Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409617
Status:
COMPLETED
Last Update Posted:
2011-10-10
First Post:
2006-12-08
Brief Title:
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohns Disease
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multi-Center Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohns Disease
Status:
COMPLETED
Status Verified Date:
2011-10
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:
The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohns Disease CD and to measure the effects of treatment on patient general well-being health-related quality of life QoL fistula healing CD-related extra-intestinal manifestations work performance and overall activity
Detailed Description:
This is an open-label multi-center study designed to evaluate the safety and efficacy of adalimumab on inducing and maintaining clinical remission in subjects with moderate to severe Crohns Disease
Approximately 1000 subjects with a diagnosis of moderate to severe Crohns Disease Harvey Bradshaw Index score 7 will be enrolled at approximately 200 sites within Europe Enrollment will be dependent on meeting all screening criteria
Study medication will be administered by subcutaneous injection At Baseline Week 0 all subjects will receive a dose of 160 mg adalimumab At Week 2 all subjects will receive a dose of 80 mg adalimumab Starting at Week 4 all subjects will begin receiving injections of adalimumab 40 mg every other week and will continue every other week dosing through Week 20 except in the case of disease flare or non-response
Starting at Week 12 subjects who experience a disease flare flare is defined by an increase in the Harvey Bradshaw Index 3 and a total Index score of 7 when compared to Week 4 or are not responding to adalimumab treatment non-response is defined as a decrease in the Harvey Bradshaw Index by fewer than 3 points compared to Baseline will be permitted to increase study therapy to adalimumab 40 mg every week
If the subject continues to demonstrate a lack of improvement on every week adalimumab therapy they may be withdrawn from the study
Prior to Week 8 subjects will not be allowed to increase or decrease Crohns specific concomitant medications except in the event of concomitant Crohns treatment-related toxicities assessed as moderate to severe Changes in concomitant medications atafter Week 8 will be at the Investigators discretion
Subjects will be evaluated for safety and efficacy at Baseline Week 0 Weeks 2 4 8 12 and 20 and at unscheduled visits Efficacy evaluations include HBI Short Inflammatory Bowel Disease Questionnaire SIBDQ Work Productivity Activity Index WPAI questionnaire fistula counts health care resource utilization HCRU and evaluation of CD-related extra-intestinal manifestations EIMs Safety assessments include vital signs physical examination general laboratory analyses urinalysis and monitoring of adverse events AEs
Approximately 1000 subjects with a diagnosis of moderate to severe Crohns Disease Harvey Bradshaw Index score 7 will be enrolled at approximately 200 sites within Europe Enrollment will be dependent on meeting all screening criteria
Study medication will be administered by subcutaneous injection At Baseline Week 0 all subjects will receive a dose of 160 mg adalimumab At Week 2 all subjects will receive a dose of 80 mg adalimumab Starting at Week 4 all subjects will begin receiving injections of adalimumab 40 mg every other week and will continue every other week dosing through Week 20 except in the case of disease flare or non-response
Starting at Week 12 subjects who experience a disease flare flare is defined by an increase in the Harvey Bradshaw Index 3 and a total Index score of 7 when compared to Week 4 or are not responding to adalimumab treatment non-response is defined as a decrease in the Harvey Bradshaw Index by fewer than 3 points compared to Baseline will be permitted to increase study therapy to adalimumab 40 mg every week
If the subject continues to demonstrate a lack of improvement on every week adalimumab therapy they may be withdrawn from the study
Prior to Week 8 subjects will not be allowed to increase or decrease Crohns specific concomitant medications except in the event of concomitant Crohns treatment-related toxicities assessed as moderate to severe Changes in concomitant medications atafter Week 8 will be at the Investigators discretion
Subjects will be evaluated for safety and efficacy at Baseline Week 0 Weeks 2 4 8 12 and 20 and at unscheduled visits Efficacy evaluations include HBI Short Inflammatory Bowel Disease Questionnaire SIBDQ Work Productivity Activity Index WPAI questionnaire fistula counts health care resource utilization HCRU and evaluation of CD-related extra-intestinal manifestations EIMs Safety assessments include vital signs physical examination general laboratory analyses urinalysis and monitoring of adverse events AEs
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 |
|---|---|---|---|
| EudraCT2006-002078-23 | None | None | None |