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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2006-002027-16-GR
Date of registration: 05/09/2006
Prospective Registration: Yes
Primary sponsor: UCB AE
Public title: Certolizumab pegol 400 mg monthly 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 the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.
Scientific title: Certolizumab pegol 400 mg monthly 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 the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action.
Date of first enrolment: 12/12/2006
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002027-16
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Greece
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Adult men and women = 18 years·
Patient suffering from Crohn’s disease with a CDAI score between 220 and 450, scored over the 7 days prior to the first study treatment dose·
Patients must have been treated and must have responded to infliximab (estimated by the Investigator and documented by the patient’s medical file) but are no longer responding or have developed intolerability due to acute or delayed infusion reactions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Crohn’s Disease Related·
Symptomatic obstructive intestinal strictures·
Functional colostomy or ileostomy (patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).·
Bowel resection within 4 weeks of starting the study medication·
Current total parenteral nutrition·
Short bowel syndrome·
Positive stool laboratory results for enteric pathogens·
Antibiotic treatment for non- Crohn’s related infections within 3 weeks prior to screening
Medical History Exclusion·
Ulcerative colitis·
Lactating and / or pregnant female patients.·
Female patients of childbearing age who are NOT practicing (in the Investigator’s opinion) effective birth control.
All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every CDP870 administration.·
A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough).·
A history of tuberculosis or positive chest X-ray for tuberculosis or positive (defined as positive induration per local medical practice) PPD skin test.
Patients with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB may be enrolled at the discretion of the Investigator. Consideration should be given to the fact that a positive PPD skin test with prior vaccination does not exclude latent TB·
A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.·
Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
Patients with known concurrent viral hepatitis or known positivity to HBe-Ag, HBV DNA, HBV DNA polymerase, HCVRNA, anti HCV antibodies with decompensated liver function will not be enrolled in the study·
Receipt of any vaccination (live or attenuated) within 8 weeks prior to Baseline. (Influenza and Pneumococcal vaccines are allowed).
Known human immunodeficiency virus (HIV) infection.
New York Heart Association (NYHA) class III-IV congestive heart failure requiring medical treatment.
A history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
Previous clinical trials and previous biological therapy exclusion ·
Patients treated with infliximab within 12 weeks prior to screening


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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 the response or have developed intolerance to infliximab
Intervention(s)

Product Name: certolizumab pegol
Product Code: CDP870
Pharmaceutical Form: Powder for solution for injection

Primary Outcome(s)
Main Objective: To assess the clinical efficacy of subcutaneous certolizumab pegol 400 mg at week 6, following administration at 0, 2 and 4 weeks for the treatment of signs and symptoms of active Crohn’s Disease (CDAI between 220 and 450 inclusive: scored over 7 days before the first administration of the study drug) in patients who have previously received and responded to infliximab, but who no longer have a sustained response and / or tolerance to infliximab.
Primary end point(s): Response rate at week 6 with response defined as at least 100 point decrease of CDAI score from baseline
Secondary Objective: Assess the clinical efficacy of sc certolizumab pegol 400 mg at week 14, administered Q4W, in patients with Crohn’s disease who have previously received and responded to infliximab, but who no longer have a sustained response and / or tolerance to infliximab.Assess the onset of action of certolizumab pegol at week 1, following initial administration at week 0 as measured by: 1.CDAI score response and change from baseline, 2.CRP levels.Assess the clinical remissionof sc certolizumab pegol 400 mg over the treatment period,administered Q4W, in patients with Crohn’s disease who have previously received and responded to infliximab, but who no longer have a sustained response and / or tolerance to infliximab.To evaluate tolerability and safety of certolizumab pegol therapy (week 14) in patients who have previously received and responded to infliximab, but who no longer have a sustained response and / or tolerance to infliximab.Patients’ health related quality of life as assessed by the IBDQ.
Secondary Outcome(s)
Secondary ID(s)
RPCG06B2433
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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