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: Interferon beta Interferon-beta Interferon beta 1a Interferons

U.S. FDA Resources

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.

Estimated Enrollment:	192
Study Start Date:	November 2001
Study Completion Date:	September 2003

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:

Any other treatment for the maintenance of remission of Crohn's disease

Contacts and Locations

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

Locations

Germany
Medical Information Office
Munich, Germany
Italy
Medical Information Office
Roma, Italy
Sweden
Medical Information Office
Solna, Sweden
Switzerland
Medical Information Office
Zug, Switzerland
United Kingdom
Medical Information Office
Feltham, United Kingdom

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Claudia Pena Rossi, M.D.

EMD Serono

More Information

Additional Information:

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

No publications provided by EMD Serono

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Pena Rossi C, Hanauer SB, Tomasevic R, Hunter JO, Shafran I, Graffner H. Interferon beta-1a for the maintenance of remission in patients with Crohn's disease: results of a phase II dose-finding study. BMC Gastroenterol. 2009 Mar 20;9:22.

Study ID Numbers:	22916, 9903
Study First Received:	March 14, 2006
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00304252 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Interferon Type I, Recombinant
Crohn's Disease
Immunologic Factors
Ileitis
Gastrointestinal Diseases
Enteritis
Interferons
Adjuvants, Immunologic
Interferon-beta
Inflammatory Bowel Diseases

Intestinal Diseases
Angiogenesis Inhibitors
Antiviral Agents
Ileal Diseases
Signs and Symptoms
Digestive System Diseases
Crohn Disease
Interferon beta 1a
Gastroenteritis

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Inflammatory Bowel Diseases
Ileal Diseases
Therapeutic Uses
Interferon beta 1a
Angiogenesis Modulating Agents
Growth Inhibitors
Ileitis

Enteritis
Growth Substances
Interferons
Interferon-beta
Adjuvants, Immunologic
Intestinal Diseases
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Digestive System Diseases
Crohn Disease
Gastroenteritis

ClinicalTrials.gov processed this record on May 06, 2009