CClinicalTrials.gg
Sign In
CompletedNCT00291668Updated Aug 3, 2020Results posted

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

A Phase 2 interventional study of Certolizumab Pegol and Placebo in Crohn's Disease, sponsored by UCB Pharma. Completed at 22 sites in Japan. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-08-03.

Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Crohn's Disease

Browse trials for

Keywords

  • Crohn's Disease
  • CDP870
  • Certolizumab pegol
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 94 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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:

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    Certolizumab pegol 200 mg

    Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.

    Biological: Certolizumab Pegol · Other: Placebo

  • Experimental
    Certolizumab pegol 400 mg

    Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

    Biological: Certolizumab Pegol

  • Placebo comparator
    Placebo

    Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

    Other: Placebo

Interventions

  • BiologicalCertolizumab Pegol

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

    Also known as: CDP870

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Week 6

Secondary outcomes

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

    Time frame: Week 2

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

    Time frame: Week 4

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

    Time frame: Week 6

  4. Percentage of Subjects Who Achieve CDAI Response at 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.

    Time frame: Baseline, Week 2

  5. Percentage of Subjects Who Achieve CDAI Response at 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.

    Time frame: Baseline, Week 4

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

    Time frame: Baseline, Week 2

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

    Time frame: Baseline, Week 4

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

    Time frame: Baseline, Week 6

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

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

    Time frame: Week 2

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

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

    Time frame: Week 4

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

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

    Time frame: Week 6

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

    Time frame: Baseline, Week 2

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

    Time frame: Baseline, Week 4

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

    Time frame: Baseline, Week 6

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

    Time frame: Week 2

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

    Time frame: Week 4

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

    Time frame: Week 6

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

    Time frame: Week 2

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

    Time frame: Week 4

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

    Time frame: Week 6

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

    CRP data for subjects receiving rescue medication were excluded.

    Time frame: Week 2

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

    CRP data for subjects receiving rescue medication were excluded.

    Time frame: Week 4

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

    CRP data for subjects receiving rescue medication were excluded.

    Time frame: Week 6

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

    CRP data for subjects receiving rescue medication were excluded.

    Time frame: Baseline, Week 2

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

    CRP data for subjects receiving rescue medication were excluded.

    Time frame: Baseline, Week 4

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

    CRP data for subjects receiving rescue medication were excluded.

    Time frame: Baseline, Week 6

07

Results

Posted Aug 3, 2020

Participant flow

This study started to enroll subjects in March 2006 and conluded in November 2007.

Participant flow — Overall Study
MilestonePlaceboCertolizumab Pegol 200 mgCertolizumab Pegol 400 mg
Started323032
Completed282931
Not completed411
Withdrew: Lack of efficacy100
Withdrew: Sae, non-fatal111
Withdrew: Ae, non-serious non-fatal100
Withdrew: Sae, non-fatal+ae, non-serious non-fatal100

Outcome measures

PrimaryCrohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at 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.

Time frame:
Baseline, Week 6
Reported as:
Number · percentage of subjects
Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 625.0 (10.0 to 40.0)43.3 (25.6 to 61.1)48.4 (30.8 to 66.0)
SecondaryCrohn's Disease Activity Index (CDAI) Score at 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.

Time frame:
Week 2
Reported as:
Mean · units on a scale
Crohn's Disease Activity Index (CDAI) Score at Week 2
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Crohn's Disease Activity Index (CDAI) Score at Week 2255.9 ± 68.02214.2 ± 83.51224.9 ± 85.05
SecondaryCrohn's Disease Activity Index (CDAI) Score at 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.

Time frame:
Week 4
Reported as:
Mean · units on a scale
Crohn's Disease Activity Index (CDAI) Score at Week 4
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Crohn's Disease Activity Index (CDAI) Score at Week 4243.1 ± 68.57199.7 ± 91.25204.6 ± 75.10
SecondaryCrohn's Disease Activity Index (CDAI) Score at 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.

