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

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

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: Certolizumab Pegol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certolizumab pegol 200 mg<br>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<br>* Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use<br>* Other names: CDP870;Other: Placebo<br>* Active Substance: isotonic sodium chloride solution Pharmaceutical Form: Solution for injection Concentration: 1 mL Route of Administration: Subcutaneous use<br>|
| Experimental: Certolizumab pegol 400 mg<br>Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. | Biological: Certolizumab Pegol<br>* Active Substance: Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use<br>* Other names: CDP870;|
| Placebo Comparator: Placebo<br>Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. | Other: Placebo<br>* Active Substance: isotonic sodium chloride solution Pharmaceutical Form: Solution for injection Concentration: 1 mL Route of Administration: Subcutaneous use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 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. | Week 4 | 
| 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. | Week 6 | 
| 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. | Baseline, Week 2 | 
| 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. | Baseline, Week 4 | 
| 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. | Baseline, Week 2 | 
| 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. | Baseline, Week 4 | 
| 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. | Baseline, Week 6 | 
| 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. | Week 2 | 
| 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. | Week 4 | 
| 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. | Week 6 | 
| 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). | Baseline, Week 2 | 
| 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). | Baseline, Week 4 | 
| 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). | Baseline, Week 6 | 
| 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. | Week 2 | 
| 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. | Week 4 | 
| 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. | Week 6 | 
| 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 ) | Week 2 | 
| 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 ) | Week 4 | 
| 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 ) | Week 6 | 
| Concentration of C-reactive Protein (CRP) Value at Week 2 | CRP data for subjects receiving rescue medication were excluded. | Week 2 | 
| Concentration of C-reactive Protein (CRP) Value at Week 4 | CRP data for subjects receiving rescue medication were excluded. | Week 4 | 
| Concentration of C-reactive Protein (CRP) Value at Week 6 | CRP data for subjects receiving rescue medication were excluded. | Week 6 | 
| C-reactive Protein (CRP) Ratio to Baseline at Week 2 | CRP data for subjects receiving rescue medication were excluded. | Baseline, Week 2 | 
| C-reactive Protein (CRP) Ratio to Baseline at Week 4 | CRP data for subjects receiving rescue medication were excluded. | Baseline, Week 4 | 
| C-reactive Protein (CRP) Ratio to Baseline at Week 6 | CRP data for subjects receiving rescue medication were excluded. | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, CDP870, Certolizumab pegol