Know Cancer

or
forgot password

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.


Phase 3
18 Years
N/A
Not Enrolling
Both
Crohn's Disease

Thank you

Trial Information

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.


Inclusion Criteria:



- Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI)
≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with
Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8

- Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

Exclusion Criteria:

- Obstructive intestinal strictures, bowel resection, proctocolectomy or total
colectomy, current total parenteral nutrition, short bowel syndrome

- History of tuberculosis or positive tests for tuberculosis at screening

- All the concomitant diseases or pathological conditions that could interfere with
Crohn's disease assessment or to be harmful for the well being of the patient

- Previous clinical trials and previous biological therapy that could interfere with
the results in the present clinical trial

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments

Outcome Description:

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

Outcome Time Frame:

Baseline, Week 10

Safety Issue:

No

Principal Investigator

UCB Clinical Trial Call Center

Investigator Role:

Study Director

Investigator Affiliation:

+1 877 822 9493 (UCB)

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

C87043

NCT ID:

NCT00297648

Start Date:

February 2006

Completion Date:

December 2009

Related Keywords:

  • Crohn's Disease
  • Certolizumab pegol
  • Crohn's disease
  • Mucosal healing
  • Crohn Disease

Name

Location