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NCT00160706 Clinical Trial

A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

Crohn's Disease Clinical Trial

— PRECiSE 4  

Official title:
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00160706
Other study ID # C87034
Secondary ID 2005-002623-13
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2004
Est. completion date May 2012

Study information
Verified date May 2013
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.

Recruitment information / eligibility
Status Completed
Enrollment 310
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical 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 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:

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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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.

Locations
Country Name City State
Australia 11009 Adelaide
Australia 11016 Ballarat Victoria
Australia 11011 Bankstown New South Wales
Australia 11007 Box Hill Victoria
Australia 11002 Fitzroy Victoria
Australia 11013 Frankston Victoria
Australia 11010 Fremantle
Australia 11015 Garran
Australia 11017 Herston Queensland
Australia 11014 Lauceston Tasmania
Australia 11005 New Lambton New South Wales
Australia 11018 Newtown
Australia 11012 Parkville Victoria
Australia 11006 South Brisbane Queensland
Austria 46006 Linz
Austria 46003 Salzburg
Austria 46002 Wien
Belarus 12001 Minsk
Belgium 13004 Brussels
Belgium 13001 Gent
Belgium 13003 Leuven
Bulgaria 15001 Sofia
Canada 16014 Halifax Nova Scotia
Canada 16008 Montreal Quebec
Canada 16013 Toronto Ontario
Canada 16005 Winnipeg Manitoba
Czechia 18006 Hradek Kralove
Czechia 18001 Ostrava
Czechia 18004 Praha 2
Czechia 18002 Praha 4
Denmark 19004 Aalborg
Denmark 19009 Copenhagen
Denmark 19010 Herlev
Denmark 19007 Hvidovre
Denmark 19003 Vejle
Estonia 20001 Tallin
Estonia 20002 Tartu
Germany 22002 Berlin
Germany 22009 Berlin
Germany 22004 Celle
Germany 22019 Frankfurt
Germany 22013 Göttingen
Germany 22017 Hannover
Germany 22015 Kiel
Germany 22016 Leipzig
Germany 22001 Minden
Germany 22012 Munich
Germany 22008 Münster
Hungary 24002 Budapest
Hungary 24009 Pecs
Hungary 24011 Szekszard
Israel 26004 Beer Sheva
Israel 26007 Haifa
Israel 26005 Petha Tikva
Italy 27001 Milano
Italy 27004 Palermo
Italy 27007 Roma
New Zealand 31002 Auckland
New Zealand 31001 Christchurch
New Zealand 31005 Hamilton
New Zealand 31004 Milford
New Zealand 31003 Tauranga
Norway 32005 Oslo
Norway 32008 Oslo
Norway 32004 Tromso
Poland 33008 Bydgoszcz
Poland 33003 Gdansk
Poland 33018 Lublin
Poland 33013 Szczecin
Poland 33007 Warsaw
Poland 33009 Warszawa
Russian Federation 34017 Lipetsk
Russian Federation 34006 Moscow
Russian Federation 34016 Nizhny Novgorod
Russian Federation 34001 St. Petersburg
Russian Federation 34005 St. Petersburg
Russian Federation 34007 St. Petersburg
Russian Federation 34013 St. Petersburg
Serbia 35001 Belgrade
Serbia 35002 Belgrade
Serbia 35004 Belgrade
Singapore 36002 Singapore
Slovenia 38001 Celje
Slovenia 38003 Ljubljana
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 39013 Johannesburg Gauteng
South Africa 39008 Midrand
South Africa 39004 PORT Elisabeth
South Africa 39006 Pretoria
South Africa 39009 Pretoria
South Africa 39014 Pretoria
South Africa 39019 Pretoria
Spain 40009 Barcelona
Ukraine 43008 Dniepropetrovsk
Ukraine 43003 Lviv
Ukraine 43006 Odessa
United States 45035 Berlin New Jersey
United States 45102 Birmingham Alabama
United States 45134 Charlottesville Virginia
United States 45033 Chevy Chase Maryland
United States 45016 Chicago Illinois
United States 45078 Christiansburg Virginia
United States 45081 Cincinnati Ohio
United States 45091 Cincinnati Ohio
United States 45130 Colorado Springs Colorado
United States 45054 Dayton Ohio
United States 45094 Gainesville Florida
United States 45113 Germantown Tennessee
United States 45009 Great Neck New York
United States 45145 Greenville North Carolina
United States 45093 Hershey Pennsylvania
United States 45005 Hialeah Florida
United States 45067 High Point North Carolina
United States 45022 Houston Texas
United States 45028 Huntsville Alabama
United States 45037 Indianapolis Indiana
United States 45108 Jefferson City Missouri
United States 45013 Laurel Maryland
United States 45019 Lexington Kentucky
United States 45044 Little Rock Arkansas
United States 45025 Mayfield Heights Ohio
United States 45087 Miami Florida
United States 45119 Nashville Tennessee
United States 45070 New York New York
United States 45109 Norfolk Virginia
United States 45004 North Miami Beach Florida
United States 45039 Oklahoma City Oklahoma
United States 45095 Orange California
United States 45003 Raleigh North Carolina
United States 45083 Rochester Minnesota
United States 45139 Salt Lake City Utah
United States 45073 San Antonio Texas
United States 45101 San Francisco California
United States 45141 Seattle Washington
United States 45052 South Ogden Utah
United States 45041 Tulsa Oklahoma
United States 45040 Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma SA

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belarus,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Estonia,  Germany,  Hungary,  Israel,  Italy,  New Zealand,  Norway,  Poland,  Russian Federation,  Serbia,  Singapore,  Slovenia,  South Africa,  Spain,  Ukraine, 

References & Publications (1)

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. 2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
Primary Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months) An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event. Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
Secondary Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI = 4) at Study Completion Visit or (Early) Withdrawal Visit HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Secondary Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change = 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032 Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)
Secondary Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change = 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day. From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)
Secondary Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Secondary Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL. From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)
Secondary C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Secondary Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256 Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256
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