Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease
Phase 2
Terminated
- Conditions
- Crohn's Disease
- Registration Number
- NCT00304252
- Lead Sponsor
- EMD Serono
- Brief Summary
The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 192
Inclusion Criteria
- Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study
Exclusion Criteria
- Any other treatment for the maintenance of remission of Crohn's disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26.
- Secondary Outcome Measures
Name Time Method The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures: The proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 52 Time to relapse Change from baseline to end of treatment in Quality of Life (IBDQ) score, CDAI score, biological markers of inflammation (CRP and ESR), number of fistulas (including new fistulas and closure of existing ones), and antibodies to interferon beta-1a.
Trial Locations
- Locations (1)
Medical Information Office
🇬🇧Feltham, United Kingdom