Study of Cimzia for the Treatment of Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Cimzia

• Registration Number: NCT01090154
• Lead Sponsor: University of Washington

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 Timeline

• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-19
• Study Start: 2010-12-01
• Status Verified: 2021-12
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cimzia	Cimzia	Treatment with open label Cimzia (certolizumab pegol)

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	Clinical remission is defined as a total Mayo score of less than or equal to 2 with no individual subscore greater than 1 at Week 14 compared to Week 0.
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 if patients are able to remain off steroids and maintain response or remission with certolizumab pegol alone and not necessitate concomitant treatment with steroids.
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

Trial Locations

Locations (2)

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States