A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

Last updated: July 10, 2018
Sponsor: UCB Pharma SA
Overall Status: Completed

Phase

3

Condition

Colic

Crohn's Disease

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT00160706
C87034
2005-002623-13
  • Ages > 18
  • All Genders

Study Summary

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]clinical studies in which the subject completed the Week 2 assessment in CDP870-031 [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whoseCrohn's Disease was significantly worse as determined by the investigator and whoseClinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):
  1. At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6CDP870 032 [NCT00152425] responders) OR

  2. Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032 [NCT00152425] responders) with an absolute score of at least 350 points

  • Subjects must be able to understand the information provided to them and give writteninformed consent

Exclusion

Exclusion Criteria:

  • Any exclusion criterion that would have prevented the subject's participation in thequalifying pivotal study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]),although the upper limit of 450 in the CDAI score is not applicable. In addition thecriterion that excludes previous participation in a clinical trial of CertolizumabPegol does not apply

Study Design

Total Participants: 310
Study Start date:
February 01, 2004
Estimated Completion Date:
May 31, 2012

Connect with a study center

  • 11011

    Bankstown, New South Wales
    Australia

    Site Not Available

  • 11005

    New Lambton, New South Wales
    Australia

    Site Not Available

  • empty

    Brisbane, Queensland
    Australia

    Site Not Available

  • 11017

    Herston, Queensland
    Australia

    Site Not Available

  • 11006

    South Brisbane, Queensland
    Australia

    Site Not Available

  • 11014

    Lauceston, Tasmania
    Australia

    Site Not Available

  • 11016

    Ballarat, Victoria
    Australia

    Site Not Available

  • 11007

    Box Hill, Victoria
    Australia

    Site Not Available

  • 11002

    Fitzroy, Victoria
    Australia

    Site Not Available

  • 11013

    Frankston, Victoria
    Australia

    Site Not Available

  • 11012

    Parkville, Victoria
    Australia

    Site Not Available

  • 11009

    Adelaide,
    Australia

    Site Not Available

  • 11010

    Fremantle,
    Australia

    Site Not Available

  • 11015

    Garran,
    Australia

    Site Not Available

  • 11018

    Newtown,
    Australia

    Site Not Available

  • 46006

    Linz,
    Austria

    Site Not Available

  • 46003

    Salzburg,
    Austria

    Site Not Available

  • 46002

    Wien,
    Austria

    Site Not Available

  • 12001

    Minsk,
    Belarus

    Site Not Available

  • 13004

    Brussels,
    Belgium

    Site Not Available

  • 13001

    Gent,
    Belgium

    Site Not Available

  • 13003

    Leuven,
    Belgium

    Site Not Available

  • 15001

    Sofia,
    Bulgaria

    Site Not Available

  • 16005

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • 16014

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • 16013

    Toronto, Ontario
    Canada

    Site Not Available

  • 16008

    Montreal, Quebec
    Canada

    Site Not Available

  • 18006

    Hradek Kralove,
    Czechia

    Site Not Available

  • 18001

    Ostrava,
    Czechia

    Site Not Available

  • 18004

    Praha 2,
    Czechia

    Site Not Available

  • 18002

    Praha 4,
    Czechia

    Site Not Available

  • 19004

    Aalborg,
    Denmark

    Site Not Available

  • 19009

    Copenhagen,
    Denmark

    Site Not Available

  • 19010

    Herlev,
    Denmark

    Site Not Available

  • 19007

    Hvidovre,
    Denmark

    Site Not Available

  • 19003

    Vejle,
    Denmark

    Site Not Available

  • 20001

    Tallin,
    Estonia

    Site Not Available

  • 20002

    Tartu,
    Estonia

    Site Not Available

  • 22002

    Berlin,
    Germany

    Site Not Available

  • 22009

    Berlin,
    Germany

    Site Not Available

  • 22004

    Celle,
    Germany

    Site Not Available

  • 22019

    Frankfurt,
    Germany

    Site Not Available

  • empty

    Gottingen,
    Germany

    Site Not Available

  • 22013

    Göttingen,
    Germany

    Site Not Available

  • 22013

    Göttingen,
    Germany

    Site Not Available

  • 22017

    Hannover,
    Germany

    Site Not Available

  • 22015

    Kiel,
    Germany

    Site Not Available

  • 22016

    Leipzig,
    Germany

    Site Not Available

  • 22001

    Minden,
    Germany

    Site Not Available

  • 22012

    Munich,
    Germany

    Site Not Available

  • empty

    Munster,
    Germany

    Site Not Available

  • 22008

    Münster,
    Germany

    Site Not Available

  • 22008

    Münster,
    Germany

    Site Not Available

  • 24002

    Budapest,
    Hungary

    Site Not Available

  • 24009

    Pecs,
    Hungary

    Site Not Available

  • 24011

    Szekszard,
    Hungary

    Site Not Available

  • 26004

    Beer Sheva,
    Israel

    Site Not Available

  • 26007

    Haifa,
    Israel

    Site Not Available

  • 26005

    Petha Tikva,
    Israel

    Site Not Available

  • 27001

    Milano,
    Italy

    Site Not Available

  • 27004

    Palermo,
    Italy

    Site Not Available

  • 27007

    Roma,
    Italy

    Site Not Available

  • 31002

    Auckland,
    New Zealand

    Site Not Available

  • 31001

    Christchurch,
    New Zealand

    Site Not Available

  • 31005

    Hamilton,
    New Zealand

    Site Not Available

  • 31004

    Milford,
    New Zealand

    Site Not Available

  • 31003

    Tauranga,
    New Zealand

    Site Not Available

  • 32005

    Oslo,
    Norway

    Site Not Available

  • 32008

    Oslo,
    Norway

