Crohn's Disease
Conditions
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.
Interventions
DRUGInterferon beta-1a
Sponsors
EMD Serono
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany, Italy, Sweden, Switzerland, United Kingdom
Outcome results
None listed