Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055497
Status:
COMPLETED
Last Update Posted:
2011-04-11
First Post:
2003-03-03
Brief Title:
Remission in Subjects With Crohns Disease 1 Year Phase
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohns Disease
Status:
COMPLETED
Status Verified Date:
2011-04
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:
CLASSICII
Brief Summary:
The objectives were 1 To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohns disease who participated in NCT00055523 2 To delineate the safety of adalimumab when administered to participants with Crohns disease up to 56 weeks
Detailed Description:
Study NCT00055497 was designed to evaluate the efficacy and safety of adalimumab in the maintenance of clinical remission in patients with Crohns disease CD The study consisted of 2 phases 1 the first year phase lasting until Week 56 and consisting of a randomized double-blind DB placebo-controlled portion NCT00055497 and of a concomitant open label OL portion and 2 a long-term extension phase NCT01070303 that lasted 264 additional weeks Week 56 to Week 320
Potential participants were screened at the time of enrollment in the lead-in induction therapy study NCT00055523 Participants who completed the lead-in study NCT00055523 were eligible to participate in the rollover study NCT00055497
In Study NCT00055497 all participants received 40 mg of adalimumab subcutaneously SC at Baseline Week 0 and Week 2 of Study NCT00055497 Baseline of Study NCT00055497 is synonymous with NCT00055523 Week 4 At Week 4 of Study NCT00055497 participants were randomized based on their clinical remission status at Baseline and Week 4 of Study NCT00055497 Participants who demonstrated clinical remission defined as a Crohns Disease Activity Index CDAI score 150 points at Baseline of Study NCT00055497 and who remained in clinical remission at Week 4 of Study NCT00055497 those participants constituted the randomized analysis set were randomized to receive 1 of 3 blinded treatments adalimumab 40 mg every other week eow adalimumab 40 mg every week ew or placebo Participants who did not demonstrate clinical remission at Baseline of Study NCT00055497 or who were no longer in clinical remission at Week 4 of Study NCT00055497 were assigned to receive OL adalimumab 40 mg eow those participants constituted the OL analysis set At any time during Study NCT00055497 participants receiving OL adalimumab 40 mg SC eow who developed a flare or were non-responders during OL treatment could have had hisher dose increased to 40 mg SC weekly Participants who were documented as having completed Week 56 are counted in the study completion total
After 1 year Week 56 participants who met eligibility criteria for the long-term extension phase NCT01070303 were switched to OL adalimumab 40 mg subcutaneous SC eow and participants previously in the OL treatment group of Study NCT00055497 continued on their previous OL adalimumab dose adalimumab 40 mg SC eow or every week
Potential participants were screened at the time of enrollment in the lead-in induction therapy study NCT00055523 Participants who completed the lead-in study NCT00055523 were eligible to participate in the rollover study NCT00055497
In Study NCT00055497 all participants received 40 mg of adalimumab subcutaneously SC at Baseline Week 0 and Week 2 of Study NCT00055497 Baseline of Study NCT00055497 is synonymous with NCT00055523 Week 4 At Week 4 of Study NCT00055497 participants were randomized based on their clinical remission status at Baseline and Week 4 of Study NCT00055497 Participants who demonstrated clinical remission defined as a Crohns Disease Activity Index CDAI score 150 points at Baseline of Study NCT00055497 and who remained in clinical remission at Week 4 of Study NCT00055497 those participants constituted the randomized analysis set were randomized to receive 1 of 3 blinded treatments adalimumab 40 mg every other week eow adalimumab 40 mg every week ew or placebo Participants who did not demonstrate clinical remission at Baseline of Study NCT00055497 or who were no longer in clinical remission at Week 4 of Study NCT00055497 were assigned to receive OL adalimumab 40 mg eow those participants constituted the OL analysis set At any time during Study NCT00055497 participants receiving OL adalimumab 40 mg SC eow who developed a flare or were non-responders during OL treatment could have had hisher dose increased to 40 mg SC weekly Participants who were documented as having completed Week 56 are counted in the study completion total
After 1 year Week 56 participants who met eligibility criteria for the long-term extension phase NCT01070303 were switched to OL adalimumab 40 mg subcutaneous SC eow and participants previously in the OL treatment group of Study NCT00055497 continued on their previous OL adalimumab dose adalimumab 40 mg SC eow or every week
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