Know Cancer

forgot password

Long-term Safety Follow-up of REMICADE (RESULTS)

Phase 4
Not Enrolling
Arthritis, Rheumatoid, Crohn Disease, Psoriasis

Thank you

Trial Information

Long-term Safety Follow-up of REMICADE (RESULTS)

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.

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

Exclusion Criteria:

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Five years

Safety Issue:


Principal Investigator

Centocor, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Centocor, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2002

Completion Date:

March 2012

Related Keywords:

  • Arthritis, Rheumatoid
  • Crohn Disease
  • Psoriasis
  • Rheumatoid arthritis
  • Crohn's disease
  • Psoriasis
  • Arthritis
  • Arthritis, Rheumatoid
  • Crohn Disease
  • Psoriasis



Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Scarborough, Maine  04074
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
South Burlington, Vermont  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma  
Las Vegas, Nevada  89109
Jackson, Mississippi  
Coeur D'alene, Idaho  83814