Clinical trial NCT00307931: Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
Official title: Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Certolizumab pegol
Cimzia
Crohn's disease
Greek patients
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-03-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab


Eligibility criteria: Inclusion Criteria:

• Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

Exclusion Criteria:

* Symptomatic obstructive intestinal strictures
* Bowel resection within 4 weeks
* Current total parenteral nutrition
* Short bowel syndrome
* Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.

Primary outcomes:
measure: Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal
timeFrame: Baseline to Weeks 1, and 14 or Withdrawal
measure: Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14
timeFrame: Baseline to Weeks 1, 6 and 14
measure: Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal
timeFrame: Weeks 1, 6 and 14 or Withdrawal
measure: Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
timeFrame: Weeks 1, 2, 4, 6, 8, 12 and 14
measure: Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
timeFrame: Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14
measure: C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
timeFrame: Weeks 1, 2, 4, 6, 8, 12 and 14
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14
timeFrame: Baseline, and Weeks 6 and 14
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14
timeFrame: Baseline, and Weeks 6 and 14
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14
timeFrame: Baseline, and Weeks 6 and 14
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14
timeFrame: Baseline, and Weeks 6 and 14
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14
timeFrame: Baseline, and Weeks 6 and 14
Other outcomes:
Locations:
city: Heraclion
country: Greece
state: Crete
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Piraeus
country: Greece
city: Thessaloniki
country: Greece
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: