgium

Bruxelles, Belgium

Diepenbeek, Belgium

Edegem, Belgium

Genk, Belgium

Gent, Belgium

Leuven, Belgium

Liege, Belgium

Halifax, Canada

Hamilton Ontario, Canada

Montreal, Canada

Quebec, Canada

Saskatoon, Canada

Aarhus, Denmark

Hellerup N/A, Denmark

Hvidovre, Denmark

Kobenhavn Nv, Denmark

Odense N/A, Denmark

Helsinki, Finland

Hus, Finland

Jyväskylä N/A, Finland

Pikonlinna, Finland

Créteil, France

Montpellier Cedex 5, France

Nantes Cedex 1, France

Nice Cedex, France

Nice, France

Paris Cedex 10, France

Paris Cedex 14, France

Paris, France

Pierre Benite, France

Poitiers, France

Berlin, Germany

Bochum, Germany

Dresden, Germany

Erlangen, Germany

Frankfurt, Germany

Hamburg, Germany

Köln, Germany

Leipzig, Germany

Mainz, Germany

Muenster, Germany

Oldenburg, Germany

Würzburg, Germany

Wÿrzburg, Germany

Budapest, Hungary

Debrecen, Hungary

Dublin, Ireland

Haifa, Israel

Tel Aviv, Israel

Amsterdam Zuidoost, Netherlands

Maastricht, Netherlands

Rotterdam, Netherlands

Utrecht, Netherlands

Oslo, Norway

Bialystok N/A, Poland

Lublin, Poland

Szczecin, Poland

Warszawa, Poland

Wloszczowa, Poland

Wroclaw, Poland

Barcelona, Spain

Buenos Aires, Spain

Cordoba, Spain

Federal, Spain

Madrid, Spain

Göteborg, Sweden

Geneve N/A, Switzerland

Zurich, Switzerland

Bath, United Kingdom

Birmingham, United Kingdom

Cambridge, United Kingdom

Cannock, United Kingdom

Leeds, United Kingdom

Liverpool, United Kingdom

London, United Kingdom

Manchester, United Kingdom

Newcastle Upon Tyne, United Kingdom

Norwich, United Kingdom

Oxford, United Kingdom

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Montgomery, Alabama, United States

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Paradise Valley, Arizona, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Richmond, British Columbia, Canada

Vancouver N/A, British Columbia, Canada

Vancouver, British Columbia, Canada

Anaheim, California, United States

Fresno, California, United States

Irvine, California, United States

Los Angeles, California, United States

Madera, California, United States

Orange, California, United States

Pasadena, California, United States

Rancho Mirage, California, United States

San Diego, California, United States

Santa Monica, California, United States

Stanford, California, United States

Torrance, California, United States

Denver, Colorado, United States

Hamden, Connecticut, United States

Hartford, Connecticut, United States

New Haven, Connecticut, United States

Waterbury, Connecticut, United States

Aventura, Florida, United States

Largo, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Palm Harbor, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Alpharetta, Georgia, United States

Atlanta, Georgia, United States

Marietta, Georgia, United States

Coeur D'Alene, Idaho, United States

Chicago, Illinois, United States

Evanston, Illinois, United States

Gurnee, Illinois, United States

Maywood, Illinois, United States

Normal, Illinois, United States

Rockford, Illinois, United States

Springfield, Illinois, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Overland Park, Kansas, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Portland, Maine, United States

Winnipeg, Manitoba, Canada

Baltimore, Maryland, United States

Greenbelt, Maryland, United States

Wheaton, Maryland, United States

Andover, Massachusetts, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroti, Michigan, United States

East Lansing, Michigan, United States

Grand Rapids, Michigan, United States

Edina, Minnesota, United States

Fridley, Minnesota, United States

Jackson, Mississippi, United States

Saint Louis, Missouri, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

Reno, Nevada, United States

Moncton, New Brunswick, Canada

Voorhees, New Jersey, United States

Manhasset, New York, United States

New York, New York, United States

Rochester, New York, United States

Saint-John'S, Newfoundland and Labrador, Canada

St. John'S, Newfoundland and Labrador, Canada

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Raleigh, North Carolina, United States

Wilmington, North Carolina, United States

Winston Salem, North Carolina, United States

Halifax, Nova Scotia, Canada

Akron, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Hamilton, Ontario, Canada

Kitchener, Ontario, Canada

London, Ontario, Canada

Markham, Ontario, Canada

Newmarket, Ontario, Canada

North Bay, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Waterloo, Ontario, Canada

Lake Oswego, Oregon, United States

Portland, Oregon, United States

Bethlehem, Pennsylvania, United States

Lancaster, Pennsylvania, United States

Norristown, Pennsylvania, United States

Philadelphia Pennsylvan, Pennsylvania, United States

West Reading, Pennsylvania, United States

Willow Grove, Pennsylvania, United States

Montreal, Quebec, Canada

Sainte-Foy, Quebec, Canada

Sherbrooke, Quebec, Canada

Ste-Foy, Quebec, Canada

North Charleston, South Carolina, United States

Goodlettsville, Tennessee, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Lubbock, Texas, United States

San Antonio, Texas, United States

Burlington, Vermont, United States

Salem, Virginia, United States

Bellevue, Washington, United States

Kirkland, Washington, United States

Seattle, Washington, United States

Spokane, Washington, United States

Milwaukee, Wisconsin, United States

Additional Information

Study results from the long term safety follow-up of REMICADE (RESULTS)

Starting date: February 2002
Last updated: March 15, 2014

Page last updated: August 23, 2015

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