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
2 other identifiers
interventional
94
1 country
22
Brief Summary
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2006
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
February 14, 2006
CompletedStudy Start
First participant enrolled
March 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2007
CompletedResults Posted
Study results publicly available
August 3, 2020
CompletedAugust 3, 2020
July 1, 2020
1.7 years
February 10, 2006
February 8, 2018
July 14, 2020
Conditions
Keywords
Outcome Measures
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.
Baseline, Week 6
Secondary Outcomes (26)
Crohn's Disease Activity Index (CDAI) Score at Week 2
Week 2
Crohn's Disease Activity Index (CDAI) Score at Week 4
Week 4
Crohn's Disease Activity Index (CDAI) Score at Week 6
Week 6
Percentage of Subjects Who Achieve CDAI Response at Week 2
Baseline, Week 2
Percentage of Subjects Who Achieve CDAI Response at Week 4
Baseline, Week 4
- +21 more secondary outcomes
Study Arms (3)
Certolizumab pegol 200 mg
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Placebo
PLACEBO COMPARATORSubjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
Interventions
* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use
* Active Substance: isotonic sodium chloride solution * Pharmaceutical Form: Solution for injection * Concentration: 1 mL * Route of Administration: Subcutaneous use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (22)
Unknown Facility
Aichi-Gun, Aichi-ken, Japan
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Toyoake, Aichi-ken, Japan
Unknown Facility
Toyohashi, Aichi-ken, Japan
Unknown Facility
Kashiwa, Chiba, Japan
Unknown Facility
Sakura, Chiba, Japan
Unknown Facility
Chikusino, Fukuoka, Japan
Unknown Facility
Asahikawa, Hokkaido, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Nishinomiya, Hyōgo, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Miyazaki-gun, Miyazaki, Japan
Unknown Facility
Kurashiki, Okayama-ken, Japan
Unknown Facility
Tyuto-gun, Okinawa, Japan
Unknown Facility
Suita, Osaka, Japan
Unknown Facility
Ōtsu, Shiga, Japan
Unknown Facility
Shinjyuku, Tokyo, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Kagoshima, Japan
Unknown Facility
Nagasaki, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Osaka, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2006
First Posted
February 14, 2006
Study Start
March 2, 2006
Primary Completion
November 8, 2007
Study Completion
November 8, 2007
Last Updated
August 3, 2020
Results First Posted
August 3, 2020
Record last verified: 2020-07