A multicentre, prospective, randomised phase III study conducted by the European Crohn's and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT)
- Conditions
- Crohn's Disease
- Registration Number
- EUCTR2005-003337-40-BE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- age between 18 and 50 years
- confirmed diagnosis of active Crohn's Disease
- unsatisfactory course despite 3 immunosuppressive agents in addition to corticosteroids
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- BMI < 18
- concomitant severe disease
- infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the potential clinical benefit of hematopoeitic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice in patients with Crohn's Disease.;Secondary Objective: - To evaluate the safety of Hematopoietic Stem Cell Transplantation (HSCT) in Crohn's disease patients who have not responded to immunosuppressant medication<br>- To evaluate the impact of HSCT on health related, and generic, quality of life measures<br>- To identify factors predictive of success;Primary end point(s): the proportion of patients in sustained disease remission at one year.
- Secondary Outcome Measures
Name Time Method