The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Chevy Chase, Maryland, United States
Number of Subjects Without Mucosal Ulceration at Week 12
Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.
Time frame: Week 12
Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12
Clinical remission is defined as a CDAI less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.
Time frame: Week 12
Number of Subjects Without Mucosal Ulceration at Week 52
The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at Week 52.
Time frame: Week 52
Number of Subjects With Clinical Remission (CDAI < 150) at Week 52
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.
Time frame: Week 52
Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52
The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at both Week 12 and Week 52.
Time frame: Weeks 12 and 52
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At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.
Unnamed facility
Plymouth, Minnesota, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Mexico, Missouri, United States
Unnamed facility
Great Neck, New York, United States
Unnamed facility
Vienna, Austria
Unnamed facility
Bonheiden, Belgium
Unnamed facility
Leuven, Belgium
...and 11 more locations
Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.
Time frame: Weeks 12 and 52