Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01494857
Status:
UNKNOWN
Last Update Posted:
2012-10-30
First Post:
2011-12-15
Brief Title:
Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
Sponsor:
Clalit Health Services
Organization:
Clalit Health Services
Study Overview
Official Title:
Open-Label Non-Randomized Single Patient Group Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis
Status:
UNKNOWN
Status Verified Date:
2012-10
Last Known Status:
RECRUITING
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:
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab a fully human monoclonal antibody to tumor necrosis factor α TNF- α in patients with ulcerative colitis UC naive to treatment with biologics
Detailed Description:
Ulcerative colitis UC is one of the two primary forms of idiopathic inflammatory bowel disease IBD Recent studies have shown that TNF- α may play a major role in the etiopathogenesis of UC justifying the use of anti-TNF-α therapies Adalimumab is an immunoglobulin G1 that specifically binds to TNF-α and neutralizes its function it also modulates the biological response induced and regulated by TNF-α
Conventional UC therapy quite commonly does not bring satisfactory results therefore interest in new treatment methods has been growing recently Biological therapy is a highly promising prospect since it enables to discontinue the use of glucocorticosteroids and immunosuppressives or their dose reduction shortens the hospitalization period allows to avoid surgical treatment extends the clinical response the remission period and improves the patients quality of life
Thus the present study assesses the clinical response of active ulcerative colitis to adalimumab treatment
Conventional UC therapy quite commonly does not bring satisfactory results therefore interest in new treatment methods has been growing recently Biological therapy is a highly promising prospect since it enables to discontinue the use of glucocorticosteroids and immunosuppressives or their dose reduction shortens the hospitalization period allows to avoid surgical treatment extends the clinical response the remission period and improves the patients quality of life
Thus the present study assesses the clinical response of active ulcerative colitis to adalimumab treatment
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A13-675 | OTHER_GRANT | Abbott | None |