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| ID | Type | Description | Link |
|---|---|---|---|
| REMICADECRD4015 | Other Identifier | Janssen Korea, Ltd., Korea |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| D007410 | Intestinal Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |