Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease

Phase 2TerminatedNCT00304252

EMD Serono192 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

192

Conditions

Crohn's Disease

Interventions

Interferon beta-1aDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Medical Information Office

Munich, Germany

Medical Information Office

Roma, Italy

Medical Information Office

Solna, Sweden

Medical Information Office

Zug, Switzerland

Medical Information Office

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.