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A Long Term Safety Study of Infliximab (Remicade)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Centocor, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centocor BV
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00261976
First received: December 2, 2005
Last updated: March 12, 2009
Last verified: March 2009
History of Changes
  Purpose

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


Condition Phase
Psoriasis
Crohn Disease
Arthritis, Rheumatoid
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Long Term Safety Follow-up of REMICADE (RESULTS)

Resource links provided by NLM:

Drug Information available for: Infliximab
U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Study Start Date: July 2002
Detailed Description:

The purpose of this study is to collect long-term safety information on infliximab (Remicade) from subjects who participate in research studies using those drugs. All subjects 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 completed participation in the primary study.

N/A

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261976

Sponsors and Collaborators
Centocor, Inc.
Centocor BV
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00261976     History of Changes
Other Study ID Numbers: CR004780
Study First Received: December 2, 2005
Last Updated: March 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
psoriasis
Crohn's disease
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Crohn Disease
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013