NCT00304252TerminatedPhase 2
A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- EMD Serono
- Enrollment
- 192
- Locations
- 5
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- 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.
Investigators
Study Sites (5)
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