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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00552344
First received: October 31, 2007
Last updated: August 20, 2014
Last verified: August 2014
  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 3

Study Type: Interventional
Study Design: 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:


Further study details as provided by UCB Pharma:

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 ]

Enrollment: 402
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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
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, see Learn About Clinical Studies.

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

  Show 100 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00552344     History of Changes
Other Study ID Numbers: C87088, 2007-002716-26
Study First Received: October 31, 2007
Last Updated: August 20, 2014
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 Pública 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 Pharma:
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
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014