Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-29 @ 10:30 AM
Study NCT ID:
NCT00818168
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2009-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
Remicade Safety Line (Ankylosing Spondylitis)
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).
Detailed Description:
This study population was chosen from a non-probability sample.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: