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

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ClinicalTrials.gov Identifier: NCT00304252
Recruitment Status : Terminated (Lack of Efficacy)
First Posted : March 17, 2006
Last Update Posted : August 6, 2013
Sponsor:
Information provided by:
EMD Serono

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Interferon beta-1a Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : November 2001
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures:
  2. 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
  3. Time to relapse
  4. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00304252     History of Changes
Other Study ID Numbers: 22916
9903
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: August 6, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic