Clinical trial NCT00356408: Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: CDP870
certolizumab pegol
Crohn's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).


Eligibility criteria: 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* Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions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

Primary outcomes:
measure: Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
timeFrame: During this study (maximum 122 weeks)
Secondary outcomes:
measure: Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
timeFrame: Week 34 in this study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: La Jolla
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Roseville
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Bloomington
country: United States
state: Indiana
city: Davenport
country: United States
state: Iowa
city: Topeka
country: United States
state: Kansas
city: Bowling Green
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Newton
country: United States
state: Massachusetts
city: Chesterfield
country: United States
state: Michigan
city: Dearborn
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Mexico
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Columbia
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Chesapeake
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Monroe
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
city: Abbottsford
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Calgary
country: Canada
city: Frankfurt
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Rostock
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: