A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
NCT ID: NCT00160706
Last Updated: 2018-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2004-02-29
2012-05-31
Brief Summary
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A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
NCT00160524
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
NCT00333788
A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)
NCT00152490
Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).
NCT00152425
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
NCT00329420
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Certolizumab Pegol
3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Certolizumab Pegol (CDP870)
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study.
Interventions
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Certolizumab Pegol (CDP870)
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. At least 70 points higher then Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870 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 written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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UCB Pharma SA
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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45102
Birmingham, Alabama, United States
45028
Huntsville, Alabama, United States
45044
Little Rock, Arkansas, United States
45095
Orange, California, United States
45101
San Francisco, California, United States
45130
Colorado Springs, Colorado, United States
45094
Gainesville, Florida, United States
45005
Hialeah, Florida, United States
45087
Miami, Florida, United States
45004
North Miami Beach, Florida, United States
45016
Chicago, Illinois, United States
45037
Indianapolis, Indiana, United States
45019
Lexington, Kentucky, United States
45033
Chevy Chase, Maryland, United States
45013
Laurel, Maryland, United States
45083
Rochester, Minnesota, United States
45108
Jefferson City, Missouri, United States
45035
Berlin, New Jersey, United States
45009
Great Neck, New York, United States
45070
New York, New York, United States
45145
Greenville, North Carolina, United States
45067
High Point, North Carolina, United States
45003
Raleigh, North Carolina, United States
45040
Winston-Salem, North Carolina, United States
45081
Cincinnati, Ohio, United States
45091
Cincinnati, Ohio, United States
45054
Dayton, Ohio, United States
45025
Mayfield Heights, Ohio, United States
45039
Oklahoma City, Oklahoma, United States
45041
Tulsa, Oklahoma, United States
45093
Hershey, Pennsylvania, United States
45113
Germantown, Tennessee, United States
45119
Nashville, Tennessee, United States
45022
Houston, Texas, United States
45073
San Antonio, Texas, United States
45139
Salt Lake City, Utah, United States
45052
South Ogden, Utah, United States
45134
Charlottesville, Virginia, United States
45078
Christiansburg, Virginia, United States
45109
Norfolk, Virginia, United States
45141
Seattle, Washington, United States
11011
Bankstown, New South Wales, Australia
11005
New Lambton, New South Wales, Australia
11017
Herston, Queensland, Australia
11006
South Brisbane, Queensland, Australia
11014
Lauceston, Tasmania, Australia
11016
Ballarat, Victoria, Australia
11007
Box Hill, Victoria, Australia
11002
Fitzroy, Victoria, Australia
11013
Frankston, Victoria, Australia
11012
Parkville, Victoria, Australia
11009
Adelaide, , Australia
11010
Fremantle, , Australia
11015
Garran, , Australia
11018
Newtown, , Australia
46006
Linz, , Austria
46003
Salzburg, , Austria
46002
Vienna, , Austria
12001
Minsk, , Belarus
13004
Brussels, , Belgium
13001
Ghent, , Belgium
13003
Leuven, , Belgium
15001
Sofia, , Bulgaria
16005
Winnipeg, Manitoba, Canada
16014
Halifax, Nova Scotia, Canada
16013
Toronto, Ontario, Canada
16008
Montreal, Quebec, Canada
18006
Hradek Kralove, , Czechia
18001
Ostrava, , Czechia
18002
Prague, , Czechia
18004
Prague, , Czechia
19004
Aalborg, , Denmark
19009
Copenhagen, , Denmark
19010
Herlev, , Denmark
19007
Hvidovre, , Denmark
19003
Vejle, , Denmark
20001
Tallinn, , Estonia
20002
Tartu, , Estonia
22002
Berlin, , Germany
22009
Berlin, , Germany
22004
Celle, , Germany
22019
Frankfurt, , Germany
22013
Göttingen, , Germany
22017
Hanover, , Germany
22015
Kiel, , Germany
22016
Leipzig, , Germany
22001
Minden, , Germany
22012
Munich, , Germany
22008
Münster, , Germany
24002
Budapest, , Hungary
24009
Pécs, , Hungary
24011
Szekszárd, , Hungary
26004
Beersheba, , Israel
26007
Haifa, , Israel
26005
Petha Tikva, , Israel
27001
Milan, , Italy
27004
Palermo, , Italy
27007
Roma, , Italy
31002
Auckland, , New Zealand
31001
Christchurch, , New Zealand
31005
Hamilton, , New Zealand
31004
Milford, , New Zealand
31003
Tauranga, , New Zealand
32005
Oslo, , Norway
32008
Oslo, , Norway
32004
Tromsø, , Norway
33008
Bydgoszcz, , Poland
33003
Gdansk, , Poland
33018
Lublin, , Poland
33013
Szczecin, , Poland
33007
Warsaw, , Poland
33009
Warsaw, , Poland
34017
Lipetsk, , Russia
34006
Moscow, , Russia
34016
Nizhny Novgorod, , Russia
34001
Saint Petersburg, , Russia
34005
Saint Petersburg, , Russia
34007
Saint Petersburg, , Russia
34013
Saint Petersburg, , Russia
35001
Belgrade, , Serbia
35002
Belgrade, , Serbia
35004
Belgrade, , Serbia
36002
Singapore, , Singapore
38001
Celje, , Slovenia
38003
Ljubljana, , Slovenia
39013
Johannesburg, Gauteng, South Africa
39003
Cape Town, Somerset West, South Africa
39016
Cape Town, , South Africa
39018
Cape Town, , South Africa
39012
Goodwood, , South Africa
39010
Johannesburg, , South Africa
39008
Midrand, , South Africa
39004
Port Elizabeth, , South Africa
39006
Pretoria, , South Africa
39009
Pretoria, , South Africa
39014
Pretoria, , South Africa
39019
Pretoria, , South Africa
40009
Barcelona, , Spain
43008
Dniepropetrovsk, , Ukraine
43003
Lviv, , Ukraine
43006
Odesa, , Ukraine
Countries
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References
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Sandborn WJ, Schreiber S, Hanauer SB, Colombel JF, Bloomfield R, Lichtenstein GR; PRECiSE 4 Study Investigators. Reinduction with certolizumab pegol in patients with relapsed Crohn's disease: results from the PRECiSE 4 Study. Clin Gastroenterol Hepatol. 2010 Aug;8(8):696-702.e1. doi: 10.1016/j.cgh.2010.03.024. Epub 2010 Apr 2.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2005-002623-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87034
Identifier Type: -
Identifier Source: org_study_id
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