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Post Marketing Surveillance of Remicade

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00724529
First received: July 25, 2008
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to understand the safety and effectiveness of infliximab when used in clinical practice. This is a post-marketing surveillance study.


Condition Intervention Phase
Crohn's Disease
Ankylosing Spondylitis
Biological: Infliximab
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice [ Time Frame: The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the efficacy of Remicade Injection (Infliximab) when used in clinical practice [ Time Frame: The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis. ] [ Designated as safety issue: No ]

Enrollment: 938
Study Start Date: June 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Serious Active Crohns Disease
Patients with severe active Crohns Disease who do not show any response to treatment with corticosteroids or immunosuppressive agents, and have no drug tolerance or contraindications to such treatments.
Biological: Infliximab
Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.
Other Names:
  • SCH 215596
  • Remicade
Fistula-Type Active Crohns Disease
Patients with fistula-type Crohns Disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
Biological: Infliximab
Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.
Other Names:
  • SCH 215596
  • Remicade
Ankylosing Spondylitis
Patients with Ankylosing Spondylitis who do not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation.
Biological: Infliximab
Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.
Other Names:
  • SCH 215596
  • Remicade

Detailed Description:

The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Remicade approval.

  Eligibility

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

The population of subjects will mainly be taken from the digestive or rheumatoid departments of internal medicine in university or general hospitals, where patients with Crohn's Disease and Ankylosing Spondylitis are generally treated. The period of surveillance is from 23 AUG 2005 to 22 AUG 2011.

Criteria

Inclusion Criteria:

  • Severe active Crohn's disease: the patients with severe active Crohn's disease who do not show any response to the treatment with corticosteroid or immunosuppressive agents, have no drug tolerance, or are contraindicated to such treatments.
  • Fistula-type active Crohn's disease: the patients with fistula-type active Crohn's disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
  • Ankylosing spondylitis: the patients with ankylosing spondylitis who do not show adequate response to general treatments, and with increased serological indices related to severe axial symptoms and inflammation.

Exclusion Criteria:

  • None
  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: NCT00724529

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00724529     History of Changes
Other Study ID Numbers: CR100771, REMICADECRD4015
Study First Received: July 25, 2008
Last Updated: January 21, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Janssen Korea, Ltd., Korea:
Crohn's Disease
Ankylosing Spondylitis

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intestinal Diseases
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
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

ClinicalTrials.gov processed this record on November 25, 2014