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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] (PRECiSE 3)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol (CDP870)
Sponsored by
UCB Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Certolizumab Pegol, Cimzia, CDP870, CZP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 45102
  • 45028
  • 45144
  • 45095
  • 45006
  • 45131
  • 45130
  • 45094
  • 45029
  • 45087
  • 45085
  • 45143
  • 45064
  • 45138
  • 45111
  • 45105
  • 45033
  • 45013
  • 45057
  • 45108
  • 45031
  • 45035
  • 45124
  • 45018
  • 45009
  • 45070
  • 45117
  • 45003
  • 45040
  • 45081
  • 45091
  • 45054
  • 45039
  • 45041
  • 45048
  • 45084
  • 45113
  • 45071
  • 45119
  • 45022
  • 45073
  • 45020
  • 45139
  • 45052
  • 45078
  • 45109
  • 45135
  • 11001
  • 11016
  • 11011
  • 11007
  • 11013
  • 11010
  • 11015
  • 11017
  • 11014
  • 11003
  • 11004
  • 11005
  • 11018
  • 11012
  • 46005
  • 46006
  • 46002
  • 12001
  • 12003
  • 12002
  • 13004
  • 13001
  • 13002
  • 15001
  • 15002
  • 16014
  • 16021
  • 16013
  • 16001
  • 16010
  • 18003
  • 18011
  • 18006
  • 18009
  • 18007
  • 18008
  • 18010
  • 18005
  • 18012
  • 18004
  • 18002
  • 19004
  • 19002
  • 19008
  • 19009
  • 19001
  • 19010
  • 19007
  • 19005
  • 20001
  • 20002
  • 48001
  • 22002
  • 22006
  • 22009
  • 22021
  • 22026
  • 22013
  • 22017
  • 22015
  • 22024
  • 22003
  • 22001
  • 22008
  • 22005
  • 23002
  • 24002
  • 24012
  • 24015
  • 24001
  • 24014
  • 24010
  • 24005
  • 24009
  • 24008
  • 24011
  • 24007
  • 26004
  • 26007
  • 26006
  • 27002
  • 27001
  • 27004
  • 27006
  • 27007
  • 28001
  • 28003
  • 29001
  • 31002
  • 31001
  • 31005
  • 31003
  • 31004
  • 32009
  • 32001
  • 32005
  • 32008
  • 32004
  • 33022
  • 33004
  • 33002
  • 33010
  • 33011
  • 33012
  • 33019
  • 33020
  • 33003
  • 33013
  • 33007
  • 33001
  • 33009
  • 33016
  • 33006
  • 33021
  • 34017
  • 34006
  • 34015
  • 34016
  • 34001
  • 34005
  • 34007
  • 34013
  • 34008
  • 35001
  • 35002
  • 35004
  • 35005
  • 35003
  • 36001
  • 36002
  • 38001
  • 38003
  • 38004
  • 39003
  • 39016
  • 39017
  • 39011
  • 39012
  • 39002
  • 39007
  • 39010
  • 39013
  • 39008
  • 39004
  • 39006
  • 39014
  • 39019
  • 40009
  • 41001
  • 41004
  • 41002
  • 43005
  • 43002
  • 43008
  • 43004
  • 43001
  • 43007
  • 43003
  • 43006

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Certolizumab Pegol

Arm Description

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258

Full Information

First Posted
September 8, 2005
Last Updated
July 5, 2018
Sponsor
UCB Pharma SA
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1. Study Identification

