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Optimizing Cimzia in Crohn's Patients

NCT ID: NCT01024647

Last Updated: 2012-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Loss of Reponse Reinduction Responders

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

Group Type ACTIVE_COMPARATOR

certolizumab pegol

Intervention Type BIOLOGICAL

certolizumab pegol 200 mg every 2 weeks

Response loss Reinduction Non-Responders

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

Group Type ACTIVE_COMPARATOR

certolizumab pegol

Intervention Type BIOLOGICAL

certolizumab pegol 400 mg every 2 weeks

Responders

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

Group Type ACTIVE_COMPARATOR

certolizumab pegol

Intervention Type BIOLOGICAL

certolizumab pegol 400 mg every 4 weeks

Non-Responders

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

Group Type ACTIVE_COMPARATOR

certolizumab pegol

Intervention Type BIOLOGICAL

certolizumab pegol 400 mg every 2 weeks

Interventions

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certolizumab pegol

certolizumab pegol 200 mg every 2 weeks

Intervention Type BIOLOGICAL

certolizumab pegol

certolizumab pegol 400 mg every 2 weeks

Intervention Type BIOLOGICAL

certolizumab pegol

certolizumab pegol 400 mg every 4 weeks

Intervention Type BIOLOGICAL

certolizumab pegol

certolizumab pegol 400 mg every 2 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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Cimzia Cimzia Cimzia Cimzia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

Atlanta Gastroenterology Associates

OTHER

Sponsor Role lead

Responsible Party

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Douglas C. Wolf, MD

Medical Director of Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas C Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Gastroenterology Associates

Locations

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Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lamia S Mereby, BSN

Role: CONTACT

Phone: 404-257-9000

Email: [email protected]

Ashleigh K Arnold, BS

Role: CONTACT

Phone: 404-257-9000

Email: [email protected]

Facility Contacts

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Lamia S Mereby, BSN

Role: primary

Other Identifiers

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CMZ-2010

Identifier Type: -

Identifier Source: org_study_id