Back to resultsA follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease (PRECiSE 4)
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol (CDP870)
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
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): At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870 032 [NCT00152425] responders) OR 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
Sites / Locations
- 45102
- 45028
- 45044
- 45095
- 45101
- 45130
- 45094
- 45005
- 45087
- 45004
- 45016
- 45037
- 45019
- 45033
- 45013
- 45083
- 45108
- 45035
- 45009
- 45070
- 45145
- 45067
- 45003
- 45040
- 45081
- 45091
- 45054
- 45025
- 45039
- 45041
- 45093
- 45113
- 45119
- 45022
- 45073
- 45139
- 45052
- 45134
- 45078
- 45109
- 45141
- 11011
- 11005
- 11017
- 11006
- 11014
- 11016
- 11007
- 11002
- 11013
- 11012
- 11009
- 11010
- 11015
- 11018
- 46006
- 46003
- 46002
- 12001
- 13004
- 13001
- 13003
- 15001
- 16005
- 16014
- 16013
- 16008
- 18006
- 18001
- 18004
- 18002
- 19004
- 19009
- 19010
- 19007
- 19003
- 20001
- 20002
- 22002
- 22009
- 22004
- 22019
- 22013
- 22017
- 22015
- 22016
- 22001
- 22012
- 22008
- 24002
- 24009
- 24011
- 26004
- 26007
- 26005
- 27001
- 27004
- 27007
- 31002
- 31001
- 31005
- 31004
- 31003
- 32005
- 32008
- 32004
- 33008
- 33003
- 33018
- 33013
- 33007
- 33009
- 34017
- 34006
- 34016
- 34001
- 34005
- 34007
- 34013
- 35001
- 35002
- 35004
- 36002
- 38001
- 38003
- 39013
- 39003
- 39016
- 39018
- 39012
- 39010
- 39008
- 39004
- 39006
- 39009
- 39014
- 39019
- 40009
- 43008
- 43003
- 43006
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Certolizumab Pegol
Arm Description
3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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 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.
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00160706
Brief Title
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
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Certolizumab Pegol
Arm Type
Experimental
Arm Description
3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
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 Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
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 This Study CDP870-034 (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 362 ) and the Safety Follow-up (Week 372)
Title
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (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 362 ) and the Safety Follow-up (Week 372)
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 362) / (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 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)
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 CDP870-034
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 CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)
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 362) / (Early) Withdrawal Visit
Title
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
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] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)
Title
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Time Frame
Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Title
Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256
Time Frame
Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256
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 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):
At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870 032 [NCT00152425] responders) OR
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
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
45044
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
45095
City
Orange
State/Province
California
Country
United States
Facility Name
45101
City
San Francisco
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
45005
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
45087
City
Miami
State/Province
Florida
Country
United States
Facility Name
45004
City
North Miami Beach
State/Province
Florida
Country
United States
Facility Name
45016
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
45037
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
45019
City
Lexington
State/Province
Kentucky
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
45083
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
45108
City
Jefferson City
State/Province
Missouri
Country
United States
Facility Name
45035
City
Berlin
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
45145
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
45067
City
High Point
State/Province
North Carolina
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
45025
City
Mayfield Heights
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
45093
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
45113
City
Germantown
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
