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Arthritis, RheumatoidNCT00261976

A Long-term Safety Study of Infliximab (Remicade)

An observational study of Arthritis, Rheumatoid and Crohn Disease, run by Centocor, Inc. at 205 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study evaluating the long-term safety of infliximab (Remicade) Read more about this study

Who is it for?
Any age
Conditions the study is for
Arthritis, Rheumatoid, Crohn Disease, Psoriasis
What is being tested?
Infliximab (Remicade)
How many people
2,971 participants
Where
205 sitesin 19 countries
Study dates
Feb 2002to Mar 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

205 sites in 19 countries.

205 sites in 19 countries

United States100 sites

  • Study site

    Akron, Ohio

  • Study site

    Alpharetta, Georgia

  • Study site

    Anaheim, California

  • Study site

    Andover, Massachusetts

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Aventura, Florida

  • Study site

    Baltimore, Maryland

  • Study site

    Bellevue, Washington

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Burlington, Vermont

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroti, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    East Lansing, Michigan

  • Study site

    Edina, Minnesota

  • Study site

    Evanston, Illinois

  • Study site

    Fresno, California

  • Study site

    Fridley, Minnesota

  • Study site

    Goodlettsville, Tennessee

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greenbelt, Maryland

  • Study site

    Gurnee, Illinois

  • Study site

    Hamden, Connecticut

  • Study site

    Hartford, Connecticut

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Iowa City, Iowa

  • Study site

    Irvine, California

  • Study site

    Jackson, Mississippi

  • Study site

    Kirkland, Washington

  • Study site

    Lake Oswego, Oregon

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Largo, Florida

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Madera, California

  • Study site

    Manhasset, New York

  • Study site

    Marietta, Georgia

  • Study site

    Maywood, Illinois

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Montgomery, Alabama

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New York, New York

  • Study site

    Normal, Illinois

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Charleston, South Carolina

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Orlando, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Palm Harbor, Florida

  • Study site

    Paradise Valley, Arizona

  • Study site

    Pasadena, California

  • Study site

    Philadelphia Pennsylvan, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Maine

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Rancho Mirage, California

  • Study site

    Reno, Nevada

  • Study site

    Rochester, New York

  • Study site

    Rockford, Illinois

  • Study site

    Salem, Virginia

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Monica, California

  • Study site

    Sarasota, Florida

  • Study site

    Seattle, Washington

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Tampa, Florida

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Waterbury, Connecticut

  • Study site

    West Reading, Pennsylvania

  • Study site

    Wheaton, Maryland

  • Study site

    Wichita, Kansas

  • Study site

    Willow Grove, Pennsylvania

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worcester, Massachusetts

Other trials in United States

Canada26 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    Halifax

  • Study site

    Hamilton, Ontario

  • Study site

    Hamilton Ontario

  • Study site

    Kitchener, Ontario

  • Study site

    London, Ontario

  • Study site

    Markham, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    Montreal

  • Study site

    Newmarket, Ontario

  • Study site

    North Bay, Ontario

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Richmond, British Columbia

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Saskatoon

  • Study site

    Sherbrooke, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Ste-Foy, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Waterloo, Ontario

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Germany13 sites

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Erlangen

  • Study site

    Frankfurt

  • Study site

    Hamburg

  • Study site

    Leipzig

  • Study site

    Mainz

  • Study site

    Münster

  • Study site

    Oldenburg

  • Study site

    Würzburg

  • Study site

    Wÿrzburg

Other trials in Germany

United Kingdom11 sites

  • Study site

    Bath

  • Study site

    Birmingham

  • Study site

    Cambridge

  • Study site

    Cannock

  • Study site

    Leeds

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Newcastle upon Tyne

  • Study site

    Norwich

  • Study site

    Oxford

Other trials in United Kingdom

Belgium7 sites

  • Study site

    Brussels

  • Study site

    Diepenbeek

  • Study site

    Edegem

  • Study site

    Genk

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

France7 sites

  • Study site

    Créteil

  • Study site

    Montpellier

  • Study site

    Nantes

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Pierre-Bénite

  • Study site

    Poitiers

Other trials in France

Poland6 sites

  • Study site

    Bialystok

  • Study site

    Lublin

  • Study site

    Szczecin

  • Study site

    Warsaw

  • Study site

    Włoszczowa

  • Study site

    Wroclaw

Other trials in Poland

Argentina5 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Cp

  • Study site

    Rosario

  • Study site

    San Miguel de Tucumán

Other trials in Argentina

Denmark5 sites

  • Study site

    Aarhus

  • Study site

    Hellerup

  • Study site

    Hvidovre

  • Study site

    København NV

  • Study site

    Odense

Other trials in Denmark

Spain5 sites

  • Study site

    Barcelona

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Federal

  • Study site

    Madrid

Other trials in Spain

Finland4 sites

  • Study site

    Helsinki

  • Study site

    Hus

  • Study site

    Jyväskylä

  • Study site

    Pikonlinna

Other trials in Finland

Netherlands4 sites

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Maastricht

  • Study site

    Rotterdam

  • Study site

    Utrecht

Other trials in Netherlands

Austria3 sites

  • Study site

    Graz

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

Hungary2 sites

  • Study site

    Budapest

  • Study site

    Debrecen

Other trials in Hungary

Israel2 sites

  • Study site

    Haifa

  • Study site

    Tel Aviv

Other trials in Israel

Switzerland2 sites

  • Study site

    Geneva

  • Study site

    Zurich

Other trials in Switzerland

Ireland1 site

  • Study site

    Dublin

Other trials in Ireland

Norway1 site

  • Study site

    Oslo

Other trials in Norway

Sweden1 site

  • Study site

    Gothenburg

Other trials in Sweden

About this study

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

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

Read the 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.

Being tested
Infliximab (Remicade)
Keywords
Rheumatoid arthritis, Crohn's disease, Psoriasis
Medical subject headings
Arthritis, Rheumatoid, Crohn Disease, Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infliximab (Remicade)Drug

    This is an non-interventional study. Participants took the study product as part of their medical routine.

Study groups in NCT00261976
Study groupRoleWhat they receive
Patients in infliximab clinical studiesAll patients enrolled in selected Centocor sponsored infliximab clinical studies.
Receives: Drug: Infliximab (Remicade)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with each of the following long-term safety events

    Number of patients with each of the following long-term safety events: serious infections, new malignancies, new autoimmune diseases, death, or delayed hypersensitivity (serum sickness-like) reactions.

    Measured: Five years

Secondary outcomes (2)

  1. Number of patients with malignancies by malignancy type

    Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies).

    Measured: Five years

  2. Number of patients with serious infections by type of infection

    Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2005 (estimated)
  2. Study startFeb 2002
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,971 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00261976
Sponsor's protocol ID
CR004780
Other IDs
C0168T45
Status last verified
Mar 2014
First submitted
2 Dec 2005
Last updated
18 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Rheumatoid and Crohn Disease, run by Centocor, Inc. at 205 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, Canada, Germany, United Kingdom, Belgium and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with each of the following long-term safety events (time frame: Five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00261976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.

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