Clinical trial NCT00333788: Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Certolizumab pegol
CDP870
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
timeFrame: Maximum 164 weeks
Secondary outcomes:
measure: 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).
timeFrame: 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]
measure: Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
timeFrame: 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]
measure: Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
timeFrame: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
measure: 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]
timeFrame: 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]
measure: Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
timeFrame: Maximum 154 weeks
measure: Occurrence of at Least 1 Hospital Stay During the Treatment Period
timeFrame: Maximum 152 weeks
measure: Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
timeFrame: Maximum 12 weeks
measure: Occurrence of at Least 1 Hospital Stay During the During the Overall Period
timeFrame: Maximum 164 weeks
measure: Length of Hospital Stays During the Treatment Period
timeFrame: Maximum 152 weeks
measure: Length of Hospital Stays During the Follow-Up Period
timeFrame: Maximum 12 weeks
measure: Length of Hospital Stays During the Overall Period
timeFrame: Maximum 164 weeks
measure: Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
timeFrame: Maximum 152 weeks
measure: Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
timeFrame: Maximum 12 weeks
measure: Occurrence of at Least 1 Emergency Room Visit During the Overall Period
timeFrame: Maximum 164 weeks
measure: Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
timeFrame: Maximum 152 weeks
measure: Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
timeFrame: Maximum 12 weeks
measure: Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
timeFrame: Maximum 164 weeks
measure: Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
timeFrame: Maximum 152 weeks
measure: Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
timeFrame: Maximum 12 weeks
measure: Occurrence of at Least 1 General Concomitant Medication During the Overall Period
timeFrame: Maximum 164 weeks
measure: Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
timeFrame: Maximum 152 weeks
measure: Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
timeFrame: Maximum 12 weeks
measure: Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
timeFrame: Maximum 164 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Lincoln
country: United States
state: Nebraska
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charleston
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
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
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
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
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: