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BENEFIT Extension Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00544037
First received: October 15, 2007
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  Purpose

To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.


Condition Intervention
Multiple Sclerosis
 Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Population of Benefit Studies


Enrollment: 283
Study Start Date: September 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Standard Therapy for Multiple Sclerosis

  Eligibility

Ages Eligible for Study:   23 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This observational study may include all patients who were randomized into and treated at least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued study participation in either study 304747 or study 305207, and patients who did not transfer from study 304747 to study 305207.

Criteria

Inclusion Criteria:

  • All patients randomized and treated at least once in study 304747

Exclusion Criteria:

  • Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544037

  Show 18 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Byer Healthcare AG
ClinicalTrials.gov Identifier: NCT00544037     History of Changes
Other Study ID Numbers: 91713, 311129
Study First Received: October 15, 2007
Last Updated: March 2, 2012
Health Authority: Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Hungary: Medical Research Council Committee for Science and Research Ethics
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 16, 2013