Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00160524




Registration number
NCT00160524
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
1/08/2018

Titles & IDs
Public title
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]
Scientific 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
Secondary ID [1] 0 0
2005-002622-60
Secondary ID [2] 0 0
C87033
Universal Trial Number (UTN)
Trial acronym
PRECiSE 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Certolizumab Pegol (CDP870)

Experimental: Certolizumab Pegol - 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)
Timepoint [1] 0 0
Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
Primary outcome [2] 0 0
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)
Timepoint [2] 0 0
Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
Secondary outcome [1] 0 0
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI = 4) at Study Completion Visit or (Early) Withdrawal Visit
Timepoint [1] 0 0
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
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 outcome [3] 0 0
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
Timepoint [3] 0 0
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
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 outcome [5] 0 0
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Timepoint [5] 0 0
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Secondary outcome [6] 0 0
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
Timepoint [6] 0 0
Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
596
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
11001 - Adelaide
Recruitment hospital [2] 0 0
11016 - Ballarat
Recruitment hospital [3] 0 0
11011 - Bankstown
Recruitment hospital [4] 0 0
11007 - Box Hill
Recruitment hospital [5] 0 0
11013 - Frankston
Recruitment hospital [6] 0 0
11010 - Fremantle
Recruitment hospital [7] 0 0
11015 - Garran
Recruitment hospital [8] 0 0
11017 - Herston
Recruitment hospital [9] 0 0
11014 - Lauceston
Recruitment hospital [10] 0 0
11003 - Melbourne
Recruitment hospital [11] 0 0
11004 - Melbourne
Recruitment hospital [12] 0 0
11005 - New Lambton
Recruitment hospital [13] 0 0
11018 - Newtown
Recruitment hospital [14] 0 0
11012 - Parkville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Bankstown
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- Frankston
Recruitment postcode(s) [6] 0 0
- Fremantle
Recruitment postcode(s) [7] 0 0
- Garran
Recruitment postcode(s) [8] 0 0
- Herston
Recruitment postcode(s) [9] 0 0
- Lauceston
Recruitment postcode(s) [10] 0 0
- Melbourne
Recruitment postcode(s) [11] 0 0
- New Lambton
Recruitment postcode(s) [12] 0 0
- Newtown
Recruitment postcode(s) [13] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Austria
State/province [24] 0 0
Graz
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Belarus
State/province [27] 0 0
Minsk
Country [28] 0 0
Belarus
State/province [28] 0 0
Vitebsk
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussels
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Liege
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Canada
State/province [33] 0 0
Halifax
Country [34] 0 0
Canada
State/province [34] 0 0
Ottawa
Country [35] 0 0
Canada
State/province [35] 0 0
Toronto
Country [36] 0 0
Canada
State/province [36] 0 0
Vancouver
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Ceske Budejovice
Country [39] 0 0
Czechia
State/province [39] 0 0
Hradek Kralove
Country [40] 0 0
Czechia
State/province [40] 0 0
Melnik
Country [41] 0 0
Czechia
State/province [41] 0 0
Olomouc
Country [42] 0 0
Czechia
State/province [42] 0 0
Pardubice
Country [43] 0 0
Czechia
State/province [43] 0 0
Plzen - Lochotin
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 10
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 2
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 4
Country [47] 0 0
Denmark
State/province [47] 0 0
Aalborg
Country [48] 0 0
Denmark
State/province [48] 0 0
Aarhus
Country [49] 0 0
Denmark
State/province [49] 0 0
Copenhagen
Country [50] 0 0
Denmark
State/province [50] 0 0
Glostrup
Country [51] 0 0
Denmark
State/province [51] 0 0
Herlev
Country [52] 0 0
Denmark
State/province [52] 0 0
Hvidovre
Country [53] 0 0
Denmark
State/province [53] 0 0
Odense C
Country [54] 0 0
Estonia
State/province [54] 0 0
Tallin
Country [55] 0 0
Estonia
State/province [55] 0 0
Tartu
Country [56] 0 0
Georgia
State/province [56] 0 0
Tbilisi
Country [57] 0 0
Germany
State/province [57] 0 0
Berlin
Country [58] 0 0
Germany
