A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00358683 |
Recruitment Status :
Withdrawn
First Posted : August 1, 2006
Last Update Posted : May 28, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: Certolizumab pegol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study. |
Study Start Date : | November 2007 |

- For ethical reasons, provide the opportunity for patients > 18 years suffering from Crohn's disease who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizum
- Incidence of adverse events reported by the patients during the long-term treatment period of the study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- Crohn's disease diagnosis
- Patients having completed the treatment period of study C87055 (previously treated with infliximab) and benefited from the study treatment, as per investigatior's discretion.
Exclusion Criteria:
- Subject withdrawn prematurely from C87055 study.
- Subject who received treatment other than certolizumab pegol and other than medications permitted in C87055 study.
- Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration.

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): NCT00358683
Study Director: | George Syrmalis, M.D. M.Sc. Ph.D. | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00358683 |
Other Study ID Numbers: |
C87069 RPCE06G0406 |
First Posted: | August 1, 2006 Key Record Dates |
Last Update Posted: | May 28, 2012 |
Last Verified: | May 2012 |
certolizunab pegol long term safety follow-up Chrohn's disease infliximab failures patients Greek population |
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 |