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Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease (Welcome2)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab pegol (CDP870)
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, Certolizumab pegol, CDP870, Cimzia

Eligibility Criteria

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

Inclusion Criteria: Patients having completed study C87042 [NCT00308581] (previously treated with infliximab) Exclusion Criteria: Subject withdraw from C87042 [NCT00308581] study Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Certolizumab pegol 400 mg

Arm Description

400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks

Outcomes

Primary Outcome Measures

Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.

Secondary Outcome Measures

Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit.
Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects achieving clinical response at Last visit.
Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in remission at Last visit.
Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).
Occurrence of at Least 1 Hospital Stay During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.
Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.
Length of Hospital Stays During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Length of Hospital Stays During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection.
Length of Hospital Stays During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.
Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.
Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.
Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.
Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.
Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.
Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.
Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.
Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.

Full Information

First Posted
June 2, 2006
Last Updated
July 10, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00333788
Brief Title
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
Acronym
Welcome2
Official Title
Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (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
The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.

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, Certolizumab pegol, CDP870, Cimzia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab pegol 400 mg
Arm Type
Experimental
Arm Description
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Intervention Type
Biological
Intervention Name(s)
Certolizumab pegol (CDP870)
Other Intervention Name(s)
CDP870, Cimzia
Intervention Description
400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
Primary Outcome Measure Information:
Title
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Description
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
Time Frame
Maximum 164 weeks
Secondary Outcome Measure Information:
Title
Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).
Description
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit.
Time Frame
Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Title
Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Description
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects achieving clinical response at Last visit.
Time Frame
Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Title
Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Description
Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in remission at Last visit.
Time Frame
Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Title
Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Description
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Time Frame
Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Title
Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Description
Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).
Time Frame
Maximum 154 weeks
Title
Occurrence of at Least 1 Hospital Stay During the Treatment Period
Description
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.
Time Frame
Maximum 152 weeks
Title
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Description
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.
Time Frame
Maximum 12 weeks
Title
Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Description
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.
Time Frame
Maximum 164 weeks
Title
Length of Hospital Stays During the Treatment Period
Description
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Time Frame
Maximum 152 weeks
Title
Length of Hospital Stays During the Follow-Up Period
Description
Follow-up period starts the day after the last injection up to 84 days after last injection.
Time Frame
Maximum 12 weeks
Title
Length of Hospital Stays During the Overall Period
Description
Overall period corresponds to both treatment and follow-up periods in C87046.
Time Frame
Maximum 164 weeks
Title
Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
Description
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.
Time Frame
Maximum 152 weeks
Title
Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Description
Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.
Time Frame
Maximum 12 weeks
Title
Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Description
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.
Time Frame
Maximum 164 weeks
Title
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
Description
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.
Time Frame
Maximum 152 weeks
Title
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Description
Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.
Time Frame
Maximum 12 weeks
Title
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Description
Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.
Time Frame
Maximum 164 weeks
Title
Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
Description
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.
Time Frame
Maximum 152 weeks
Title
Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Description
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.
Time Frame
Maximum 12 weeks
Title
Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Description
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.
Time Frame
Maximum 164 weeks
Title
Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
Description
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.
Time Frame
Maximum 152 weeks
Title
Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Description
Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.
Time Frame
Maximum 12 weeks
Title
Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Description
Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.
Time Frame
Maximum 164 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients having completed study C87042 [NCT00308581] (previously treated with infliximab) Exclusion Criteria: Subject withdraw from C87042 [NCT00308581] study Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration
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:
City
Gainesville
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
New York
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charleston
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Innsbruck
Country
Austria
City
Wien
Country
Austria
City
Bonheiden
Country
Belgium
City
Brussels
Country
Belgium
City
Genk
Country
Belgium
City
Gent
Country
Belgium
City
Leuven
Country
Belgium
City
Liege
Country
Belgium
City
Roeselare
Country
Belgium
City
Edmonton
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Calgary
Country
Canada
City
Clichy
Country
France
City
Lille
Country
France
City
Nice Cedex 3
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Berlin
Country
Germany
City
Hamburg
Country
Germany
City
Herne
Country
Germany
City
Kiel
Country
Germany
City
Leipzig
Country
Germany
City
Minden
Country
Germany
City
Munich
Country
Germany
City
München
Country
Germany
City
Bologna
Country
Italy
City
Milano
Country
Italy
City
Padova
Country
Italy
City
Palermo
Country
Italy
City
Roma
Country
Italy
City
Torino
Country
Italy
City
Eindhoven
Country
Netherlands
City
Heerlen
Country
Netherlands
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Sevilla
Country
Spain
City
Valencia
Country
Spain
City
Stockholm
Country
Sweden
City
Bern
Country
Switzerland
City
Lausanne
Country
Switzerland
City
Bristol
Country
United Kingdom
City
London
Country
United Kingdom
City
Oxford
Country
United Kingdom

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

Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

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