A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease - Full Text View

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00552344

Purpose

The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085.

Condition	Intervention	Phase
Crohn Disease	Biological: Certolizumab Pegol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase IIIb, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Safety of the long term therapy with certolizumab. All summaries of continuous safety variables will be presented at scheduled time points. Data to be analyzed will be adverse event data, laboratory data, vital signs and urinalysis data. [ Time Frame: 262 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Obtain long term efficacy data. [ Time Frame: 262 weeks ] [ Designated as safety issue: No ]
Obtain data on plasma concentration of certolizumab pegol. [ Time Frame: 262 weeks ] [ Designated as safety issue: No ]
Obtain data on plasma concentration of ds-DNA and ANA. [ Time Frame: 262 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CDP870	Biological: Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks. Other Name: Cimzia

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects participated in study C87085

Exclusion Criteria:

General exclusion criteria as common for open-label extension studies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552344

Show 100 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00552344 History of Changes
Other Study ID Numbers:	C87088, EudraCT Number: 2007-002716-26
Study First Received:	October 31, 2007
Last Updated:	February 6, 2012
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: Ministry of Health; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: Finnish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Israel: Ministry of Health; Italy: National Institute of Health; Latvia: State Agency of Medicines; New Zealand: Health Research Council; Poland: Ministry of Health; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; Ukraine: Ministry of Health

Keywords provided by UCB, Inc.:

CDP 870
Certolizumab Pegol
CIMZIA
Crohn Disease

Crohn's disease
Induction
Clinical response
Clinical remission

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012