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Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Certolizumab Pegol
Placebo
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion Criteria: Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period Exclusion Criteria: Stoma patient Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody Patients who participated in a clinical study with CDP870 Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators Exclusion Criteria:

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Certolizumab pegol 200 mg

Certolizumab pegol 400 mg

Placebo

Arm Description

Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.

Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.

Secondary Outcome Measures

Crohn's Disease Activity Index (CDAI) Score at Week 2
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Crohn's Disease Activity Index (CDAI) Score at Week 4
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Crohn's Disease Activity Index (CDAI) Score at Week 6
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve CDAI Response at Week 2
CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Percentage of Subjects Who Achieve CDAI Response at Week 4
CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Concentration of C-reactive Protein (CRP) Value at Week 2
CRP data for subjects receiving rescue medication were excluded.
Concentration of C-reactive Protein (CRP) Value at Week 4
CRP data for subjects receiving rescue medication were excluded.
Concentration of C-reactive Protein (CRP) Value at Week 6
CRP data for subjects receiving rescue medication were excluded.
C-reactive Protein (CRP) Ratio to Baseline at Week 2
CRP data for subjects receiving rescue medication were excluded.
C-reactive Protein (CRP) Ratio to Baseline at Week 4
CRP data for subjects receiving rescue medication were excluded.
C-reactive Protein (CRP) Ratio to Baseline at Week 6
CRP data for subjects receiving rescue medication were excluded.

Full Information

First Posted
February 10, 2006
Last Updated
July 14, 2020
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00291668
Brief Title
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
Official Title
A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2006 (Actual)
Primary Completion Date
November 8, 2007 (Actual)
Study Completion Date
November 8, 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with 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
Keywords
Crohn's Disease, CDP870, Certolizumab pegol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab pegol 200 mg
Arm Type
Experimental
Arm Description
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
Arm Title
Certolizumab pegol 400 mg
Arm Type
Experimental
Arm Description
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol
Other Intervention Name(s)
CDP870
Intervention Description
Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Active Substance: isotonic sodium chloride solution Pharmaceutical Form: Solution for injection Concentration: 1 mL Route of Administration: Subcutaneous use
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
Description
CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Crohn's Disease Activity Index (CDAI) Score at Week 2
Description
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame
Week 2
Title
Crohn's Disease Activity Index (CDAI) Score at Week 4
Description
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame
Week 4
Title
Crohn's Disease Activity Index (CDAI) Score at Week 6
Description
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame
Week 6
Title
Percentage of Subjects Who Achieve CDAI Response at Week 2
Description
CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Time Frame
Baseline, Week 2
Title
Percentage of Subjects Who Achieve CDAI Response at Week 4
Description
CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Time Frame
Baseline, Week 4
Title
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
Description
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame
Baseline, Week 2
Title
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
Description
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame
Baseline, Week 4
Title
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
Description
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time Frame
Baseline, Week 6
Title
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
Description
Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
Time Frame
Week 2
Title
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
Description
Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
Time Frame
Week 4
Title
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
Description
Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
Time Frame
Week 6
Title
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
Description
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).
Time Frame
Baseline, Week 2
Title
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
Description
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).
Time Frame
Baseline, Week 4
Title
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
Description
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).
Time Frame
Baseline, Week 6
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
Description
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame
Week 2
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
Description
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame
Week 4
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
Description
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Time Frame
Week 6
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
Description
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame
Week 2
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
Description
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame
Week 4
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
Description
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Time Frame
Week 6
Title
Concentration of C-reactive Protein (CRP) Value at Week 2
Description
CRP data for subjects receiving rescue medication were excluded.
Time Frame
Week 2
Title
Concentration of C-reactive Protein (CRP) Value at Week 4
Description
CRP data for subjects receiving rescue medication were excluded.
Time Frame
Week 4
Title
Concentration of C-reactive Protein (CRP) Value at Week 6
Description
CRP data for subjects receiving rescue medication were excluded.
Time Frame
Week 6
Title
C-reactive Protein (CRP) Ratio to Baseline at Week 2
Description
CRP data for subjects receiving rescue medication were excluded.
Time Frame
Baseline, Week 2
Title
C-reactive Protein (CRP) Ratio to Baseline at Week 4
Description
CRP data for subjects receiving rescue medication were excluded.
Time Frame
Baseline, Week 4
Title
C-reactive Protein (CRP) Ratio to Baseline at Week 6
Description
CRP data for subjects receiving rescue medication were excluded.
Time Frame
Baseline, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period Exclusion Criteria: Stoma patient Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody Patients who participated in a clinical study with CDP870 Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators Exclusion Criteria:
Facility Information:
City
Aichi-Gun
State/Province
Aichi
Country
Japan
City
Nagoya
State/Province
Aichi
Country
Japan
City
Toyoake
State/Province
Aichi
Country
Japan
City
Toyohashi
State/Province
Aichi
Country
Japan
City
Kashiwa
State/Province
Chiba
Country
Japan
City
Sakura
State/Province
Chiba
Country
Japan
City
Chikusino
State/Province
Fukuoka
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Nishinomiya
State/Province
Hyogo
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Miyazaki-gun
State/Province
Miyazaki
Country
Japan
City
Kurashiki
State/Province
Okayama
Country
Japan
City
Tyuto-gun
State/Province
Okinawa
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Otsu
State/Province
Shiga
Country
Japan
City
Shinjyuku
State/Province
Tokyo
Country
Japan
City
Fukuoka
Country
Japan
City
Kagoshima
Country
Japan
City
Nagasaki
Country
Japan
City
Niigata
Country
Japan
City
Osaka
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

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