    Site Not Available

  • 32004

    Tromso,
    Norway

    Site Not Available

  • 33008

    Bydgoszcz,
    Poland

    Site Not Available

  • 33003

    Gdansk,
    Poland

    Site Not Available

  • 33018

    Lublin,
    Poland

    Site Not Available

  • 33013

    Szczecin,
    Poland

    Site Not Available

  • 33007

    Warsaw,
    Poland

    Site Not Available

  • 33009

    Warszawa,
    Poland

    Site Not Available

  • 34017

    Lipetsk,
    Russian Federation

    Site Not Available

  • 34006

    Moscow,
    Russian Federation

    Site Not Available

  • 34016

    Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • 34001

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 34005

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 34007

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 34013

    St. Petersburg,
    Russian Federation

    Site Not Available

  • 35001

    Belgrade,
    Serbia

    Site Not Available

  • 35002

    Belgrade,
    Serbia

    Site Not Available

  • 35004

    Belgrade,
    Serbia

    Site Not Available

  • 36002

    Singapore,
    Singapore

    Site Not Available

  • 38001

    Celje,
    Slovenia

    Site Not Available

  • 38003

    Ljubljana,
    Slovenia

    Site Not Available

  • 39013

    Johannesburg, Gauteng
    South Africa

    Site Not Available

  • 39003

    Cape Town, Somerset West
    South Africa

    Site Not Available

  • 39016

    Cape Town,
    South Africa

    Site Not Available

  • 39018

    Cape Town,
    South Africa

    Site Not Available

  • 39012

    Goodwood,
    South Africa

    Site Not Available

  • 39010

    Johannesburg,
    South Africa

    Site Not Available

  • 39008

    Midrand,
    South Africa

    Site Not Available

  • 39004

    PORT Elisabeth,
    South Africa

    Site Not Available

  • 39006

    Pretoria,
    South Africa

    Site Not Available

  • 39009

    Pretoria,
    South Africa

    Site Not Available

  • 39014

    Pretoria,
    South Africa

    Site Not Available

  • 39019

    Pretoria,
    South Africa

    Site Not Available

  • 40009

    Barcelona,
    Spain

    Site Not Available

  • 43008

    Dniepropetrovsk,
    Ukraine

    Site Not Available

  • 43003

    Lviv,
    Ukraine

    Site Not Available

  • 43006

    Odessa,
    Ukraine

    Site Not Available

  • 45102

    Birmingham, Alabama
    United States

    Site Not Available

  • 45028

    Huntsville, Alabama
    United States

    Site Not Available

  • 45044

    Little Rock, Arkansas
    United States

    Site Not Available

  • 45095

    Orange, California
    United States

    Site Not Available

  • 45101

    San Francisco, California
    United States

    Site Not Available

  • 45101

    San Fransisco, California
    United States

    Site Not Available

  • 45130

    Colorado Springs, Colorado
    United States

    Site Not Available

  • 45094

    Gainesville, Florida
    United States

    Site Not Available

  • 45094

    Gainsville, Florida
    United States

    Site Not Available

  • 45005

    Hialeah, Florida
    United States

    Site Not Available

  • 45087

    Miami, Florida
    United States

    Site Not Available

  • 45004

    North Miami Beach, Florida
    United States

    Site Not Available

  • 45016

    Chicago, Illinois
    United States

    Site Not Available

  • 45037

    Indianapolis, Indiana
    United States

    Site Not Available

  • 45019

    Lexington, Kentucky
    United States

    Site Not Available

  • 45033

    Chevy Chase, Maryland
    United States

    Site Not Available

  • 45013

    Laurel, Maryland
    United States

    Site Not Available

  • 45083

    Rochester, Minnesota
    United States

    Site Not Available

  • 45108

    Jefferson City, Missouri
    United States

    Site Not Available

  • 45035

    Berlin, New Jersey
    United States

    Site Not Available

  • 45009

    Great Neck, New York
    United States

    Site Not Available

  • 45070

    New York, New York
    United States

    Site Not Available

  • 45145

    Greenville, North Carolina
    United States

    Site Not Available

  • 45067

    High Point, North Carolina
    United States

    Site Not Available

  • 45003

    Raleigh, North Carolina
    United States

    Site Not Available

  • 45040

    Winston-Salem, North Carolina
    United States

    Site Not Available

  • 45081

    Cincinnati, Ohio
    United States

    Site Not Available

  • 45091

    Cincinnati, Ohio
    United States

    Site Not Available

  • 45054

    Dayton, Ohio
    United States

    Site Not Available

  • 45025

    Mayfield Heights, Ohio
    United States

    Site Not Available

  • 45039

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • 45041

    Tulsa, Oklahoma
    United States

    Site Not Available

  • 45093

    Hershey, Pennsylvania
    United States

    Site Not Available

  • empty

    Jefferson, Pennsylvania
    United States

    Site Not Available

  • 45113

    Germantown, Tennessee
    United States

    Site Not Available

  • 45119

    Nashville, Tennessee
    United States

    Site Not Available

  • 45022

    Houston, Texas
    United States

    Site Not Available

  • 45073

    San Antonio, Texas
    United States

    Site Not Available

  • 45139

    Salt Lake City, Utah
    United States

    Site Not Available

  • 45052

    South Ogden, Utah
    United States

    Site Not Available

  • 45134

    Charlottesville, Virginia
    United States

    Site Not Available

  • 45078

    Christiansburg, Virginia
    United States

    Site Not Available

  • 45109

    Norfolk, Virginia
    United States

    Site Not Available

  • 45141

    Seattle, Washington
    United States

    Site Not Available

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