Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2080222597
- Lead Sponsor
- AbbVie GK
- Brief Summary
umerically 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 952
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Proportion of subjects achieving clinical remission (per full Mayo Score) [ Time Frame: Week 8 ]<br>Proportion of Week 8 responders (per full Mayo Score) achieving clinical remission (per full Mayo Score) [ Time Frame: Week 52 ]
- Secondary Outcome Measures
Name Time Method efficacy<br>Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 8 ]<br>Proportion of Week 8 responders (per full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 52 ]