Study to Assess the Safety of CDP870 for up to 30 Months Following Reintroduction of Treatment - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00160706

Purpose

A follow-on safety study in patients with Crohn's disease who have previously been withdrawn from study CDP870-031 or CDP870-032 due to an exacerbation of Crohn's disease.

Condition	Intervention	Phase
Crohn's Disease	Biological: CDP870	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III Multi-National, Multi-Centre, Open Label, Safety Study to Assess the Safety of re-Exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

Further study details as provided by UCB:

Primary Outcome Measures:

Long-term Safety: Adverse Event, Clinical Laboratory Evaluations [ Time Frame: 1 year ]

Secondary Outcome Measures:

Plasma concentration of CDP870 [ Time Frame: 1 year ]
Antibodies to CDP870 [ Time Frame: 1 year ]
Efficacy: Harvey Bradshaw Index [ Time Frame: 1 year ]
Efficacy: Fecal Calprotein [ Time Frame: 1 year ]
Efficacy: CRP [ Time Frame: 1 year ]

Enrollment:	310
Study Start Date:	February 2004
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open label administration of CDP870	Biological: CDP870 CDP870 400mg injection, subcutaneous every 4 weeks, last application: week 204

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3). Vienna Classification (1998)
Active Crohn's disease (between 220 and 450) scored over the 7 days prior to the first dose of study drug.
Patients aged 18 years or above at screening.
Patient must have been discontinued from either protocol CDP870-031 or CDP870-032

Exclusion Criteria:

Crohn's Disease Related
Fistula abscess present at screening.
Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
Short bowel syndrome.
Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
Positive stool laboratory results for enteric pathogens.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160706

Show 128 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87034
Study First Received:	September 8, 2005
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00160706
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Ministry for Health and Women; Belarus: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Estonia: The State Agency of Medicine; Germany: Paul-Ehrlich-Institut; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: Ministry of Health; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; New Zealand: Food Safety Authority; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Singapore: Health Sciences Authority; Slovenia: Agency for Medicinal Products - Ministry of Health; South Africa: Medicines Control Council; Spain: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration

Keywords provided by UCB:

Crohn's disease, CDP870, CDAI, clinical response, remission,
Certolizumab Pegol, Cimzia

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009