Optimizing Cimzia in Crohn's Patients
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ClinicalTrials.gov Identifier: NCT01024647 |
Recruitment Status
: Unknown
Verified November 2012 by Douglas C. Wolf, MD, Atlanta Gastroenterology Associates.
Recruitment status was: Recruiting
First Posted
: December 3, 2009
Last Update Posted
: November 5, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Biological: certolizumab pegol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | December 2009 |
Estimated Primary Completion Date : | May 2013 |
Estimated Study Completion Date : | May 2013 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024647
Contact: Lamia S Mereby, BSN | 404-257-9000 ext 2142 | lamia.mereby@atlantagastro.com | |
Contact: Ashleigh K Arnold, BS | 404-257-9000 ext 2138 | ashleigh.kapperman@atlantagastro.com |
United States, Georgia | |
Atlanta Gastroenterology Associates | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Lamia S Mereby, BSN 404-257-9000 ext 2142 lamia.mereby@atlantagastro.com |
Principal Investigator: | Douglas C Wolf, MD | Atlanta Gastroenterology Associates |
Responsible Party: | Douglas C. Wolf, MD, Medical Director of Clinical Research, Atlanta Gastroenterology Associates |
ClinicalTrials.gov Identifier: | NCT01024647 History of Changes |
Other Study ID Numbers: |
CMZ-2010 |
First Posted: | December 3, 2009 Key Record Dates |
Last Update Posted: | November 5, 2012 |
Last Verified: | November 2012 |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Certolizumab Pegol Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |