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Completed

NCT Number: NCT00291668

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

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.

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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

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi-Gun, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Certolizumab Pegol

Biological
  • Active Substance: Certolizumab Pegol
  • Pharmaceutical Form: Solution for injection in pre-filled syringe
  • Concentration: 200 mg/mL
  • Route of Administration: Subcutaneous use

Other names: CDP870

Placebo

Other
  • Active Substance: isotonic sodium chloride solution
  • Pharmaceutical Form: Solution for injection
  • Concentration: 1 mL
  • Route of Administration: Subcutaneous use

Primary outcomes

  1. Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6

    Time frame: Baseline, 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 outcomes

  1. Crohn's Disease Activity Index (CDAI) Score at Week 2

    Time frame: 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.

  2. Crohn's Disease Activity Index (CDAI) Score at Week 4

    Time frame: 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.

  3. Crohn's Disease Activity Index (CDAI) Score at Week 6

    Time frame: 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.

  4. Percentage of Subjects Who Achieve CDAI Response at Week 2

    Time frame: Baseline, 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.

  5. Percentage of Subjects Who Achieve CDAI Response at Week 4

    Time frame: Baseline, 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.

  6. Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2

    Time frame: Baseline, 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.

  7. Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4

    Time frame: Baseline, 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.

  8. Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6

    Time frame: Baseline, 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.

  9. Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2

    Time frame: Week 2

    Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.

  10. Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4

    Time frame: Week 4

    Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.

  11. Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6

    Time frame: Week 6

    Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.

  12. Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2

    Time frame: Baseline, 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).

  13. Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4

    Time frame: Baseline, 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).

  14. Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6

    Time frame: Baseline, 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).

  15. Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2

    Time frame: 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.

  16. Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4

    Time frame: 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.

  17. Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6

    Time frame: 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.

  18. Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2

    Time frame: 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 )

  19. Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4

    Time frame: 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 )

  20. Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6

    Time frame: 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 )

  21. Concentration of C-reactive Protein (CRP) Value at Week 2

    Time frame: Week 2

    CRP data for subjects receiving rescue medication were excluded.

  22. Concentration of C-reactive Protein (CRP) Value at Week 4

    Time frame: Week 4

    CRP data for subjects receiving rescue medication were excluded.

  23. Concentration of C-reactive Protein (CRP) Value at Week 6

    Time frame: Week 6

    CRP data for subjects receiving rescue medication were excluded.

  24. C-reactive Protein (CRP) Ratio to Baseline at Week 2

    Time frame: Baseline, Week 2

    CRP data for subjects receiving rescue medication were excluded.

  25. C-reactive Protein (CRP) Ratio to Baseline at Week 4

    Time frame: Baseline, Week 4

    CRP data for subjects receiving rescue medication were excluded.

  26. C-reactive Protein (CRP) Ratio to Baseline at Week 6

    Time frame: Baseline, Week 6

    CRP data for subjects receiving rescue medication were excluded.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 14, 2006
Registry last updated
Aug 3, 2020

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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