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, Inc.
ClinicalTrials.gov Identifier:
NCT00552344
First received: October 31, 2007
Last updated: June 4, 2014
Last verified: June 2014

October 31, 2007
June 4, 2014
May 2008
December 2014   (final data collection date for primary outcome measure)
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 ]
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: 50 weeks ]
Complete list of historical versions of study NCT00552344 on ClinicalTrials.gov Archive Site
  • 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 ]
The absolute and the change from baseline for the HBI, CDAI and IBDQ scores will be summarized over time. [ Time Frame: 50 weeks ]
Not Provided
Not Provided
 
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn Disease
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
Experimental: CDP870
Intervention: Biological: Certolizumab Pegol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
402
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects participated in study C87085

Exclusion Criteria:

  • General exclusion criteria as common for open-label extension studies
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Estonia,   Germany,   Hungary,   Israel,   Italy,   Latvia,   New Zealand,   Poland,   Romania,   Russian Federation,   Ukraine
 
NCT00552344
C87088, 2007-002716-26
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP