Optimizing Cimzia in Crohn's Patients
Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 2, 2009
CompletedFirst Posted
Study publicly available on registry
December 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 5, 2012
November 1, 2012
3.4 years
December 2, 2009
November 1, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Crohn's Disease Activity Index
≥ 100 point decrease in CDAI represents response
26 Weeks, if responder up to 52 weeks
Study Arms (4)
Loss of Reponse Reinduction Responders
ACTIVE COMPARATORLoss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks
Response loss Reinduction Non-Responders
ACTIVE COMPARATORResponse Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks
Responders
ACTIVE COMPARATORResponders: certolizumab pegol(Cimzia) 400 mg every 4 weeks
Non-Responders
ACTIVE COMPARATORNon-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks
Interventions
certolizumab pegol 200 mg every 2 weeks
Eligibility Criteria
You may qualify if:
- ileal and/or colonic Crohn's disease
- moderate to severe Crohn's disease
You may not qualify if:
- short bowel syndrome
- ostomy
- anti-TNF therapy within 4 weeks
- prior certolizumab therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atlanta Gastroenterology Associateslead
- UCB Pharmacollaborator
Study Sites (1)
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas C Wolf, MD
Atlanta Gastroenterology Associates
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director of Clinical Research
Study Record Dates
First Submitted
December 2, 2009
First Posted
December 3, 2009
Study Start
December 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 5, 2012
Record last verified: 2012-11