Unique Protocol Identification Number
NCT00160524
Brief 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]
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Certolizumab Pegol, Cimzia, CDP870, CZP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab Pegol
Arm Type
Experimental
Arm Description
400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol (CDP870)
Other Intervention Name(s)
Cimzia, CDP870, CZP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)
Description
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.
Time Frame
Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
Title
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)
Description
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.
Time Frame
Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
Description
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.
Time Frame
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Title
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
Description
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.
Time Frame
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
Title
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
Description
Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Time Frame
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Title
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
Description
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.
Time Frame
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)
Title
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Time Frame
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Title
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
Time Frame
Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
45102
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
45028
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
45144
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
45095
City
Orange
State/Province
California
Country
United States
Facility Name
45006
City
San Diego
State/Province
California
Country
United States
Facility Name
45131
City
San Diego
State/Province
California
Country
United States
Facility Name
45130
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
45094
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
45029
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
45087
City
Miami
State/Province
Florida
Country
United States
Facility Name
45085
City
Plantation
State/Province
Florida
Country
United States
Facility Name
45143
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
45064
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
45138
City
Columbus
State/Province
Indiana
Country
United States
Facility Name
45111
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
45105
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
45033
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
45013
City
Laurel
State/Province
Maryland
Country
United States
Facility Name
45057
City
Plymouth
State/Province
Minnesota
Country
United States
Facility Name
45108
City
Jefferson City
State/Province
Missouri
Country
United States
Facility Name
45031
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
45035
City
Berlin
State/Province
New Jersey
Country
United States
Facility Name
45124
City
Florham Park
State/Province
New Jersey
Country
United States
Facility Name
45018
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
45009
City
Great Neck
State/Province
New York
Country
United States
Facility Name
45070
City
New York
State/Province
New York
Country
United States
Facility Name
45117
City
Rochester
State/Province
New York
Country
United States
Facility Name
45003
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
45040
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
45081
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
45091
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
45054
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
45039
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
45041
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
45048
City
Portland
State/Province
Oregon
Country
United States
Facility Name
45084
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
45113
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
45071
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
45119
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
45022
City
Houston
State/Province
Texas
Country
United States
Facility Name
45073
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
