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Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00308581
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : November 17, 2009
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE March 28, 2006
First Posted Date  ICMJE March 29, 2006
Results First Submitted Date  ICMJE July 7, 2009
Results First Posted Date  ICMJE November 17, 2009
Last Update Posted Date August 7, 2018
Study Start Date  ICMJE April 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase [ Time Frame: Baseline to Week 6 ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2006)
Assessment of Clinical efficacy of certolizumab pegol at week 6 based on CDAI score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
  • Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 26 ]
    Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase [ Time Frame: Baseline to Week 6 ]
    Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 26 ]
    Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase [ Time Frame: Week 6 ]
    Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase [ Time Frame: Week 26 ]
    Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 2 of the Induction Phase [ Time Frame: Week 2 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 4 of the Induction Phase [ Time Frame: Week 4 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 6 of the Induction Phase [ Time Frame: Week 6 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 8 in the Randomized Maintenance Phase [ Time Frame: Week 8 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 10 in the Randomized Maintenance Phase [ Time Frame: Week 10 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 12 in the Randomized Maintenance Phase [ Time Frame: Week 12 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 14 in the Randomized Maintenance Phase [ Time Frame: Week 14 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 16 in the Randomized Maintenance Phase [ Time Frame: Week 16 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 18 in the Randomized Maintenance Phase [ Time Frame: Week 18 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 20 in the Randomized Maintenance Phase [ Time Frame: Week 20 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 22 in the Randomized Maintenance Phase [ Time Frame: Week 22 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 24 in the Randomized Maintenance Phase [ Time Frame: Week 24 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: Week 26 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 2 of the Induction Phase [ Time Frame: Baseline to Week 2 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 4 of the Induction Phase [ Time Frame: Baseline to Week 4 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 6 of the Induction Phase [ Time Frame: Baseline to Week 6 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 8 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 10 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 12 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 14 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 16 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 18 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 20 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 22 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 24 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 26 ]
    The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 10 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 12 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 14 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 16 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 18 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 20 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 22 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 24 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 26 ]
    Remission is defined as CDAI score ≤ 150.
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 10 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 12 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 14 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 16 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 18 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 20 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 22 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 24 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 26 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
  • C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase [ Time Frame: Week 0 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 2 of the Induction Phase [ Time Frame: Week 2 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 4 of the Induction Phase [ Time Frame: Week 4 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 6 of the Induction Phase [ Time Frame: Week 6 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 8 in the Randomized Maintenance Phase [ Time Frame: Week 8 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 10 in the Randomized Maintenance Phase [ Time Frame: Week 10 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 12 in the Randomized Maintenance Phase [ Time Frame: Week 12 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 14 in the Randomized Maintenance Phase [ Time Frame: Week 14 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 16 in the Randomized Maintenance Phase [ Time Frame: Week 16 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 18 in the Randomized Maintenance Phase [ Time Frame: Week 18 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 20 in the Randomized Maintenance Phase [ Time Frame: Week 20 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 22 in the Randomized Maintenance Phase [ Time Frame: Week 22 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 24 in the Randomized Maintenance Phase [ Time Frame: Week 24 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Week 26 in the Randomized Maintenance Phase [ Time Frame: Week 26 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
  • CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase [ Time Frame: Last visit on or before Week 26 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2006)
Assessment of clinical efficacy of certolizumab pegol and treatment response over 26 weeks
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2009)
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6 [ Time Frame: Week 6 to Week 26 ]
Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Official Title  ICMJE Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
Brief Summary To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Biological: Certolizumab pegol
    400mg Certolizumab Pegol, Q4W, administered 4-weekly
    Other Names:
    • CDP870
    • Cimzia
  • Biological: Certolizumab pegol
    400mg Certolizumab Pegol, Q2W, administered 2-weekly
    Other Names:
    • CDP870
    • Cimzia
  • Other: Placebo
    placebo administered 4-weekly in Active 1
Study Arms  ICMJE
  • Experimental: Active 1

    Q4W regimen

    - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol

    Interventions:
    • Biological: Certolizumab pegol
    • Other: Placebo
  • Experimental: Active 2

    Q2W regimen

    - every 2 weeks: 400 mg Certolizumab Pegol

    Intervention: Biological: Certolizumab pegol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
539
Original Enrollment  ICMJE
 (submitted: March 28, 2006)
600
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with Crohn's Disease
  • Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion Criteria:

  • Obstructive intestinal strictures
  • Recent bowel resection
  • Proctocolectomy or total colectomy
  • Current total parenteral nutrition
  • Short bowel syndrome
  • All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
  • Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00308581
Other Study ID Numbers  ICMJE C87042
Eudract number: 2005-004104-37
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP