Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358670
Status:
TERMINATED
Last Update Posted:
2017-04-11
First Post:
2006-07-31
Brief Title:
Long-Term Effects of Infliximab in the Treatment of Moderate to Severe Psoriasis Extension of Study P04271 NCT00251641 P04563
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Long-Term Efficacy and Safety Study of Infliximab in the Treatment of Moderate to Severe Plaque-Type Psoriasis
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Infusion reactions during re-induction cycles after a period of no treatment Please see Purpose section
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a long-term randomized multi-center open-label study of infliximab treatment in adults with moderate to severe plaque-type psoriasis This study is the long-term extension of Study P04271 NCT00251641 Study P04271 is a Phase 3b randomized parallel-group multicenter open-label 26-week study comparing the efficacy and safety of infliximab versus methotrexate in the treatment of adult subjects with moderate to severe plaque-type psoriasis The objectives of this study are to assess the efficacy and safety of long-term maintenance therapy versus intermittent therapy with 5 mgkg infliximab in a moderate to severe plaque-type psoriasis population
During an interim safety evaluation of the trial a higher incidence of serious and severe infusion reactions was observed in the intermittent treatment arm consisting of a re-induction cycle maximum of 4 infusions at 0 2 6 and 14 weeks after a period of no treatment compared with the maintenance arm infusions every 8 weeks without an interruption of treatment Consequently the sponsor has terminated the trial The label will be updated to reflect this new information relating to the use of a re-induction regimen with infliximab
During an interim safety evaluation of the trial a higher incidence of serious and severe infusion reactions was observed in the intermittent treatment arm consisting of a re-induction cycle maximum of 4 infusions at 0 2 6 and 14 weeks after a period of no treatment compared with the maintenance arm infusions every 8 weeks without an interruption of treatment Consequently the sponsor has terminated the trial The label will be updated to reflect this new information relating to the use of a re-induction regimen with infliximab
Detailed Description:
None
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 |
|---|---|---|---|
| EUDRACT NUMBER2005-005367-28 | None | None | None |