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
45134
City
Charlottesville
State/Province
Virginia
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
45141
City
Seattle
State/Province
Washington
Country
United States
Facility Name
11011
City
Bankstown
State/Province
New South Wales
Country
Australia
Facility Name
11005
City
New Lambton
State/Province
New South Wales
Country
Australia
Facility Name
11017
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
11006
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
11014
City
Lauceston
State/Province
Tasmania
Country
Australia
Facility Name
11016
City
Ballarat
State/Province
Victoria
Country
Australia
Facility Name
11007
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
11002
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
11013
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
11012
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
11009
City
Adelaide
Country
Australia
Facility Name
11010
City
Fremantle
Country
Australia
Facility Name
11015
City
Garran
Country
Australia
Facility Name
11018
City
Newtown
Country
Australia
Facility Name
46006
City
Linz
Country
Austria
Facility Name
46003
City
Salzburg
Country
Austria
Facility Name
46002
City
Wien
Country
Austria
Facility Name
12001
City
Minsk
Country
Belarus
Facility Name
13004
City
Brussels
Country
Belgium
Facility Name
13001
City
Gent
Country
Belgium
Facility Name
13003
City
Leuven
Country
Belgium
Facility Name
15001
City
Sofia
Country
Bulgaria
Facility Name
16005
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
16014
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
16013
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
16008
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
18006
City
Hradek Kralove
Country
Czechia
Facility Name
18001
City
Ostrava
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
19009
City
Copenhagen
Country
Denmark
Facility Name
19010
City
Herlev
Country
Denmark
Facility Name
19007
City
Hvidovre
Country
Denmark
Facility Name
19003
City
Vejle
Country
Denmark
Facility Name
20001
City
Tallin
Country
Estonia
Facility Name
20002
City
Tartu
Country
Estonia
Facility Name
22002
City
Berlin
Country
Germany
Facility Name
22009
City
Berlin
Country
Germany
Facility Name
22004
City
Celle
Country
Germany
Facility Name
22019
City
Frankfurt
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
22016
City
Leipzig
Country
Germany
Facility Name
22001
City
Minden
Country
Germany
Facility Name
22012
City
Munich
Country
Germany
Facility Name
22008
City
Münster
Country
Germany
Facility Name
24002
City
Budapest
Country
Hungary
Facility Name
24009
City
Pecs
Country
Hungary
Facility Name
24011
City
Szekszard
Country
Hungary
Facility Name
26004
City
Beer Sheva
Country
Israel
Facility Name
26007
City
Haifa
Country
Israel
Facility Name
26005
City
Petha Tikva
Country
Israel
Facility Name
27001
City
Milano
Country
Italy
Facility Name
27004
City
Palermo
Country
Italy
Facility Name
27007
City
Roma
Country
Italy
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
31004
City
Milford
Country
New Zealand
Facility Name
31003
City
Tauranga
Country
New Zealand
Facility Name
32005
City
Oslo
Country
Norway
Facility Name
32008
City
Oslo
Country
Norway
Facility Name
32004
City
Tromso
Country
Norway
Facility Name
33008
City
Bydgoszcz
Country
Poland
Facility Name
33003
City
Gdansk
Country
Poland
Facility Name
33018
City
Lublin
Country
Poland
Facility Name
33013
City
Szczecin
Country
Poland
Facility Name
33007
City
Warsaw
Country
Poland
Facility Name
33009
City
Warszawa
Country
Poland
Facility Name
34017
City
Lipetsk
Country
Russian Federation
Facility Name
34006
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
35001
City
Belgrade
Country
Serbia
Facility Name
35002
City
Belgrade
Country
Serbia
Facility Name
35004
City
Belgrade
Country
Serbia
Facility Name
36002
City
Singapore
Country
Singapore
Facility Name
38001
City
Celje
Country
Slovenia
Facility Name
38003
City
Ljubljana
Country
Slovenia
Facility Name
39013
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
39003
City
Cape Town
State/Province
Somerset West
Country
South Africa
Facility Name
39016
City
Cape Town
Country
South Africa
Facility Name
39018
City
Cape Town
Country
South Africa
Facility Name
39012
City
Goodwood
Country
South Africa
Facility Name
39010
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
39009
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
43008
City
Dniepropetrovsk
Country
Ukraine
Facility Name
43003
City
Lviv
Country
Ukraine
Facility Name
43006
City
Odessa
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
20363366
Citation
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. 2010 Aug;8(8):696-702.e1. doi: 10.1016/j.cgh.2010.03.024. Epub 2010 Apr 2.
Results Reference
result
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 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
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