Clinical trial NCT00291668: Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
CDP870
Certolizumab pegol
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 94
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

Primary outcomes:
measure: Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Crohn's Disease Activity Index (CDAI) Score at Week 2
timeFrame: Week 2
measure: Crohn's Disease Activity Index (CDAI) Score at Week 4
timeFrame: Week 4
measure: Crohn's Disease Activity Index (CDAI) Score at Week 6
timeFrame: Week 6
measure: Percentage of Subjects Who Achieve CDAI Response at Week 2
timeFrame: Baseline, Week 2
measure: Percentage of Subjects Who Achieve CDAI Response at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
timeFrame: Baseline, Week 2
measure: Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
timeFrame: Baseline, Week 6
measure: Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
timeFrame: Week 2
measure: Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
timeFrame: Week 4
measure: Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
timeFrame: Week 6
measure: Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
timeFrame: Baseline, Week 2
measure: Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
timeFrame: Baseline, Week 6
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
timeFrame: Week 2
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
timeFrame: Week 4
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
timeFrame: Week 6
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
timeFrame: Week 2
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
timeFrame: Week 4
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
timeFrame: Week 6
measure: Concentration of C-reactive Protein (CRP) Value at Week 2
timeFrame: Week 2
measure: Concentration of C-reactive Protein (CRP) Value at Week 4
timeFrame: Week 4
measure: Concentration of C-reactive Protein (CRP) Value at Week 6
timeFrame: Week 6
measure: C-reactive Protein (CRP) Ratio to Baseline at Week 2
timeFrame: Baseline, Week 2
measure: C-reactive Protein (CRP) Ratio to Baseline at Week 4
timeFrame: Baseline, Week 4
measure: C-reactive Protein (CRP) Ratio to Baseline at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Aichi-Gun
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Toyoake
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Sakura
country: Japan
state: Chiba
city: Chikusino
country: Japan
state: Fukuoka
city: Asahikawa
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Nishinomiya
country: Japan
state: Hyogo
city: Yokohama
country: Japan
state: Kanagawa
city: Miyazaki-gun
country: Japan
state: Miyazaki
city: Kurashiki
country: Japan
state: Okayama
city: Tyuto-gun
country: Japan
state: Okinawa
city: Suita
country: Japan
state: Osaka
city: Otsu
country: Japan
state: Shiga
city: Shinjyuku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Osaka
country: Japan
Study officials:
References: