Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01316939
Status:
TERMINATED
Last Update Posted:
2017-09-07
First Post:
2011-03-03
Brief Title:
GSK1605786A in the Maintenance of Remission in Subjects With Crohns Disease
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A 52 Week Randomised Double-blind Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohns Disease
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due to the lack of efficacy of GSK1605786A in Crohns disease based on the results of Study CCX114151
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIELD-2
Brief Summary:
A randomised double-blind placebo-controlled study to evaluate the efficacy and safety of two doses 500 mg once daily and 500 mg twice daily of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohns disease Efficacy will be assessed by the Crohns Disease Activity Index CDAI score Eligible subjects will have achieved response CDAI decrease of at least 100 points andor remission CDAI less than 150 in a prior GSK sponsored induction study The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52 Safety will be assessed by recording of adverse events clinical laboratory parameters including liver function tests vital signs and electrocardiogram Population pharmacokinetics will evaluate the two doses of GSK1605786A Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire IBDQ SF-36v2 EQ-5D Work Productivity and Activity Impairment - Crohns Disease WPAI-CD and disability
Detailed Description:
This is a multi-centre randomised placebo-controlled double-blind parallel group study in adult subjects with Crohns disease who previously achieved clinical response CDAI decrease of at least 100 points andor remission CDAI less than 150 in a prior Phase III induction study Study CCX114151 or another GSK sponsored induction study Subjects will be randomised to 52 weeks of oral treatment with GSK1605786A 500 mg once daily or 500 mg twice daily or placebo Subjects who are receiving concomitant corticosteroids at entry will undergo dose tapering following a defined schedule Subjects who complete the treatment period may be eligible to enter an open-label extension study Subjects who experience disease worsening and require additional rescue treatment will be withdrawn and may be eligible to enter the open-label study Subjects who do not enter the open-label study must complete a follow-up assessment 4 weeks after completion of treatment Approximately 756 subjects will be enrolled
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 |
|---|---|---|---|
| 2010-022383-12 | EUDRACT_NUMBER | None | None |