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

Crohn's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291668
• Other study ID #: C87037
• Secondary ID: 2014-004399-42
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2006
• Est. completion date: November 8, 2007

Study information

• Verified date: July 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 8, 2007
• Est. primary completion date: November 8, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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:

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concentration of C-reactive Protein (CRP) Value at Week 2	CRP data for subjects receiving rescue medication were excluded.	Week 2
Secondary	Concentration of C-reactive Protein (CRP) Value at Week 4	CRP data for subjects receiving rescue medication were excluded.	Week 4
Secondary	Concentration of C-reactive Protein (CRP) Value at Week 6	CRP data for subjects receiving rescue medication were excluded.	Week 6
Secondary	C-reactive Protein (CRP) Ratio to Baseline at Week 2	CRP data for subjects receiving rescue medication were excluded.	Baseline, Week 2
Secondary	C-reactive Protein (CRP) Ratio to Baseline at Week 4	CRP data for subjects receiving rescue medication were excluded.	Baseline, Week 4
Secondary	C-reactive Protein (CRP) Ratio to Baseline at Week 6	CRP data for subjects receiving rescue medication were excluded.	Baseline, Week 6

External Links

•   Clinical Study Summary on UCB.com
•   FDA Safety Alerts and Recalls
•   Product Information