BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients

December 18, 2008 updated by: Bayer

International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.

The purpose of this study is to determine

  • whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms
  • whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1416CRJ
      • Cordoba, Argentina, X5000HGX
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1280AEB
      • Buenos Aires, Capital Federal, Argentina, C1117ABE
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CVB
      • Rosario, Santa Fe, Argentina, S2000ZBL
  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
      • Kogarah, New South Wales, Australia, 2217
      • Liverpool, New South Wales, Australia, 2170
    • Victoria
      • Melbourne, Victoria, Australia, 3065
      • Parkville, Victoria, Australia, 3050
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Austria
      • Linz, Austria, 4020
    • Niederösterreich
      • St. Pölten, Niederösterreich, Austria, 3100
    • Steiermark
      • Graz, Steiermark, Austria, 8036
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Belgium
      • Bruxelles - Brussel, Belgium, 1090
      • Leuven, Belgium, 3000
      • Melsbroek, Belgium, 1820
  • Brazil
      • Sao Paulo, Brazil, 04039
    • PE
      • Recife, PE, Brazil, 52010-040
    • Parana
      • Curitiba, Parana, Brazil, 80060-900
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21949 900
    • RS
      • Porto Alegre, RS, Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-900
      • Sao Pulo, SP, Brazil, 05651-901
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13081- 970
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Mississauga, Ontario, Canada, L5B 1B8
      • Nepean, Ontario, Canada, K2G 6E2
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5C 2T2
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hull, Quebec, Canada, J8Y 1W7
      • Montreal, Quebec, Canada, H3A 2B4
      • Montreal, Quebec, Canada, H2L 4M1
  • Denmark
      • Aarhus C, Denmark, 8000
  • Finland
      • Oulu, Finland
      • Tampere, Finland, 33521
  • France
      • Caen, France, F-14033
      • Clermont ferrand, France, 63003
      • Dijon, France, 21033
      • Lille, France, 59037
      • Lyon, France, 69003
      • Nancy, France, 54035
      • Nantes, France, 44805
      • Nice, France, 06000
      • Nimes, France, 30029
      • Toulouse, France, 31059
    • Bretagne
      • Rennes, Bretagne, France, 35038
    • Gironde
      • Bordeaux, Gironde, France, 33076
  • Germany
      • Berlin, Germany, 13347
      • Berlin, Germany, 13578
      • Hamburg, Germany, 20099
      • Hamburg, Germany, 20251
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69112
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
      • Regensburg, Bayern, Germany, 93053
    • Brandenburg
      • Hennigsdorf, Brandenburg, Germany, 16761
    • Hessen
      • Gießen, Hessen, Germany, 35392
      • Marburg, Hessen, Germany, 35043
      • Offenbach, Hessen, Germany, 63069
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
      • Hannover, Niedersachsen, Germany, 30625
      • Hannover, Niedersachsen, Germany, 30171
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Essen, Nordrhein-Westfalen, Germany, 45177
      • Münster, Nordrhein-Westfalen, Germany, 48149
    • Rheinland-Pfalz
      • Asbach, Rheinland-Pfalz, Germany, 53567
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04129
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
  • Greece
      • Athens, Greece, 15127
      • Thessaloniki, Greece, 546 36
    • Attica
      • Athens, Attica, Greece, 11527
  • Hungary
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1076
      • Györ, Hungary, 9024
      • Miskolc, Hungary, 3526
      • Pecs, Hungary, 7623
      • Zalaegerszeg, Hungary, 8900
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland, 9
      • Dublin, Ireland, 7
      • Dublin, Ireland, DUBLIN 4
    • Dublin 24
      • Dublin, Dublin 24, Ireland
  • Israel
      • Ashkelon, Israel, 78306
      • Haifa, Israel, 31048
      • Haifa, Israel, 34362
      • Jerusalem, Israel, 91120
      • Petach Tikva, Israel, 49100
      • Tel Hashomer, Israel, 52621
      • Tel-Aviv, Israel, 64239
      • Zerifin, Israel, 70300
  • Italy
    • BA
      • Bari, BA, Italy, 70122
    • FI
      • Firenze, FI, Italy, 50134
    • MI
      • Milano, MI, Italy, 20132
    • PD
      • Padova, PD, Italy, 35128
    • RO
      • Roma, RO, Italy, 00189
    • TO
      • Orbassano, TO, Italy, 10043
  • Latvia
      • Riga, Latvia, LV-1015
  • Netherlands
      • Breda, Netherlands, 4819 EV
      • Sittard, Netherlands, 6131 BK
