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]
PRECiSE 3
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
2 other identifiers
interventional
596
25 countries
184
Brief 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 \[NCT00152425\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2004
Longer than P75 for phase_3
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
October 10, 2013
CompletedAugust 1, 2018
August 1, 2013
8.1 years
September 8, 2005
August 2, 2013
July 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (6)
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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
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
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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
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)
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
- +1 more secondary outcomes
Study Arms (1)
Certolizumab Pegol
EXPERIMENTAL400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma SAlead
Study Sites (206)
45102
Birmingham, Alabama, United States
45028
Huntsville, Alabama, United States
45144
Tucson, Arizona, United States
45095
Orange, California, United States
45006
San Diego, California, United States
45131
San Diego, California, United States
45130
Colorado Springs, Colorado, United States
45094
Gainesville, Florida, United States
45029
Jacksonville, Florida, United States
45087
Miami, Florida, United States
45085
Plantation, Florida, United States
45143
Atlanta, Georgia, United States
45064
Savannah, Georgia, United States
45138
Columbus, Indiana, United States
45111
Louisville, Kentucky, United States
45105
Annapolis, Maryland, United States
45033
Chevy Chase, Maryland, United States
45013
Laurel, Maryland, United States
45057
Plymouth, Minnesota, United States
45108
Jefferson City, Missouri, United States
45031
Lincoln, Nebraska, United States
45035
Berlin, New Jersey, United States
45124
Florham Park, New Jersey, United States
45018
New Brunswick, New Jersey, United States
45009
Great Neck, New York, United States
45070
New York, New York, United States
45117
Rochester, New York, 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
45039
Oklahoma City, Oklahoma, United States
45041
Tulsa, Oklahoma, United States
45048
Portland, Oregon, United States
45084
Chattanooga, Tennessee, United States
45113
Germantown, Tennessee, United States
45071
Nashville, Tennessee, United States
45119
Nashville, Tennessee, United States
45022
Houston, Texas, United States
45073
San Antonio, Texas, United States
45020
Salt Lake City, Utah, United States
45139
Salt Lake City, Utah, United States
45052
South Ogden, Utah, United States
45078
Christiansburg, Virginia, United States
45109
Norfolk, Virginia, United States
45135
Tacoma, Washington, United States
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, Australia
46005
Graz, Austria
46006
Linz, Austria
46002
Vienna, Austria
12001
Minsk, Belarus
12003
Minsk, Belarus
12002
Vitebsk, Belarus
13004
Brussels, Belgium
13001
Ghent, Belgium
13002
Liège, Belgium
15001
Sofia, Bulgaria
15002
Sofia, Bulgaria
16014
Halifax, Canada
16021
Ottawa, Canada
16013
Toronto, Canada
16001
Vancouver, Canada
16010
Vancouver, Canada
18003
Brno, Czechia
18011
České Budějovice, Czechia
18006
Hradek Kralove, Czechia
18009
Mělník, Czechia
18007
Olomouc, Czechia
18008
Olomouc, Czechia
18010
Pardubice, Czechia
18005
Plzen - Lochotin, Czechia
18002
Prague, Czechia
18004
Prague, Czechia
18012
Prague, Czechia
19004
Aalborg, Denmark
19002
Aarhus, Denmark
