Optimizing Cimzia in Crohn's Patients | NCT01024647

Studies
Optimizing Cimzia in Crohn's Patients

NCT01024647

Sponsor

Atlanta Gastroenterology Associates

Status

Unknown status

Last Update Posted

Nov 5, 2012Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Crohn's Disease

Interventions

certolizumab pegol
certolizumab pegol
certolizumab pegol
certolizumab pegol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2012

Last Update Posted Date

Nov 5, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Douglas C. Wolf, MD, Medical Director of Clinical Research, Atlanta Gastroenterology AssociatesPrincipal Investigator

Lead Sponsor

Atlanta Gastroenterology AssociatesOTHER

Collaborators

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Loss of Reponse Reinduction Responders	Active Comparator	Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks	Biological: certolizumab pegol
Response loss Reinduction Non-Responders	Active Comparator	Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks	Biological: certolizumab pegol
Responders	Active Comparator	Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks	Biological: certolizumab pegol
Non-Responders	Active Comparator	Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks	Biological: certolizumab pegol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
certolizumab pegol	Biological	certolizumab pegol 200 mg every 2 weeks	Loss of Reponse Reinduction Responders

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lamia S Mereby, BSN	Contact	404-257-9000	2142	lamia.mereby@atlantagastro.com
Ashleigh K Arnold, BS	Contact	404-257-9000	2138	ashleigh.kapperman@atlantagastro.com

Overall Officials

Name	Affiliation	Role
Douglas C Wolf, MD	Atlanta Gastroenterology Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atlanta Gastroenterology Associates	Recruiting	Atlanta	Georgia	30342	United States

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068582	Certolizumab Pegol

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments

Browse Leaves

Not provided

Browse Branches

Not provided