PROSPECTIVE STUDY ?IBDISC?: Regeneration and Immunity in patients affected by IBD undergoing immunomodulatory treatment and adjuvant role of G-CSF and/or plasmapheresis (Inflammatory Bowel Diseases Immunity and Stem Cells) - IBDISC

• Conditions: Inflammatory bowel disease; MedDRA version: 9.1Level: PTClassification code 10011401; MedDRA version: 9.1Level: LLTClassification code 10045282

• Registration Number: EUCTR2008-008285-12-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

This will be a monocentric, prospective trial, open label. 24 consecutive patients affected by crohn disease (CD) and 24 patients affected by ulcerative colitis (UC) will be enrolled. - moderate-severe disease activity from a clinical and endscopic point of view (Mayo score >6) - estensive lesions (L2-L3 sec. Montreal) - candidate to receive a biological treatment with anti-TNFα (Infliximab - IFX - or Adalimumab ?ADA-), because of resistance, dependence or intolerance to conventional treatments, or because of the presence of fistulae (CD) resistant to common therapies. At the moment of the enrollment, patients will be required to sign a written 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

- Tuberculosis or other severe infections (sepsis, etc) - moderate ? severe heart failure (Class III/IV NYHA) and/or hemodynamic instability - known ipersensitivity to the drugs (Infliximab; Adalimumab; G-CSF), to murine proteins or the any of the eccipients contained in the drugs - Kostman Syndrome (severe congenital neutropenia), myelodysplastic syndromes, chronic myeloid leucemia - Anemia and/or coagulopathies and/or anticoagulant treatments

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: - feasibility and tollerability.;Secondary Objective: nd;Primary end point(s): nd