Time frame:
Week 6
Reported as:
Mean · units on a scale
Crohn's Disease Activity Index (CDAI) Score at Week 6
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Crohn's Disease Activity Index (CDAI) Score at Week 6232.4 ± 89.28211.0 ± 99.91198.1 ± 87.88
SecondaryPercentage of Subjects Who Achieve CDAI Response at 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.

Time frame:
Baseline, Week 2
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve CDAI Response at Week 2
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve CDAI Response at Week 215.6 (3.0 to 28.2)40.0 (22.5 to 57.5)32.3 (15.8 to 48.7)
SecondaryPercentage of Subjects Who Achieve CDAI Response at 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.

Time frame:
Baseline, Week 4
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve CDAI Response at Week 4
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve CDAI Response at Week 421.9 (7.6 to 36.2)46.7 (28.8 to 64.5)38.7 (21.6 to 55.9)
SecondaryPercentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at 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.

Time frame:
Baseline, Week 2
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 228.1 (12.5 to 43.7)46.7 (28.8 to 64.5)45.2 (27.6 to 62.7)
SecondaryPercentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at 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.

Time frame:
Baseline, Week 4
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 425.0 (10.0 to 40.0)56.7 (38.9 to 74.4)54.8 (37.3 to 72.4)
SecondaryPercentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at 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.

Time frame:
Baseline, Week 6
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 643.8 (26.6 to 60.9)53.3 (35.5 to 71.2)61.3 (44.1 to 78.4)
SecondaryPercentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2

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

Time frame:
Week 2
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 23.1 (0.0 to 9.2)20.0 (5.7 to 34.3)16.1 (3.2 to 29.1)
SecondaryPercentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4

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

Time frame:
Week 4
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 46.3 (0.0 to 14.6)26.7 (10.8 to 42.5)22.6 (7.9 to 37.3)
SecondaryPercentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6

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

Time frame:
Week 6
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 615.6 (3.0 to 28.2)26.7 (10.8 to 42.5)32.3 (15.8 to 48.7)
SecondaryPercentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) 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).

Time frame:
Baseline, Week 2
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 215.6 (3.0 to 28.2)36.7 (19.4 to 53.9)29.0 (13.1 to 45.0)
SecondaryPercentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) 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).

Time frame:
Baseline, Week 4
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 418.8 (5.2 to 32.3)36.7 (19.4 to 53.9)32.3 (15.8 to 48.7)
SecondaryPercentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) 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).

Time frame:
Baseline, Week 6
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
percentage of subjectsFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 621.9 (7.6 to 36.2)36.7 (19.4 to 53.9)41.9 (24.6 to 59.3)
SecondaryInflammatory Bowel Disease Questionnaire (IBDQ) Global Score at 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.

Time frame:
Week 2
Reported as:
Mean · units on a scale
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2171.3 ± 22.45166.1 ± 22.14169.7 ± 23.24
SecondaryInflammatory Bowel Disease Questionnaire (IBDQ) Global Score at 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.

Time frame:
Week 4
Reported as:
Mean · units on a scale
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4172.6 ± 24.04169.4 ± 21.75170.3 ± 23.72
SecondaryInflammatory Bowel Disease Questionnaire (IBDQ) Global Score at 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.

Time frame:
Week 6
Reported as:
Mean · units on a scale
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6173.1 ± 25.49165.6 ± 23.25170.8 ± 24.54
SecondaryInflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at 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 )

Time frame:
Week 2
Reported as:
Mean · units on a scale
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Bowel Symptoms Domain Score54.4 ± 7.1753.4 ± 8.1854.7 ± 8.77
Systemic Symptoms Domain Score22.4 ± 5.0122.4 ± 5.1722.7 ± 4.51
Emotional Function Domain Score65.3 ± 8.9162.3 ± 9.5463.3 ± 8.53
Social Function Domain Score29.4 ± 5.6428.0 ± 4.3329.0 ± 5.03
SecondaryInflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at 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 )

