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NCT00160524 Clinical Trial

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]

Crohn's Disease Clinical Trial

— PRECiSE 3  

Official title:
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00160524
Other study ID # C87033
Secondary ID 2005-002622-60
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2004
Est. completion date August 2012

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

Clinical Trial Summary

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]).

Recruitment information / eligibility
Status Completed
Enrollment 596
Est. completion date August 2012
Est. primary completion date August 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 trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study

- 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 criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Certolizumab Pegol (CDP870)
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Locations
Country Name City State
Australia 11001 Adelaide
Australia 11016 Ballarat
Australia 11011 Bankstown
Australia 11007 Box Hill
Australia 11013 Frankston
Australia 11010 Fremantle
Australia 11015 Garran
Australia 11017 Herston
Australia 11014 Lauceston
Australia 11003 Melbourne
Australia 11004 Melbourne
Australia 11005 New Lambton
Australia 11018 Newtown
Australia 11012 Parkville
Austria 46005 Graz
Austria 46006 Linz
Austria 46002 Wien
Belarus 12001 Minsk
Belarus 12003 Minsk
Belarus 12002 Vitebsk
Belgium 13004 Brussels
Belgium 13001 Gent
Belgium 13002 Liege
Bulgaria 15001 Sofia
Bulgaria 15002 Sofia
Canada 16014 Halifax
Canada 16021 Ottawa
Canada 16013 Toronto
Canada 16001 Vancouver
Canada 16010 Vancouver
Czechia 18003 Brno
Czechia 18011 Ceske Budejovice
Czechia 18006 Hradek Kralove
Czechia 18009 Melnik
Czechia 18007 Olomouc
Czechia 18008 Olomouc
Czechia 18010 Pardubice
Czechia 18005 Plzen - Lochotin
Czechia 18012 Praha 10
Czechia 18004 Praha 2
Czechia 18002 Praha 4
Denmark 19004 Aalborg
Denmark 19002 Aarhus
Denmark 19008 Copenhagen
Denmark 19009 Copenhagen
Denmark 19001 Glostrup
Denmark 19010 Herlev
Denmark 19007 Hvidovre
Denmark 19005 Odense C
Estonia 20001 Tallin
Estonia 20002 Tartu
Georgia 48001 Tbilisi
Germany 22002 Berlin
Germany 22006 Berlin
Germany 22009 Berlin
Germany 22021 Cologne
Germany 22026 Dresden
Germany 22013 Göttingen
Germany 22017 Hannover
Germany 22015 Kiel
Germany 22024 Leipzig
Germany 22003 Magdeburg
Germany 22001 Minden
Germany 22008 Münster
Germany 22005 Wilhelmshaven
Hong Kong 23002 Shatin
Hungary 24002 Budapest
Hungary 24012 Budapest
Hungary 24015 Budapest
Hungary 24001 Debrecen
Hungary 24014 Dunaujvaros
Hungary 24010 Gyor
Hungary 24005 Gyula
Hungary 24009 Pecs
Hungary 24008 Szeged
Hungary 24011 Szekszard
Hungary 24007 Veszprem
Israel 26004 Beer Sheva
Israel 26007 Haifa
Israel 26006 Jerusalem
Italy 27002 Bologna
Italy 27001 Milano
Italy 27004 Palermo
Italy 27006 Roma
Italy 27007 Roma
Latvia 28001 Riga
Latvia 28003 Riga
Lithuania 29001 Kaunas
New Zealand 31002 Auckland
New Zealand 31001 Christchurch
New Zealand 31005 Hamilton
New Zealand 31003 Tauranga
New Zealand 31004 Tauranga
Norway 32009 Hamar
Norway 32001 Haugesund
Norway 32005 Oslo
Norway 32008 Oslo
Norway 32004 Tromso
Poland 33022 Bialystok
Poland 33004 Bydgoszcz
Poland 33002 Cracow
Poland 33010 Krakow
Poland 33011 Lodz
Poland 33012 Lodz
Poland 33019 Lublin
Poland 33020 Opole
Poland 33003 Sopot
Poland 33013 Szczecin
Poland 33007 Warsaw
Poland 33001 Warszawa
Poland 33009 Warszawa
Poland 33016 Warszawa
Poland 33006 Wroclaw
Poland 33021 Wroclaw
Russian Federation 34017 Lipetsk
Russian Federation 34006 Moscow
Russian Federation 34015 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
Russian Federation 34008 Volgograd
Serbia 35001 Belgrade
Serbia 35002 Belgrade
Serbia 35004 Belgrade
Serbia 35005 Belgrade
Serbia 35003 Nis
Singapore 36001 Singapore
Singapore 36002 Singapore
Slovenia 38001 Celje
Slovenia 38003 Ljubljana
Slovenia 38004 Novo Mesto