State/province [58] 0 0
Cologne
Country [59] 0 0
Germany
State/province [59] 0 0
Dresden
Country [60] 0 0
Germany
State/province [60] 0 0
Göttingen
Country [61] 0 0
Germany
State/province [61] 0 0
Hannover
Country [62] 0 0
Germany
State/province [62] 0 0
Kiel
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Magdeburg
Country [65] 0 0
Germany
State/province [65] 0 0
Minden
Country [66] 0 0
Germany
State/province [66] 0 0
Münster
Country [67] 0 0
Germany
State/province [67] 0 0
Wilhelmshaven
Country [68] 0 0
Hong Kong
State/province [68] 0 0
Shatin
Country [69] 0 0
Hungary
State/province [69] 0 0
Budapest
Country [70] 0 0
Hungary
State/province [70] 0 0
Debrecen
Country [71] 0 0
Hungary
State/province [71] 0 0
Dunaujvaros
Country [72] 0 0
Hungary
State/province [72] 0 0
Gyor
Country [73] 0 0
Hungary
State/province [73] 0 0
Gyula
Country [74] 0 0
Hungary
State/province [74] 0 0
Pecs
Country [75] 0 0
Hungary
State/province [75] 0 0
Szeged
Country [76] 0 0
Hungary
State/province [76] 0 0
Szekszard
Country [77] 0 0
Hungary
State/province [77] 0 0
Veszprem
Country [78] 0 0
Israel
State/province [78] 0 0
Beer Sheva
Country [79] 0 0
Israel
State/province [79] 0 0
Haifa
Country [80] 0 0
Israel
State/province [80] 0 0
Jerusalem
Country [81] 0 0
Italy
State/province [81] 0 0
Bologna
Country [82] 0 0
Italy
State/province [82] 0 0
Milano
Country [83] 0 0
Italy
State/province [83] 0 0
Palermo
Country [84] 0 0
Italy
State/province [84] 0 0
Roma
Country [85] 0 0
Latvia
State/province [85] 0 0
Riga
Country [86] 0 0
Lithuania
State/province [86] 0 0
Kaunas
Country [87] 0 0
New Zealand
State/province [87] 0 0
Auckland
Country [88] 0 0
New Zealand
State/province [88] 0 0
Christchurch
Country [89] 0 0
New Zealand
State/province [89] 0 0
Hamilton
Country [90] 0 0
New Zealand
State/province [90] 0 0
Tauranga
Country [91] 0 0
Norway
State/province [91] 0 0
Hamar
Country [92] 0 0
Norway
State/province [92] 0 0
Haugesund
Country [93] 0 0
Norway
State/province [93] 0 0
Oslo
Country [94] 0 0
Norway
State/province [94] 0 0
Tromso
Country [95] 0 0
Poland
State/province [95] 0 0
Bialystok
Country [96] 0 0
Poland
State/province [96] 0 0
Bydgoszcz
Country [97] 0 0
Poland
State/province [97] 0 0
Cracow
Country [98] 0 0
Poland
State/province [98] 0 0
Krakow
Country [99] 0 0
Poland
State/province [99] 0 0
Lodz
Country [100] 0 0
Poland
State/province [100] 0 0
Lublin
Country [101] 0 0
Poland
State/province [101] 0 0
Opole
Country [102] 0 0
Poland
State/province [102] 0 0
Sopot
Country [103] 0 0
Poland
State/province [103] 0 0
Szczecin
Country [104] 0 0
Poland
State/province [104] 0 0
Warsaw
Country [105] 0 0
Poland
State/province [105] 0 0
Warszawa
Country [106] 0 0
Poland
State/province [106] 0 0
Wroclaw
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Lipetsk
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Moscow
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Nizhny Novgorod
Country [110] 0 0
Russian Federation
State/province [110] 0 0
St. Petersburg
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Volgograd
Country [112] 0 0
Serbia
State/province [112] 0 0
Belgrade
Country [113] 0 0
Serbia
State/province [113] 0 0
Nis
Country [114] 0 0
Singapore
State/province [114] 0 0
Singapore
Country [115] 0 0
Slovenia
State/province [115] 0 0
Celje
Country [116] 0 0
Slovenia
State/province [116] 0 0
Ljubljana
Country [117] 0 0
Slovenia
State/province [117] 0 0
Novo Mesto
Country [118] 0 0
South Africa
State/province [118] 0 0
Cape Town
Country [119] 0 0
South Africa
State/province [119] 0 0
Durban
Country [120] 0 0
South Africa
State/province [120] 0 0
Goodwood
Country [121] 0 0
South Africa
State/province [121] 0 0
Johannesburg
Country [122] 0 0
South Africa
State/province [122] 0 0
Midrand
Country [123] 0 0
South Africa
State/province [123] 0 0
PORT Elisabeth
Country [124] 0 0
South Africa
State/province [124] 0 0
Pretoria
Country [125] 0 0
Spain
State/province [125] 0 0
Barcelona
Country [126] 0 0
Sweden
State/province [126] 0 0
Stockholm
Country [127] 0 0
Sweden
State/province [127] 0 0
Umea
Country [128] 0 0
Ukraine
State/province [128] 0 0
Crimean Autonomy
Country [129] 0 0
Ukraine
State/province [129] 0 0
Dniepropetrovsk
Country [130] 0 0
Ukraine
State/province [130] 0 0
Donetsk
Country [131] 0 0
Ukraine
State/province [131] 0 0
Kharkov
Country [132] 0 0
Ukraine
State/province [132] 0 0
Kiev
Country [133] 0 0
Ukraine
State/province [133] 0 0
Lviv
Country [134] 0 0
Ukraine
State/province [134] 0 0
Odessa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00160524