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6533 PA
  • Norway
      • Bergen, Norway, N-5021
  • Poland
      • Gdansk, Poland, 80-803
      • Katowice, Poland, 40752
      • Lodz, Poland, 90-153
      • Poznan, Poland, 60-355
      • Warszawa, Poland, 02-097
      • Warszawa, Poland, 02957
      • Wroclaw, Poland, 50-417
  • Russian Federation
      • Moscow, Russian Federation, 117049
      • Moscow, Russian Federation, 119048
      • Moskva, Russian Federation, 123367
      • Moskva, Russian Federation, 127018
      • Moskva, Russian Federation, 129110
      • Nizhny Novogorod, Russian Federation, 603076
      • Novosibirsk, Russian Federation, 630007
      • Sankt-Peterburg, Russian Federation, 194044
      • Sankt-Peterburg, Russian Federation, 197376
      • St. Petersburg, Russian Federation, 197022
      • Yaroslavl, Russian Federation, 150039
  • Slovenia
      • Ljubljana, Slovenia, 1000
      • Maribor, Slovenia, 2000
  • Spain
      • Málaga, Spain, 29010
      • Sevilla, Spain, 41071
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Sweden
      • Helsingborg, Sweden, 25278
      • Stockholm, Sweden, 182 88
      • Uppsala, Sweden, 75185
  • Switzerland
      • Bern, Switzerland, 3010
      • St. Gallen, Switzerland, 9007
  • Ukraine
      • Donetsk, Ukraine, 83003
      • Kharkiv, Ukraine, 61068
      • Kiev, Ukraine, 03110
      • Lviv, Ukraine, 79000
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Cullman, Alabama, United States, 35058
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Tucson, Arizona, United States, 85741-3537
    • California
      • Berkeley, California, United States, 94705
      • La Jolla, California, United States, 92037
      • Sacramento, California, United States, 95817
      • San Francisco, California, United States, 94117
    • Colorado
      • Englewood, Colorado, United States, 80110
      • Fort Collins, Colorado, United States, 80528
    • Delaware
      • Wilmington, Delaware, United States, 19806
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Miami, Florida, United States, 33125
      • Tampa, Florida, United States, 33609
      • Tampa, Florida, United States, 33606-3508
    • Georgia
      • Atlanta, Georgia, United States, 30309-1465
      • Augusta, Georgia, United States, 30912
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Duluth, Minnesota, United States, 55805-1984
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nevada
      • Henderson, Nevada, United States, 89052
      • Reno, Nevada, United States, 89557-0035
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Albany, New York, United States, 12208
      • Mineola, New York, United States, 11501-3987
      • Rochester, New York, United States, 14642
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
      • Durham, North Carolina, United States, 27710
      • High Point, North Carolina, United States, 27262
      • Winston-Salem, North Carolina, United States, 27157-1009
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Columbus, Ohio, United States, 43210-1240
    • Oregon
      • Tualatin, Oregon, United States, 97062
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15213-2592
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Fairfax, Virginia, United States, 22031
    • Washington
      • Seattle, Washington, United States, 98101
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female and male patients
  • Aged 18-55 years
  • Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0
  • Treatment-naive to IFNB or Copaxone

Exclusion Criteria:

  • Neurological progression at disease onset or between relapses
  • Serious or acute heart diseases
  • History of severe depression or suicide attempt
  • Serious or acute liver, renal or bone marrow dysfunction
  • Monoclonal gammopathy
  • Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
Experimental: Arm 2
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
Active Comparator: Arm 3
Drug: Copaxone
20 mg administered s.c. once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hazard ratio for relapses
Time Frame: During the first and during the second 52 weeks
During the first and during the second 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to confirmed Expanded Disability Status Score (EDSS) progression
Time Frame: After 52 and after 104 weeks
After 52 and after 104 weeks
Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images
Time Frame: After 104 weeks
After 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91162
  • BEYOND (Company internal)
  • EudraCT: 2005-002235-27
  • 306440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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