Follow-up Study of the BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185211

Purpose

This study will primarily compare the long-term effects of an early and continued treatment with Betaferon®/Betaseron® (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated after CDMS has been diagnosed (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Betaferon/Betaseron	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label, Multi-Center Phase III Extension of the Double-Blind, Placebo-Controlled BENEFIT Study (no. 304747) to Obtain Long-Term Follow-up Data of Patients With Clinically Definite MS and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon beta-1b

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Time to Clinically Definite Multiple Sclerosis [ Time Frame: 310 weeks ] [ Designated as safety issue: No ]
Time to reach a sustained Expanded Disability Status Scale (EDSS) progression [ Time Frame: 310 weeks ] [ Designated as safety issue: No ]
Functional Assessment MS (FAMS) Trial Outcome Index at month 60 [ Time Frame: 310 weeks ] [ Designated as safety issue: No ]
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study. [ Time Frame: 310 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relapse domain (MS according to McDonald, recurrent relapses) [ Time Frame: 310 weeks ] [ Designated as safety issue: No ]
Disability domain (MSFC at month 60, conversion to SPMS, recurrent MS-related hospitalizations) Patient reported outcomes domain (EQ-5D, EQ-VAS and FAMS at 60 months) [ Time Frame: 310 weeks ] [ Designated as safety issue: No ]
MRI domain (lesion numbers and brain volume at 60 months) [ Time Frame: 310 weeks ] [ Designated as safety issue: No ]

Enrollment:	416
Study Start Date:	August 2002
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Betaferon/Betaseron 250ug administrated s.c.every other day

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS or by completing 24 months

Exclusion Criteria:

- No participation in the initial BENEFIT study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185211

Show 94 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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided by Bayer

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

Nielsen JM, Pohl C, Polman CH, Barkhof F, Freedman MS, Edan G, Miller DH, Bauer L, Sandbrink R, Kappos L, Uitdehaag BM. MRI characteristics are predictive for CDMS in monofocal, but not in multifocal patients with a clinically isolated syndrome. BMC Neurol. 2009 May 20;9:19.

Barkhof F, Polman CH, Radue EW, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Poppe P, de Vos M, Lasri F, Bauer L, Dahms S, Wagner K, Pohl C, Sandbrink R. Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. Arch Neurol. 2007 Sep;64(9):1292-8.

Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Radu EW, Bauer L, Dahms S, Lanius V, Pohl C, Sandbrink R; BENEFIT Study Group. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007 Aug 4;370(9585):389-97.

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91031, 305207
Study First Received:	September 9, 2005
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00185211 History of Changes
Health Authority:	United States: Food and Drug Administration; Austria: Federal Ministry for Health and Women; Canada: Health Canada; Netherlands: Dutch Health Care Inspectorate; Switzerland: Swissmedic; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Spain: Ministry of Health and Consumption; France: French Data Protection Authority; France: Afssaps - French Health Products Safety Agency; Finland: Finnish Medicines Agency; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Norway: Norwegian Medicines Agency; Portugal: National Pharmacy and Medicines Institute; Poland: Ministry of Health; Sweden: Medical Products Agency; Slovenia: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic

Sclerosis
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 20, 2009