A Long-term Safety Study of Infliximab (Remicade)

This study has been completed.
Sponsor:
Collaborator:
Centocor BV
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00261976
First received: December 2, 2005
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Arthritis, Rheumatoid
Crohn Disease
Psoriasis
Drug: Infliximab (Remicade)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Number of patients with each of the following long-term safety events [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of patients with malignancies by malignancy type [ Time Frame: Five years ] [ Designated as safety issue: No ]
    Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies).

  • Number of patients with serious infections by type of infection [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Enrollment: 2971
Study Start Date: February 2002
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients in infliximab clinical studies
All patients enrolled in selected Centocor sponsored infliximab clinical studies.
Drug: Infliximab (Remicade)
This is an non-interventional study. Participants took the study product as part of their medical routine.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261976

  Show 212 Study Locations
Sponsors and Collaborators
Centocor, Inc.
Centocor BV
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00261976     History of Changes
Other Study ID Numbers: CR004780, C0168T45
Study First Received: December 2, 2005
Last Updated: March 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Rheumatoid arthritis
Crohn's disease
Psoriasis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Crohn Disease
Psoriasis
Autoimmune Diseases
Connective Tissue Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on October 21, 2014