Time frame:
Week 4
Reported as:
Mean · units on a scale
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Bowel Symptoms Domain Score55.4 ± 7.2254.0 ± 9.0055.5 ± 8.04
Systemic Symptoms Domain Score23.3 ± 5.4923.4 ± 4.2122.9 ± 4.44
Emotional Function Domain Score65.3 ± 8.8563.1 ± 8.9063.2 ± 9.55
Social Function Domain Score28.8 ± 6.7328.9 ± 4.8228.7 ± 5.62
SecondaryInflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at 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 )

Time frame:
Week 6
Reported as:
Mean · units on a scale
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
units on a scaleFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Bowel Symptoms Domain Score55.4 ± 7.7751.8 ± 8.4455.8 ± 8.43
Systemic Symptoms Domain Score23.3 ± 6.7422.4 ± 4.4923.4 ± 4.62
Emotional Function Domain Score65.3 ± 8.7663.2 ± 9.4562.1 ± 10.43
Social Function Domain Score29.2 ± 6.4828.1 ± 5.6929.5 ± 5.09
SecondaryConcentration of C-reactive Protein (CRP) Value at Week 2

CRP data for subjects receiving rescue medication were excluded.

Time frame:
Week 2
Reported as:
Geometric mean · mg/L
Concentration of C-reactive Protein (CRP) Value at Week 2
mg/LFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Concentration of C-reactive Protein (CRP) Value at Week 222.15 (15.43 to 31.80)13.58 (9.45 to 19.52)13.86 (9.11 to 21.09)
SecondaryConcentration of C-reactive Protein (CRP) Value at Week 4

CRP data for subjects receiving rescue medication were excluded.

Time frame:
Week 4
Reported as:
Geometric mean · mg/L
Concentration of C-reactive Protein (CRP) Value at Week 4
mg/LFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Concentration of C-reactive Protein (CRP) Value at Week 423.47 (16.02 to 34.40)12.87 (8.56 to 19.36)12.02 (8.68 to 16.65)
SecondaryConcentration of C-reactive Protein (CRP) Value at Week 6

CRP data for subjects receiving rescue medication were excluded.

Time frame:
Week 6
Reported as:
Geometric mean · mg/L
Concentration of C-reactive Protein (CRP) Value at Week 6
mg/LFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
Concentration of C-reactive Protein (CRP) Value at Week 623.32 (16.95 to 32.07)15.10 (9.46 to 24.11)12.62 (8.79 to 18.11)
SecondaryC-reactive Protein (CRP) Ratio to Baseline at Week 2

CRP data for subjects receiving rescue medication were excluded.

Time frame:
Baseline, Week 2
Reported as:
Geometric mean · ratio
C-reactive Protein (CRP) Ratio to Baseline at Week 2
ratioFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
C-reactive Protein (CRP) Ratio to Baseline at Week 20.85 (0.64 to 1.13)0.58 (0.42 to 0.80)0.50 (0.35 to 0.72)
SecondaryC-reactive Protein (CRP) Ratio to Baseline at Week 4

CRP data for subjects receiving rescue medication were excluded.

Time frame:
Baseline, Week 4
Reported as:
Geometric mean · ratio
C-reactive Protein (CRP) Ratio to Baseline at Week 4
ratioFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
C-reactive Protein (CRP) Ratio to Baseline at Week 41.04 (0.83 to 1.31)0.53 (0.37 to 0.76)0.44 (0.32 to 0.60)
SecondaryC-reactive Protein (CRP) Ratio to Baseline at Week 6

CRP data for subjects receiving rescue medication were excluded.