45020
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
45139
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
45052
City
South Ogden
State/Province
Utah
Country
United States
Facility Name
45078
City
Christiansburg
State/Province
Virginia
Country
United States
Facility Name
45109
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
45135
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
11001
City
Adelaide
Country
Australia
Facility Name
11016
City
Ballarat
Country
Australia
Facility Name
11011
City
Bankstown
Country
Australia
Facility Name
11007
City
Box Hill
Country
Australia
Facility Name
11013
City
Frankston
Country
Australia
Facility Name
11010
City
Fremantle
Country
Australia
Facility Name
11015
City
Garran
Country
Australia
Facility Name
11017
City
Herston
Country
Australia
Facility Name
11014
City
Lauceston
Country
Australia
Facility Name
11003
City
Melbourne
Country
Australia
Facility Name
11004
City
Melbourne
Country
Australia
Facility Name
11005
City
New Lambton
Country
Australia
Facility Name
11018
City
Newtown
Country
Australia
Facility Name
11012
City
Parkville
Country
Australia
Facility Name
46005
City
Graz
Country
Austria
Facility Name
46006
City
Linz
Country
Austria
Facility Name
46002
City
Wien
Country
Austria
Facility Name
12001
City
Minsk
Country
Belarus
Facility Name
12003
City
Minsk
Country
Belarus
Facility Name
12002
City
Vitebsk
Country
Belarus
Facility Name
13004
City
Brussels
Country
Belgium
Facility Name
13001
City
Gent
Country
Belgium
Facility Name
13002
City
Liege
Country
Belgium
Facility Name
15001
City
Sofia
Country
Bulgaria
Facility Name
15002
City
Sofia
Country
Bulgaria
Facility Name
16014
City
Halifax
Country
Canada
Facility Name
16021
City
Ottawa
Country
Canada
Facility Name
16013
City
Toronto
Country
Canada
Facility Name
16001
City
Vancouver
Country
Canada
Facility Name
16010
City
Vancouver
Country
Canada
Facility Name
18003
City
Brno
Country
Czechia
Facility Name
18011
City
Ceske Budejovice
Country
Czechia
Facility Name
18006
City
Hradek Kralove
Country
Czechia
Facility Name
18009
City
Melnik
Country
Czechia
Facility Name
18007
City
Olomouc
Country
Czechia
Facility Name
18008
City
Olomouc
Country
Czechia
Facility Name
18010
City
Pardubice
Country
Czechia
Facility Name
18005
City
Plzen - Lochotin
Country
Czechia
Facility Name
18012
City
Praha 10
Country
Czechia
Facility Name
18004
City
Praha 2
Country
Czechia
Facility Name
18002
City
Praha 4
Country
Czechia
Facility Name
19004
City
Aalborg
Country
Denmark
Facility Name
19002
City
Aarhus
Country
Denmark
Facility Name
19008
City
Copenhagen
Country
Denmark
Facility Name
19009
City
Copenhagen
Country
Denmark
Facility Name
19001
City
Glostrup
Country
Denmark
Facility Name
19010
City
Herlev
Country
Denmark
Facility Name
19007
City
Hvidovre
Country
Denmark
Facility Name
19005
City
Odense C
Country
Denmark
Facility Name
20001
City
Tallin
Country
Estonia
Facility Name
20002
City
Tartu
Country
Estonia
Facility Name
48001
City
Tbilisi
Country
Georgia
Facility Name
22002
City
Berlin
Country
Germany
Facility Name
22006
City
Berlin
Country
Germany
Facility Name
22009
City
Berlin
Country
Germany
Facility Name
22021
City
Cologne
Country
Germany
Facility Name
22026
City
Dresden
Country
Germany
Facility Name
22013
City
Göttingen
Country
Germany
Facility Name
22017
City
Hannover
Country
Germany
Facility Name
22015
City
Kiel
Country
Germany
Facility Name
22024
City
Leipzig
Country
Germany
Facility Name
22003
City
Magdeburg
Country
Germany
Facility Name
22001
City
Minden
Country
Germany
Facility Name
22008
City
Münster
Country
Germany
Facility Name
22005
City
Wilhelmshaven
Country
Germany
Facility Name
23002
City
Shatin
Country
Hong Kong
Facility Name
24002
City
Budapest
Country
Hungary
Facility Name
24012
City
Budapest
Country
Hungary
Facility Name
24015
City
Budapest
Country
Hungary
Facility Name
24001
City
Debrecen
Country
Hungary
Facility Name
24014
City
Dunaujvaros
Country
Hungary
Facility Name
24010
City
Gyor
Country
Hungary
Facility Name
24005
City
Gyula
Country
Hungary
Facility Name
24009
City
Pecs
Country
Hungary
Facility Name
24008
City
Szeged
Country
Hungary
Facility Name
24011
City
Szekszard
Country
Hungary
Facility Name
24007
City
Veszprem
Country
Hungary
Facility Name
26004
City
Beer Sheva
Country
Israel
Facility Name
26007
City
Haifa
Country
Israel
Facility Name
26006
City
Jerusalem
Country
Israel
Facility Name
27002
City
Bologna
Country
Italy
Facility Name
27001
City
Milano
Country
Italy
Facility Name
27004
