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

Phase 2

Completed

Conditions: Crohn's Disease

Interventions: Biological: Certolizumab Pegol
Other: Placebo

Registration Number: NCT00291668

Lead Sponsor: UCB Pharma

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 94

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:

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Certolizumab pegol 200 mg	Placebo	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.
Placebo	Placebo	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
Certolizumab pegol 200 mg	Certolizumab Pegol	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.
Certolizumab pegol 400 mg	Certolizumab Pegol	Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6	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 Outcome Measures

Name	Time	Method
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2	Week 2	Remission at Week 2 is defined as a CDAI score \<= 150 points at Week 2.
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2	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).
Concentration of C-reactive Protein (CRP) Value at Week 2	Week 2	CRP data for subjects receiving rescue medication were excluded.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6	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.
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2	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.
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2	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 )
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6	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 )
Crohn's Disease Activity Index (CDAI) Score at Week 2	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.
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4	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.
C-reactive Protein (CRP) Ratio to Baseline at Week 4	Baseline, Week 4	CRP data for subjects receiving rescue medication were excluded.
Concentration of C-reactive Protein (CRP) Value at Week 4	Week 4	CRP data for subjects receiving rescue medication were excluded.
Crohn's Disease Activity Index (CDAI) Score at Week 4	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.
Crohn's Disease Activity Index (CDAI) Score at Week 6	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.
Percentage of Subjects Who Achieve CDAI Response at Week 2	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.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2	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.
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4	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.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4	Week 4	Remission at Week 4 is defined as a CDAI score \<= 150 points at Week 4.
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4	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).
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6	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).
Concentration of C-reactive Protein (CRP) Value at Week 6	Week 6	CRP data for subjects receiving rescue medication were excluded.
Percentage of Subjects Who Achieve CDAI Response at Week 4	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.
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6	Week 6	Remission at Week 6 is defined as a CDAI score \<= 150 points at Week 6.
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6	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.
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4	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 )
C-reactive Protein (CRP) Ratio to Baseline at Week 6	Baseline, Week 6	CRP data for subjects receiving rescue medication were excluded.
C-reactive Protein (CRP) Ratio to Baseline at Week 2	Baseline, Week 2	CRP data for subjects receiving rescue medication were excluded.