19008
Copenhagen, Denmark
19009
Copenhagen, Denmark
19001
Glostrup Municipality, Denmark
19010
Herlev, Denmark
19007
Hvidovre, Denmark
19005
Odense C, Denmark
20001
Tallinn, Estonia
20002
Tartu, Estonia
48001
Tbilisi, Georgia
22002
Berlin, Germany
22006
Berlin, Germany
22009
Berlin, Germany
22021
Cologne, Germany
22026
Dresden, Germany
22013
Göttingen, Germany
22017
Hanover, Germany
22015
Kiel, Germany
22024
Leipzig, Germany
22003
Magdeburg, Germany
22001
Minden, Germany
22008
Münster, Germany
22005
Wilhelmshaven, Germany
23002
Shatin, Hong Kong
24002
Budapest, Hungary
24012
Budapest, Hungary
24015
Budapest, Hungary
24001
Debrecen, Hungary
24014
Dunaújváros, Hungary
24010
Győr, Hungary
24005
Gyula, Hungary
24009
Pécs, Hungary
24008
Szeged, Hungary
24011
Szekszárd, Hungary
24007
Veszprém, Hungary
26004
Beersheba, Israel
26007
Haifa, Israel
26006
Jerusalem, Israel
27002
Bologna, Italy
27001
Milan, Italy
27004
Palermo, Italy
27006
Roma, Italy
27007
Roma, Italy
28001
Riga, Latvia
28003
Riga, Latvia
29001
Kaunas, Lithuania
31002
Auckland, New Zealand
31001
Christchurch, New Zealand
31005
Hamilton, New Zealand
31003
Tauranga, New Zealand
31004
Tauranga, New Zealand
32009
Hamar, Norway
32001
Haugesund, Norway
32005
Oslo, Norway
32008
Oslo, Norway
32004
Tromsø, Norway
33022
Bialystok, Poland
33004
Bydgoszcz, Poland
33002
Krakow, Poland
33010
Krakow, Poland
33011
Lodz, Poland
33012
Lodz, Poland
33019
Lublin, Poland
33020
Opole, Poland
33003
Sopot, Poland
33013
Szczecin, Poland
33001
Warsaw, Poland
33007
Warsaw, Poland
33009
Warsaw, Poland
33016
Warsaw, Poland
33006
Wroclaw, Poland
33021
Wroclaw, Poland
34017
Lipetsk, Russia
34006
Moscow, Russia
34015
Moscow, Russia
34016
Nizhny Novgorod, Russia
34001
Saint Petersburg, Russia
34005
Saint Petersburg, Russia
34007
Saint Petersburg, Russia
34013
Saint Petersburg, Russia
34008
Volgograd, Russia
35001
Belgrade, Serbia
35002
Belgrade, Serbia
35004
Belgrade, Serbia
35005
Belgrade, Serbia
35003
Niš, Serbia
36001
Singapore, Singapore
36002
Singapore, Singapore
38001
Celje, Slovenia
38003
Ljubljana, Slovenia
38004
Novo Mesto, Slovenia
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 Elizabeth, South Africa
39006
Pretoria, South Africa
39014
Pretoria, South Africa
39019
Pretoria, South Africa
40009
Barcelona, Spain
41001
Stockholm, Sweden
41004
Stockholm, Sweden
41002
Umeå, Sweden
43005
Crimean Autonomy, Ukraine
43002
Dniepropetrovsk, Ukraine
43008
Dniepropetrovsk, Ukraine
43004
Donetsk, Ukraine
43001
Kharkiv, Ukraine
43007
Kiev, Ukraine
43003
Lviv, Ukraine
43006
Odesa, Ukraine
Related Publications (3)
Lichtenstein GR, Thomsen OO, 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.
PMID: 20117244BACKGROUNDSandborn WJ, Wolf DC, Kosutic G, Parker G, Schreiber S, Lee SD, Abraham B, Afzali A, Arsenescu RI, Gutierrez A, Spearman M, Coarse J, Feagan BG. Effects of Transient and Persistent Anti-drug Antibodies to Certolizumab Pegol: Longitudinal Data from a 7-Year Study in Crohn's Disease. Inflamm Bowel Dis. 2017 Jul;23(7):1047-1056. doi: 10.1097/MIB.0000000000001100.
PMID: 28410341DERIVEDMelmed GY, McGovern D, Schreiber S, Kosutic G, Spearman M, Coarse J, Sandborn WJ. Early remission status predicts long-term outcomes in patients with Crohn's disease treated with certolizumab pegol. Curr Med Res Opin. 2016 Dec;32(12):1937-1941. doi: 10.1080/03007995.2016.1221802. Epub 2016 Aug 22.
PMID: 27494777DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
July 1, 2004
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
August 1, 2018
Results First Posted
October 10, 2013
Record last verified: 2013-08