Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01318993
Status:
TERMINATED
Last Update Posted:
2017-09-14
First Post:
2011-03-03
Brief Title:
Open-Label Extension Study of GSK1605786A
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohns Disease
Status:
TERMINATED
Status Verified Date:
2017-07
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-3
Brief Summary:
An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohns disease Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 maintenance study of GSK1605786A due to worsening of Crohns disease requiring a treatment change may be eligible to participate The primary objective is to evaluate the safety of GSK1605786A as assessed by recording of adverse events clinical laboratory parameters vital signs and electrocardiogram Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire IBDQ SF-36v2 EQ-5D Work and Productivity Activity Impairment-Crohns Disease WPAI-CD and receipt of disability
Detailed Description:
This is a multi-centre open-label extension study to assess the long-term safety tolerability and effectiveness of GSK1605786A in subjects with Crohns disease Subjects will enter the study via one of three routes
1 completion of the placebo-controlled induction study CCX114151 without achieving clinical response CDAI decrease of at least 100 points or clinical remission CDAI score less than 150 at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor
2 completion of maintenance study CCX114157 at Week 52
3 withdrawal from maintenance study CCX114157 due to worsening of Crohns disease and requiring a treatment change
The primary objective is to evaluate the safety of GSK1605786A as assessed by recording of adverse events clinical laboratory parameters vital signs and electrocardiogram Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire IBDQ SF-36v2 EQ-5D Work and Productivity Activity Impairment-Crohns Disease WPAI-CD and disability
It is estimated that approximately 800 subjects will be enrolled in total All subjects will enter the study at baseline Week 0 and commence oral treatment with GSK1605786A 500 mg twice daily
The study will be conducted for 108 weeks Once the results of the induction study CCX114151 are known the risk-to-benefit ratio will be re-assessed and the study duration may be amended
Study assessments for Crohns disease will be performed every 12 weeks through Week 108 At week 12 the investigator will make a determination of whether the subject is receiving clinical benefit and subjects who are not receiving clinical benefit must be withdrawn More frequent blood draws are required for liver function testing only every 2 weeks for the first 12 weeks then every 4 weeks up to Week 52 and every 12 weeks after Week 60 for the duration of the study
1 completion of the placebo-controlled induction study CCX114151 without achieving clinical response CDAI decrease of at least 100 points or clinical remission CDAI score less than 150 at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor
2 completion of maintenance study CCX114157 at Week 52
3 withdrawal from maintenance study CCX114157 due to worsening of Crohns disease and requiring a treatment change
The primary objective is to evaluate the safety of GSK1605786A as assessed by recording of adverse events clinical laboratory parameters vital signs and electrocardiogram Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire IBDQ SF-36v2 EQ-5D Work and Productivity Activity Impairment-Crohns Disease WPAI-CD and disability
It is estimated that approximately 800 subjects will be enrolled in total All subjects will enter the study at baseline Week 0 and commence oral treatment with GSK1605786A 500 mg twice daily
The study will be conducted for 108 weeks Once the results of the induction study CCX114151 are known the risk-to-benefit ratio will be re-assessed and the study duration may be amended
Study assessments for Crohns disease will be performed every 12 weeks through Week 108 At week 12 the investigator will make a determination of whether the subject is receiving clinical benefit and subjects who are not receiving clinical benefit must be withdrawn More frequent blood draws are required for liver function testing only every 2 weeks for the first 12 weeks then every 4 weeks up to Week 52 and every 12 weeks after Week 60 for the duration of the study
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 |
|---|---|---|---|
| 2010-022384-35 | EUDRACT_NUMBER | None | None |