Optimizing Cimzia in Crohn's Patients

November 1, 2012 updated by: Douglas C. Wolf, MD, Atlanta Gastroenterology Associates

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ileal and/or colonic Crohn's disease
  • moderate to severe Crohn's disease

Exclusion Criteria:

  • short bowel syndrome
  • ostomy
  • anti-TNF therapy within 4 weeks
  • prior certolizumab therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Loss of Reponse Reinduction Responders
Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks
Biological: certolizumab pegol
certolizumab pegol 200 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 4 weeks
Other Names:
  • Cimzia
Active Comparator: Response loss Reinduction Non-Responders
Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks
Biological: certolizumab pegol
certolizumab pegol 200 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 4 weeks
Other Names:
  • Cimzia
Active Comparator: Responders
Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks
Biological: certolizumab pegol
certolizumab pegol 200 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 4 weeks
Other Names:
  • Cimzia
Active Comparator: Non-Responders
Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks
Biological: certolizumab pegol
certolizumab pegol 200 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 2 weeks
Other Names:
  • Cimzia
Biological: certolizumab pegol
certolizumab pegol 400 mg every 4 weeks
Other Names:
  • Cimzia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crohn's Disease Activity Index
Time Frame: 26 Weeks, if responder up to 52 weeks
≥ 100 point decrease in CDAI represents response
26 Weeks, if responder up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlanta Gastroenterology Associates

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: Douglas C Wolf, MD, Atlanta Gastroenterology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 4, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMZ-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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