Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Crohn's Disease
Interventions
BIOLOGICAL

Certolizumab pegol

"Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).~Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2."

Trial Locations (63)

Unknown

Birmingham

Montgomery

La Jolla

Oceanside

Palo Alto

Roseville

Lakewood

Clearwater

Gainesville

Hialeah

Jacksonville

North Miami Beach

Marietta

Savannah

Chicago

Bloomington

Davenport

Topeka

Bowling Green

Louisville

Metairie

Annapolis

Newton

Chesterfield

Dearborn

Troy

Minneapolis

Rochester

Kansas City

Mexico

New York

Syracuse

Chapel Hill

Charlotte

Raleigh

Cincinnati

Cleveland

Dayton

Tulsa

Columbia

Germantown

Austin

Salt Lake City

Burlington

Chesapeake

Richmond

Seattle

Milwaukee

Monroe

Edmonton

Abbottsford

Vancouver

Winnipeg

Halifax

London

Toronto

Saskatoon

Calgary

Frankfurt

Heidelberg

Jena

Rostock

Ulm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY