Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn’s Disease - Full Text View

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00304252

Purpose

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.

Condition	Intervention	Phase
Crohn’s Disease	Drug: Interferon beta-1a	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Interferons Interferon beta Interferon-beta Interferon beta 1a

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by EMD Serono:

Primary Outcome Measures:

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:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304252

Locations

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Claudia Pena Rossi, M.D.

EMD Serono

More Information

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

Study ID Numbers:	22916, 9903
Study First Received:	March 14, 2006
Last Updated:	July 9, 2007
ClinicalTrials.gov Identifier:	NCT00304252
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Interferon Type I, Recombinant
Digestive System Diseases
Gastrointestinal Diseases
Interferons
Crohn Disease

Interferon beta 1a
Interferon-beta
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Adjuvants, Immunologic
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009