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An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).


Phase 3
18 Years
N/A
Not Enrolling
Both
Crohn's Disease

Thank you

Trial Information

An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).


Inclusion Criteria:



- Patients previously enrolled in C87059 (COSPAR I, NCT00349752)

Exclusion Criteria:

- Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under
specific conditions

- Subject who received treatment other than study medication and other than medications
permitted in C87059 (COSPAR I, NCT00349752)

- Subjects from countries where certolizumab pegol is authorized in Crohn's disease
treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)

Outcome Description:

Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.

Outcome Time Frame:

During this study (maximum 122 weeks)

Safety Issue:

No

Principal Investigator

UCB Clinical Trial Call Center

Investigator Role:

Study Director

Investigator Affiliation:

+1 877 822 9493 (UCB)

Authority:

United States: Food and Drug Administration

Study ID:

C87065

NCT ID:

NCT00356408

Start Date:

January 2007

Completion Date:

February 2010

Related Keywords:

  • Crohn's Disease
  • CDP870
  • certolizumab pegol
  • Crohn's Disease
  • Crohn Disease

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Kansas City, Kansas  66160
Metairie, Louisiana  70006
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
South Burlington, Vermont  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma  
Salt Lake City, Utah  84112