Time frame:
Baseline, Week 6
Reported as:
Geometric mean · ratio
C-reactive Protein (CRP) Ratio to Baseline at Week 6
ratioFull Analysis Set (Placebo Treated Subjects)Full Analysis Set (CZP 200 mg Treated Subjects)Full Analysis Set (CZP 400 mg Treated Subjects)
C-reactive Protein (CRP) Ratio to Baseline at Week 61.03 (0.85 to 1.25)0.63 (0.40 to 0.98)0.46 (0.32 to 0.66)

Adverse events

Collected over Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/32 (0%)3/32 (9.4%)16/32 (50%)
Certolizumab Pegol 200 mg0/30 (0%)1/30 (3.3%)11/30 (36.7%)
Certolizumab Pegol 400 mg0/32 (0%)3/32 (9.4%)14/32 (43.8%)
Most frequent serious events
Most frequent serious events
EventPlaceboCertolizumab Pegol 200 mgCertolizumab Pegol 400 mg
Crohn's diseaseGastrointestinal disorders3/320/300/32
PyrexiaGeneral disorders0/320/302/32
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders0/321/300/32
Disseminated intravascular coagulationBlood and lymphatic system disorders0/320/301/32
Abdominal painGastrointestinal disorders0/320/301/32
Gastrointestinal haemorrhageGastrointestinal disorders1/320/300/32
PeritonitisGastrointestinal disorders1/320/300/32
SepsisInfections and infestations0/320/301/32
Most frequent other events
Showing 10 of 11
Most frequent other events
EventPlaceboCertolizumab Pegol 200 mgCertolizumab Pegol 400 mg
NasopharyngitisInfections and infestations10/327/307/32
NauseaGastrointestinal disorders1/322/302/32
VomitingGastrointestinal disorders0/322/301/32
PyrexiaGeneral disorders2/322/301/32
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders0/322/301/32
Hepatic function abnormalHepatobiliary disorders2/320/300/32
White blood cell count decreasedInvestigations0/320/302/32
HeadacheNervous system disorders2/320/301/32
Pharynx discomfortRespiratory, thoracic and mediastinal disorders0/321/302/32
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders1/320/302/32

Baseline characteristics

Baseline Characteristics refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).

Age, Categorical
Age, Categorical(Participants)PlaceboCertolizumab Pegol 200 mgCertolizumab Pegol 400 mgTotal Title
<=18 years2226
Between 18 and 65 years30283088
>=65 years0000
Age, Continuous
Age, Continuous(years)PlaceboCertolizumab Pegol 200 mgCertolizumab Pegol 400 mgTotal Title
Mean30.6 ± 8.1632.7 ± 9.3431.4 ± 8.2731.5 ± 8.54
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboCertolizumab Pegol 200 mgCertolizumab Pegol 400 mgTotal Title
Female68721
Male26222573
08

Study locations

22 sites
  • Aichi-Gun, Aichi, Japan
  • Nagoya, Aichi, Japan
  • Toyoake, Aichi, Japan
  • Toyohashi, Aichi, Japan
  • Kashiwa, Chiba, Japan
  • Sakura, Chiba, Japan
  • Chikusino, Fukuoka, Japan
  • Asahikawa, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Nishinomiya, Hyogo, Japan
  • Yokohama, Kanagawa, Japan
  • Miyazaki-gun, Miyazaki, Japan
  • Kurashiki, Okayama, Japan
  • Tyuto-gun, Okinawa, Japan
  • Suita, Osaka, Japan
  • Otsu, Shiga, Japan
  • Shinjyuku, Tokyo, Japan
  • Fukuoka, Japan
  • Kagoshima, Japan
  • Nagasaki, Japan
  • Niigata, Japan
  • Osaka, Japan
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00291668
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Feb 14, 2006
Start date
Mar 2, 2006
Primary completion
Nov 8, 2007
Completion
Nov 8, 2007
Results posted
Aug 3, 2020
Last update
Aug 3, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Crohn Disease→

Other studies from this sponsor

UCB Pharma

Start the discussion