South Africa 39003 Cape Town
South Africa 39016 Cape Town
South Africa 39017 Cape Town
South Africa 39011 Durban
South Africa 39012 Goodwood
South Africa 39002 Johannesburg
South Africa 39007 Johannesburg
South Africa 39010 Johannesburg
South Africa 39013 Johannesburg
South Africa 39008 Midrand
South Africa 39004 PORT Elisabeth
South Africa 39006 Pretoria
South Africa 39014 Pretoria
South Africa 39019 Pretoria
Spain 40009 Barcelona
Sweden 41001 Stockholm
Sweden 41004 Stockholm
Sweden 41002 Umea
Ukraine 43005 Crimean Autonomy
Ukraine 43002 Dniepropetrovsk
Ukraine 43008 Dniepropetrovsk
Ukraine 43004 Donetsk
Ukraine 43001 Kharkov
Ukraine 43007 Kiev
Ukraine 43003 Lviv
Ukraine 43006 Odessa
United States 45105 Annapolis Maryland
United States 45143 Atlanta Georgia
United States 45035 Berlin New Jersey
United States 45102 Birmingham Alabama
United States 45084 Chattanooga Tennessee
United States 45033 Chevy Chase Maryland
United States 45078 Christiansburg Virginia
United States 45081 Cincinnati Ohio
United States 45091 Cincinnati Ohio
United States 45130 Colorado Springs Colorado
United States 45138 Columbus Indiana
United States 45054 Dayton Ohio
United States 45124 Florham Park New Jersey
United States 45094 Gainesville Florida
United States 45113 Germantown Tennessee
United States 45009 Great Neck New York
United States 45022 Houston Texas
United States 45028 Huntsville Alabama
United States 45029 Jacksonville Florida
United States 45108 Jefferson City Missouri
United States 45013 Laurel Maryland
United States 45031 Lincoln Nebraska
United States 45111 Louisville Kentucky
United States 45087 Miami Florida
United States 45071 Nashville Tennessee
United States 45119 Nashville Tennessee
United States 45018 New Brunswick New Jersey
United States 45070 New York New York
United States 45109 Norfolk Virginia
United States 45039 Oklahoma City Oklahoma
United States 45095 Orange California
United States 45085 Plantation Florida
United States 45057 Plymouth Minnesota
United States 45048 Portland Oregon
United States 45003 Raleigh North Carolina
United States 45117 Rochester New York
United States 45020 Salt Lake City Utah
United States 45139 Salt Lake City Utah
United States 45073 San Antonio Texas
United States 45006 San Diego California
United States 45131 San Diego California
United States 45064 Savannah Georgia
United States 45052 South Ogden Utah
United States 45135 Tacoma Washington
United States 45144 Tucson Arizona
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,  Georgia,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  New Zealand,  Norway,  Poland,  Russian Federation,  Serbia,  Singapore,  Slovenia,  South Africa,  Spain,  Sweden,  Ukraine, 

References & Publications (1)

Lichtenstein GR, Thomsen OØ, Schreiber S, Lawrance IC, Hanauer SB, Bloomfield R, Sandborn WJ; Precise 3 Study Investigators. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroenterol Hepatol. 2010 Jul;8(7):600-9. doi: 10.1016/j.cgh.2010.01.014. Epub 2010 Feb 1. — 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 the Study CDP870-033 (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 364) and the Safety Follow-up (Week 374)
Primary Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (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 364) and the Safety Follow-up (Week 374)
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 364) / (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 Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit
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 364) / (Early) Withdrawal Visit
Secondary Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033 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] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)
Secondary C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Secondary Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258 Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
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