Open-Label Adalimumab for Ulcerative Colitis Patients
Phase 1
Completed
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00421642
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This is an open-label study of 20 patients designed to demonstrate the safety, tolerability and preliminary evidence of benefit of adalimumab in the treatment of subjects with Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who have lost response or developed intolerance to previous infliximab therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Primary pilot efficacy variable will be the induction of clinical response, which is defined as a decrease in Mayo score less than 30% from baseline or less than 3 points PLUS decrease in rectal bleeding sub-score less than or equal to 1 at week 8 24 Weeks
- Secondary Outcome Measures
Name Time Method Improvement in the mucosal inflammation at week 8 24 Weeks Mayo Score 24 Weeks Clinical response at each visit 24 Weeks Clinical remission at each visit 24 Weeks Ability to taper and discontinue steroids according to the tapering schedule after week 8 24 Weeks
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Chicago
🇺🇸Chicago, Illinois, United States