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Optimizing Cimzia in Crohn's Patients

Primary Purpose

Crohn's Disease

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
certolizumab pegol
certolizumab pegol
certolizumab pegol
certolizumab pegol
Sponsored by
Atlanta Gastroenterology Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atlanta Gastroenterology AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Loss of Reponse Reinduction Responders

Response loss Reinduction Non-Responders

Responders

Non-Responders

Arm Description

Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks

Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks

Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks

Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index
≥ 100 point decrease in CDAI represents response

Secondary Outcome Measures

Full Information

First Posted
December 2, 2009
Last Updated
November 1, 2012
Sponsor
Atlanta Gastroenterology Associates
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01024647
Brief Title
Optimizing Cimzia in Crohn's Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlanta Gastroenterology Associates
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Loss of Reponse Reinduction Responders
Arm Type
Active Comparator
Arm Description
Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks
Arm Title
Response loss Reinduction Non-Responders
Arm Type
Active Comparator
Arm Description
Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks
Arm Title
Responders
Arm Type
Active Comparator
Arm Description
Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks
Arm Title
Non-Responders
Arm Type
Active Comparator
Arm Description
Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks
Intervention Type
Biological
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia
Intervention Description
certolizumab pegol 200 mg every 2 weeks
Intervention Type
Biological
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia
Intervention Description
certolizumab pegol 400 mg every 2 weeks
Intervention Type
Biological
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia
Intervention Description
certolizumab pegol 400 mg every 4 weeks
Intervention Type
Biological
Intervention Name(s)
certolizumab pegol
Other Intervention Name(s)
Cimzia
Intervention Description
certolizumab pegol 400 mg every 2 weeks
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index
Description
≥ 100 point decrease in CDAI represents response
Time Frame
26 Weeks, if responder up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lamia S Mereby, BSN
Phone
404-257-9000
Ext
2142
Email
lamia.mereby@atlantagastro.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashleigh K Arnold, BS
Phone
404-257-9000
Ext
2138
Email
ashleigh.kapperman@atlantagastro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas C Wolf, MD
Organizational Affiliation
Atlanta Gastroenterology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lamia S Mereby, BSN
Phone
404-257-9000
Ext
2142
Email
lamia.mereby@atlantagastro.com

12. IPD Sharing Statement

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Optimizing Cimzia in Crohn's Patients

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