Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445432
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2007-03-07
Brief Title:
A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohns Disease
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multi-Center Randomized Double-blind Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohns Disease
Status:
COMPLETED
Status Verified Date:
2012-02
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:
To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohns disease
Detailed Description:
This was a Phase 23 multicenter randomized double-blind DB placebo-controlled two-arm efficacy safety and pharmacokinetic study designed to demonstrate the effectiveness of adalimumab in Japanese patients with moderate to severe Crohns Disease CD
All participants who had completed Study M04-729 NCT00445939 the lead-in adalimumab induction therapy study were eligible for this study Participants who rolled over into this study received either DB treatment adalimumab or placebo or open-label OL treatment with adalimumab
Crohns Disease Activity Index CDAI was used to determine participants who were responders and participants who were in clinical remission CDAI documents number of soft stools abdominal pain general well-being presence of 6 signs arthritisarthralgia iritisuveitis erythema nodosumpyoderma gangrenosumaphthous stomatitis fissure abscess anal fistula other cutaneous fistula fever over 100 degrees taking medication for diarrhea abdominal mass hematocrit and weight loss during a 1-week assessment period It yields a total score 0 and without upper limit Baseline scores in the study ranged from 221 to 448 Low scoreless severe CD activity Decrease in score indicates improvement
Clinical remission is a CDAI score 150
Clinical response-70 CR-70 decrease in CDAI 70 points from lead-in study Baseline score
Clinical response-100 CR-100 decrease in CDAI 100 points from lead-in study Baseline score
Participants who had CR-70 response at Week 4 of the induction study were randomized into 1 of 2 treatment groups double-blind adalimumab 40 mg every other week or adalimumab placebo every other week using 2 stratification factors - CDAI category CDAI less than 150 and CDAI 150 or higher and presenceabsence of fistula at Week 0 of this study The double-blind treatment was to last from Week 0 to Week 52 Any time at or after Week 4 of this study if a participants disease flared defined as a recurrence of very active disease specifically an increase in CDAI when compared to Week 0 in this study of 70 points and a CDAI above 220 during the double-blind treatment period the participant was allowed to move to OL treatment At Week 52 all participants still receiving DB treatment were to be moved to open-label treatment and could continue in the study until adalimumab is approved for commercial use in Japan
Participants who did not respond by Week 4 in the induction study and participants who had disease flare during DB treatment of this study entered OL treatment and received adalimumab 40 mg every other week At or after Week 4 of this study if a participant in the open-label treatment group had a disease flare or if the participant was still not responding to treatment the participant was allowed to dose escalate to adalimumab 80 mg every other week Participants who entered open-label treatment were to be allowed to continue on open-label adalimumab until adalimumab is approved for commercial use in Japan
The study is complete Results of this study are reported for endpoints at Week 52 end of the DB treatment period for subjects who received DB treatment adalimumab or placebo or OL adalimumab treatment and for endpoints at Week 148 for all subjects who received at least one dose of adalimumab in this study
All participants who had completed Study M04-729 NCT00445939 the lead-in adalimumab induction therapy study were eligible for this study Participants who rolled over into this study received either DB treatment adalimumab or placebo or open-label OL treatment with adalimumab
Crohns Disease Activity Index CDAI was used to determine participants who were responders and participants who were in clinical remission CDAI documents number of soft stools abdominal pain general well-being presence of 6 signs arthritisarthralgia iritisuveitis erythema nodosumpyoderma gangrenosumaphthous stomatitis fissure abscess anal fistula other cutaneous fistula fever over 100 degrees taking medication for diarrhea abdominal mass hematocrit and weight loss during a 1-week assessment period It yields a total score 0 and without upper limit Baseline scores in the study ranged from 221 to 448 Low scoreless severe CD activity Decrease in score indicates improvement
Clinical remission is a CDAI score 150
Clinical response-70 CR-70 decrease in CDAI 70 points from lead-in study Baseline score
Clinical response-100 CR-100 decrease in CDAI 100 points from lead-in study Baseline score
Participants who had CR-70 response at Week 4 of the induction study were randomized into 1 of 2 treatment groups double-blind adalimumab 40 mg every other week or adalimumab placebo every other week using 2 stratification factors - CDAI category CDAI less than 150 and CDAI 150 or higher and presenceabsence of fistula at Week 0 of this study The double-blind treatment was to last from Week 0 to Week 52 Any time at or after Week 4 of this study if a participants disease flared defined as a recurrence of very active disease specifically an increase in CDAI when compared to Week 0 in this study of 70 points and a CDAI above 220 during the double-blind treatment period the participant was allowed to move to OL treatment At Week 52 all participants still receiving DB treatment were to be moved to open-label treatment and could continue in the study until adalimumab is approved for commercial use in Japan
Participants who did not respond by Week 4 in the induction study and participants who had disease flare during DB treatment of this study entered OL treatment and received adalimumab 40 mg every other week At or after Week 4 of this study if a participant in the open-label treatment group had a disease flare or if the participant was still not responding to treatment the participant was allowed to dose escalate to adalimumab 80 mg every other week Participants who entered open-label treatment were to be allowed to continue on open-label adalimumab until adalimumab is approved for commercial use in Japan
The study is complete Results of this study are reported for endpoints at Week 52 end of the DB treatment period for subjects who received DB treatment adalimumab or placebo or OL adalimumab treatment and for endpoints at Week 148 for all subjects who received at least one dose of adalimumab in this 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