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A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033]

Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis

952

Started: 952 subjects (Japanese: 100 subjects) Female: 405 subjects (42.5%), Male: 547 subjects (57.5%) Age, mean (SD): 40.4 (12.98)

(Induction study) Started: 952 subjects, Not Completed: 106 subjects, Completed: 846 subjects (Maintenance study) Started: 846 subjects, Not Completed: 274 subjects, Completed: 572 subjects

All dosing regimens were well tolerated.

Induction: Clinical Response Rate in higher dosing regimen and standard dosing regimen were 13.8% and 11.6%, respectively. Maintenance: Significantly more Wk8 responders achieved clinical remission with 40mg EW vs 40mg EOW (41.1% vs 30.1%; p=0.045).

Proportion of subject who achieved endoscopic improvement at week8 in standard dosing regimen and higher dosing regimen were 26.9% and 30.5%, respectively. Proportion of subject who achieved endoscopic improvement at Week52 among Week8 responders per Mayo score in standard dosing regimen and higher dosing regimen were 41.7% and 52.0%, respectively.

Numerically greater efficacy for higher induction dosing regimen was demonstrated compared with standard induction dosing regimen. At Week52, clinical remission among Week8 responders was significantly higher with adalimumab 40mg EW vs 40mg EOW. All dosing regimens were well tolerated.

Yes

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AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie GK

+81-120-587-874

completed

July. 22, 2014

Interventional

Multicenter, Doble-Blind

treatment purpose

3

1.Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy with biopsy during Screening period.
2.Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

1.Subject with Crohn's disease (CD) or indeterminate colitis (IC).
2.Current diagnosis of fulminant colitis and/or toxic megacolon.
3.Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
4.Chronic recurring infections or active Tuberculosis (TB).

Both

Ulcerative Colitis

investigational material(s)
Generic name etc : adalimumab
INN of investigational material : adalimumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : subcutaneous injection

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : subcutaneous injection

efficacy
Proportion of subjects achieving clinical remission (per full Mayo Score) [ Time Frame: Week 8 ]
Proportion of Week 8 responders (per full Mayo Score) achieving clinical remission (per full Mayo Score) [ Time Frame: Week 52 ]

efficacy
Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 8 ]
Proportion of Week 8 responders (per full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 52 ]

April. 21, 2014