Estudio prospectivo para la evaluación de la seguridad y eficacia a largo plazo de Cx401 en pacientes que hayan participado en el ensayo clínico FATT2.A prospective study for the assessment of the long-term safety and efficacy of Cx401 in patients taking part in the FATT2 trial.

• Conditions: Fistula perianal compleja en la enfermedad perianal de CrohnComplex perianal fistula in perianal Crohn´s disease; MedDRA version: 9Level: LLTClassification code 10002156Term: Anal fistula

• Registration Number: EUCTR2009-014775-42-ES
• Lead Sponsor: CELLERIX S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

To be eligible for this study, patients should meet ALL the following criteria:
1. Received at least one dose of the treatment assigned in the FATT2 trial.
2. Patient should give his/her written informed consent.
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

To be eligible for this study, patients should meet NONE of the following criteria:
1. Receive clinical investigational drugs other than Cx401 during the follow-up
period.
2. Treatment with Infliximab or any other anti-TNF treatment throughout the study
(only applicable to patients allocated to the placebo group during the FATT2
core study)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the long-term safety of Cx401 in patients with complex perianal fistulas in<br>Crohn?s disease.;Secondary Objective: To assess the state of closure of the fistula (MRI) at 24 weeks of follow-up in all<br>patients of the extension study, and at 12 weeks of follow-up in those patients who<br>received placebo in the FATT2 core study.;Primary end point(s): All clinical and laboratory adverse events will be recorded during the follow-up<br>contacts: at baseline and 24 weeks of the extension period in patients treated with<br>Cx401 in the FATT2 core study; and at baseline, implant, 1, 12, 13 and 24 weeks in<br>patients treated with placebo in the FATT2 core study.<br>The primary variable will be the cumulative incidence of adverse events attributed to<br>the study therapy (Cx401).