Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408629
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2006-12-05
Brief Title:
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
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:
None
Brief Summary:
This was a Phase 3 multicenter randomized double-blind placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor TNF monoclonal antibody adalimumab ADA in patients with moderately to severely active ulcerative colitis UC
Detailed Description:
This was a Phase 3 multicenter randomized double-blind placebo-controlled trial designed to evaluate the efficacy and safety of adalimumab ADA in patients with moderately to severely active ulcerative colitis UC
The duration of the study was up to 65 weeks including a Screening Period of up to 3 weeks a double-blind DB placebo-controlled treatment period of up to 52 weeks and a 70 day follow-up phone call for participants who prematurely discontinued or who did not enroll in the extension study NCT 00573794 M10-223
Adult participants with moderate to severe UC Mayo score of 6 to 12 points with endoscopy subscore of 2 to 3 points confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy were to be enrolled at approximately 120 sites worldwide Planned enrollment was 500 participants
Participants were to be stratified by prior exposure to infliximab andor other anti-TNF agents and randomized in a 11 ratio to receive ADA or placebo by subcutaneous injection Participants assigned to the ADA treatment arm were to receive an induction dose of 160 mg at Week 0 and 80 mg at Week 2 and 40 mg every other week eow starting at Week 4 Participants assigned to the placebo treatment arm were to receive matching placebo during the same period of time At or after Week 10 participants who met the criteria for inadequate response could be switched to open-label OL ADA 40 mg eow beginning at Week 12 Inadequate response was defined as
Partial Mayo score greater than or equal to Baseline score on 2 consecutive visits at least 14 days apart for participants with a partial Mayo score of 4 to 7 at Baseline
Partial Mayo score greater than or equal to 7 on 2 consecutive visits at least 14 days apart for participants with a partial Mayo score of 8 or 9 at Baseline
Participants who demonstrated inadequate response at 2 consecutive visits at least 14 days apart while on OL administration ADA 40 mg eow were permitted to dose escalate to ADA 40 mg weekly ew Participants with persistent inadequate response while on ADA 40 mg ew may have been discontinued from the study at the Investigators discretion Upon completion of the study participants had the option to enroll into the OL extension Study M10-223 in which they could receive ADA treatment
Efficacy and safety measurements were performed throughout the study A follow-up phone call was made 70 days after the last dose of study drug to obtain information on any ongoing or new adverse events AEs for all participants who terminated early or who did not enroll in the OL extension study
The duration of the study was up to 65 weeks including a Screening Period of up to 3 weeks a double-blind DB placebo-controlled treatment period of up to 52 weeks and a 70 day follow-up phone call for participants who prematurely discontinued or who did not enroll in the extension study NCT 00573794 M10-223
Adult participants with moderate to severe UC Mayo score of 6 to 12 points with endoscopy subscore of 2 to 3 points confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy were to be enrolled at approximately 120 sites worldwide Planned enrollment was 500 participants
Participants were to be stratified by prior exposure to infliximab andor other anti-TNF agents and randomized in a 11 ratio to receive ADA or placebo by subcutaneous injection Participants assigned to the ADA treatment arm were to receive an induction dose of 160 mg at Week 0 and 80 mg at Week 2 and 40 mg every other week eow starting at Week 4 Participants assigned to the placebo treatment arm were to receive matching placebo during the same period of time At or after Week 10 participants who met the criteria for inadequate response could be switched to open-label OL ADA 40 mg eow beginning at Week 12 Inadequate response was defined as
Partial Mayo score greater than or equal to Baseline score on 2 consecutive visits at least 14 days apart for participants with a partial Mayo score of 4 to 7 at Baseline
Partial Mayo score greater than or equal to 7 on 2 consecutive visits at least 14 days apart for participants with a partial Mayo score of 8 or 9 at Baseline
Participants who demonstrated inadequate response at 2 consecutive visits at least 14 days apart while on OL administration ADA 40 mg eow were permitted to dose escalate to ADA 40 mg weekly ew Participants with persistent inadequate response while on ADA 40 mg ew may have been discontinued from the study at the Investigators discretion Upon completion of the study participants had the option to enroll into the OL extension Study M10-223 in which they could receive ADA treatment
Efficacy and safety measurements were performed throughout the study A follow-up phone call was made 70 days after the last dose of study drug to obtain information on any ongoing or new adverse events AEs for all participants who terminated early or who did not enroll in the OL extension 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 |
|---|---|---|---|
| 2006-002782-40 | EUDRACT_NUMBER | None | None |