Post Marketing Surveillance of Remicade

NCT00724529 | Completed

• 2 other identifiers: CR100771REMICADECRD4015
• Study Type: observational
• Target: 938
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn's Disease; Ankylosing Spondylitis

Keywords

Crohn's Disease; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice

  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.

Secondary Outcomes (1)

• To evaluate the efficacy of Remicade Injection (Infliximab) when used in clinical practice

  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.

Study Arms (3)

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

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

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

Interventions

Infliximab BIOLOGICAL

Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.

Also known as: SCH 215596, Remicade

Ankylosing Spondylitis; Fistula-Type Active Crohns Disease; Serious Active Crohns Disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Crohn Disease; Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: June 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 23, 2013

Record last verified: 2013-01