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

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

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

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Certolizumab Pegol; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; Other: Placebo; Active Substance: isotonic sodium chloride solution; Pharmaceutical Form: Solution for injection; Concentration: 1 mL; Route of Administration: Subcutaneous use
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; 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_COMPARATOR: Placebo; Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.	Other: Placebo; Active Substance: isotonic sodium chloride solution; Pharmaceutical Form: Solution for injection; Concentration: 1 mL; Route of Administration: Subcutaneous use

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2006
• Primary Completion (ACTUAL): November 8, 2007
• Study Completion (ACTUAL): November 8, 2007

Study Registration Dates

• First Submitted: February 10, 2006
• First Submitted That Met QC Criteria: February 10, 2006
• First Posted (ESTIMATE): February 14, 2006

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Crohn's Disease; CDP870; Certolizumab pegol
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Certolizumab Pegol
• Other Study ID Numbers: C87037; 2014-004399-42 (EUDRACT_NUMBER)