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Completed

NCT Number: NCT00308581

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

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

Completed

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab Pegol

Biological

400mg Certolizumab Pegol, Q4W, administered 4-weekly

Other names: CDP870, Cimzia

Placebo

Other

placebo administered 4-weekly in Active 1

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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).

  42. 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).

  43. 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).

  44. 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).

  45. 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).

  46. 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).

  47. 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).

  48. 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).

  49. 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).

  50. 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.

  51. 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.

  52. 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.

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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.

  63. 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.

  64. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 29, 2006
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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