Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- To determine the proportion of patients achieving clinical response determined by patient reported symptoms and investigator's assessment of mucosal healing via endoscopy measured by Total Mayo Score at Week 14 compared to Week 0.
Study Overview
Brief Summary
The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective treatment for patients with Ulcerative colitis.
Detailed Description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often results in significant morbidity as well as impairment in quality of life. Cimzia (certolizumab pegol), an inhibitor of tumor necrosis factor-alpha, is an effective treatment for Crohn's disease, a similar inflammatory bowel disease. The aims of this study are to determine if Cimzia is effective for both the induction and maintenance of response/remission for the patients with moderate to severe Ulcerative colitis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cimzia
Treatment with open label Cimzia (certolizumab pegol)
Intervention: Cimzia (Drug)
Outcomes
Primary Outcomes
To determine the proportion of patients achieving clinical response determined by patient reported symptoms and investigator's assessment of mucosal healing via endoscopy measured by Total Mayo Score at Week 14 compared to Week 0.
Time Frame: Week 14
Clinical response is defined as a decrease in the Total Mayo Score of at least 3 points by Week 14 compared to Week 0.
Secondary Outcomes
- To determine the proportion of patients achieving clinical response or clinical remission at week 54 per the same criteria as listed above.(Week 54)
- To determine the change in mean or median serum CRP levels between week 0 and week 54(Week 54)
- To determine the change in mean or median IBDQ or SIBDQ scores between week 0 and week 54(Week 54)
- To determine the proportion of patients achieving clinical remission determined by patient reported symptoms and investigator's assessment of mucosal healing via endoscopy measured by Total Mayo Score at Week 14 compared to Week 0.(Week 14)
- To determine the proportion of patients achieving mucosal healing at weeks 14 and 54 defined as a Mayo endoscopic subscore less than 2.(Week 14/54)
- To determine the corticosteroid-sparing effects of certolizumab pegol over a years treatment time.(Week 54)
- To determine the colectomy rate between week 0 and week 54(Week 54)
- To determine the change in mean or median total or partial Mayo score between week 0 and week 54(Week 54)
- To determine all adverse events, serious adverse events, opportunistic infections, and injection site reactions between week 0 and week 64(Week 64)
Investigators
Scott Lee
Associate Professor, Medicine/Division of Gastroenterology
University of Washington