City
Palermo
Country
Italy
Facility Name
27006
City
Roma
Country
Italy
Facility Name
27007
City
Roma
Country
Italy
Facility Name
28001
City
Riga
Country
Latvia
Facility Name
28003
City
Riga
Country
Latvia
Facility Name
29001
City
Kaunas
Country
Lithuania
Facility Name
31002
City
Auckland
Country
New Zealand
Facility Name
31001
City
Christchurch
Country
New Zealand
Facility Name
31005
City
Hamilton
Country
New Zealand
Facility Name
31003
City
Tauranga
Country
New Zealand
Facility Name
31004
City
Tauranga
Country
New Zealand
Facility Name
32009
City
Hamar
Country
Norway
Facility Name
32001
City
Haugesund
Country
Norway
Facility Name
32005
City
Oslo
Country
Norway
Facility Name
32008
City
Oslo
Country
Norway
Facility Name
32004
City
Tromso
Country
Norway
Facility Name
33022
City
Bialystok
Country
Poland
Facility Name
33004
City
Bydgoszcz
Country
Poland
Facility Name
33002
City
Cracow
Country
Poland
Facility Name
33010
City
Krakow
Country
Poland
Facility Name
33011
City
Lodz
Country
Poland
Facility Name
33012
City
Lodz
Country
Poland
Facility Name
33019
City
Lublin
Country
Poland
Facility Name
33020
City
Opole
Country
Poland
Facility Name
33003
City
Sopot
Country
Poland
Facility Name
33013
City
Szczecin
Country
Poland
Facility Name
33007
City
Warsaw
Country
Poland
Facility Name
33001
City
Warszawa
Country
Poland
Facility Name
33009
City
Warszawa
Country
Poland
Facility Name
33016
City
Warszawa
Country
Poland
Facility Name
33006
City
Wroclaw
Country
Poland
Facility Name
33021
City
Wroclaw
Country
Poland
Facility Name
34017
City
Lipetsk
Country
Russian Federation
Facility Name
34006
City
Moscow
Country
Russian Federation
Facility Name
34015
City
Moscow
Country
Russian Federation
Facility Name
34016
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
34001
City
St. Petersburg
Country
Russian Federation
Facility Name
34005
City
St. Petersburg
Country
Russian Federation
Facility Name
34007
City
St. Petersburg
Country
Russian Federation
Facility Name
34013
City
St. Petersburg
Country
Russian Federation
Facility Name
34008
City
Volgograd
Country
Russian Federation
Facility Name
35001
City
Belgrade
Country
Serbia
Facility Name
35002
City
Belgrade
Country
Serbia
Facility Name
35004
City
Belgrade
Country
Serbia
Facility Name
35005
City
Belgrade
Country
Serbia
Facility Name
35003
City
Nis
Country
Serbia
Facility Name
36001
City
Singapore
Country
Singapore
Facility Name
36002
City
Singapore
Country
Singapore
Facility Name
38001
City
Celje
Country
Slovenia
Facility Name
38003
City
Ljubljana
Country
Slovenia
Facility Name
38004
City
Novo Mesto
Country
Slovenia
Facility Name
39003
City
Cape Town
Country
South Africa
Facility Name
39016
City
Cape Town
Country
South Africa
Facility Name
39017
City
Cape Town
Country
South Africa
Facility Name
39011
City
Durban
Country
South Africa
Facility Name
39012
City
Goodwood
Country
South Africa
Facility Name
39002
City
Johannesburg
Country
South Africa
Facility Name
39007
City
Johannesburg
Country
South Africa
Facility Name
39010
City
Johannesburg
Country
South Africa
Facility Name
39013
City
Johannesburg
Country
South Africa
Facility Name
39008
City
Midrand
Country
South Africa
Facility Name
39004
City
PORT Elisabeth
Country
South Africa
Facility Name
39006
City
Pretoria
Country
South Africa
Facility Name
39014
City
Pretoria
Country
South Africa
Facility Name
39019
City
Pretoria
Country
South Africa
Facility Name
40009
City
Barcelona
Country
Spain
Facility Name
41001
City
Stockholm
Country
Sweden
Facility Name
41004
City
Stockholm
Country
Sweden
Facility Name
41002
City
Umea
Country
Sweden
Facility Name
43005
City
Crimean Autonomy
Country
Ukraine
Facility Name
43002
City
Dniepropetrovsk
Country
Ukraine
Facility Name
43008
City
Dniepropetrovsk
Country
Ukraine
Facility Name
43004
City
Donetsk
Country
Ukraine
Facility Name
43001
City
Kharkov
Country
Ukraine
Facility Name
43007
City
Kiev
Country
Ukraine
Facility Name
43003
City
Lviv
Country
Ukraine
Facility Name
43006
City
Odessa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
20117244
Citation
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.
Results Reference
background
PubMed Identifier
28410341
Citation
Sandborn 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.
Results Reference
derived
PubMed Identifier
27494777
Citation
Melmed 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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this 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]

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