BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose (Beyond)

April 3, 2015 updated by: Bayer

International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg

The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.

Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)

Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.

The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.

Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.

Study Type

Interventional

Enrollment (Actual)

1420

Phase

  • 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
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1280AEB
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1117ABE
    • Córdoba
      • Cordoba, Córdoba, Argentina, X5000HGX
    • Santa Fe
      • Rosario, Santa Fe, Argentina
      • Rosario, Santa Fe, Argentina, S2000ZBL
  • Australia
      • Liverpool, Australia, NSW 2170
      • Wyoming, Australia, NSW 2250
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
      • Parkville, Victoria, Australia, 3050
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Austria
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
      • Linz, Austria, 4020
    • Niederösterreich
      • St Poelten, Niederösterreich, Austria, A-3100
  • Belgium
      • Brussel, Belgium, 1090
      • Leuven, Belgium, 3000
      • Melsbroek, Belgium, 1820
  • Brazil
      • Rio de Janeiro, Brazil, 21941-590
      • Sao Paulo, Brazil, 05403-900
      • Sao Paulo, Brazil, 01221-020
      • Sao Paulo, Brazil, 04039-032
    • Parana
      • Curitiba, Parana, Brazil, 80240-340
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52010-040
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13081- 970
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Mississauga, Ontario, Canada, L5B 1B8
      • Nepean, Ontario, Canada, K2G 6E2
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hull, Quebec, Canada, J8Y 1W7
      • Montreal, Quebec, Canada, H3A 2B4
      • Montreal, Quebec, Canada, H2L 4M1
  • Denmark
      • Aarhus, Denmark, 8000
  • Finland
      • Oulu, Finland, 90029
      • Tampere, Finland, 33521
  • France
      • Clermont ferrand, France, 63003
      • Dijon, France, 21033
      • Lille, France, 59037
      • Nancy, France, 54035
      • Nantes, France, 44093
      • 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, 13585
      • Hamburg, Germany, 20246
      • Hamburg, Germany, 20099
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
      • Regensburg, Bayern, Germany, 93053
    • Brandenburg
      • Hennigsdorf, Brandenburg, Germany, 16761
    • Hessen
      • Gießen, Hessen, Germany, 35392
      • Marburg, Hessen, Germany, 35039
      • Offenbach, Hessen, Germany, 63069
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37099
      • Hannover, Niedersachsen, Germany, 30625
      • Hannover, Niedersachsen, Germany, 30559
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Essen, Nordrhein-Westfalen, Germany, 45117
      • Münster, Nordrhein-Westfalen, Germany, 48149
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04129
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
  • Greece
      • Thessaloniki, Greece, 54636
    • Attica
      • Athens, Attica, Greece, 11527
  • Hungary
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1076
      • Györ, Hungary, 9024
      • Miskolc, Hungary, 3501
      • Pecs, Hungary, 7623
      • Zalaegerszeg-Pozva, Hungary, H-8900
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland, 4
      • Dublin, Ireland, 9
      • Dublin, Ireland
  • Israel
      • Ashkelon, Israel, 78278
      • Haifa, Israel, 31048
      • Jerusalem, Israel, 91120
      • Tel Hashomer, Israel, 52621
      • Tel-Aviv, Israel, 64239
      • Zerifin, Israel, 70300
  • Italy
      • Bari, Italy, 70122
      • Firenze, Italy, 50134
      • Milano, Italy, 20132
      • Padova, Italy, 35128
      • Roma, Italy, 00189
    • Torino
      • Orbassano, Torino, Italy, 10043
  • Latvia
      • Riga, Latvia, LV-1015
  • Netherlands
      • Breda, Netherlands, 4819 EV
      • Nijmegen, Netherlands, 6533 PA
      • Sittard, Netherlands, 6131 BK
  • Norway
      • Bergen, Norway, N-5021
  • Poland
      • Gdansk, Poland, 80-803
      • Katowice, Poland, 40752
      • Lodz, Poland, 90153
      • Poznan, Poland, 61848
      • Warszawa, Poland, 02957
      • Warszawa, Poland, 02097
      • Wroclaw, Poland, 50420
  • Russian Federation
      • Moskva, Russian Federation, 123367
      • Moskva, Russian Federation, 127018
      • Moskva, Russian Federation, 129110
      • Moskva, Russian Federation, 117049
      • Moskva, Russian Federation, 118089
      • Nizhy Novgorod, Russian Federation, 603076
      • Novosibirsk, Russian Federation, 630007
      • Sankt-Peterburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 194044
      • St. Petersburg, Russian Federation, 197376
      • Yaroslavl, Russian Federation, 150039
  • Slovenia
      • Ljubljana, Slovenia, SI-1525
      • Maribor, Slovenia, 2000
  • Spain
      • Malaga, Spain, 29010
      • Sevilla, Spain, 41071
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Sweden
      • Stockholm, Sweden, 182 88
      • Uppsala, Sweden, 751 85
  • 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, 35294-7340
      • Cullman, Alabama, United States, 35058
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Tucson, Arizona, United States, 85741
    • California
      • Berkeley, California, United States, 94705
      • La Jolla, California, United States, 92037
      • Sacramento, California, United States, 95817
      • San Francisco, California, United States, 94117
    • Colorado
      • Fort Collins, Colorado, United States, 80528
    • Delaware
      • Newark, Delaware, United States, 19713
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Maitland, Florida, United States, 32751
      • Miami, Florida, United States, 33136
      • Tampa, Florida, United States, 33609
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30309-1465
      • Augusta, Georgia, United States, 30912
    • Illinois
      • Chicago, Illinois, United States, 60637
    • 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
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Duluth, Minnesota, United States, 55805
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nevada
      • Henderson, Nevada, United States, 89052
      • Reno, Nevada, United States, 89509
    • New Jersey
      • Newark, New Jersey, United States, 07103
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5281
    • New York
      • Mineola, New York, United States, 11501
      • Rochester, New York, United States, 14642
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
      • Durham, North Carolina, United States, 27710
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Columbus, Ohio, United States, 43210
    • Oregon
      • Tualatin, Oregon, United States, 97062
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
    • 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
      • 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

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completion of the BEYOND study 306440 as scheduled
  • Relapsing multiple sclerosis
  • Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.

  • Females of child-bearing potential:

    • Agreement to practice adequate contraception methods and
    • Negative pregnancy test and
    • No lactation
  • Written informed consent

Exclusion Criteria:

  • Serious or acute heart diseases
  • History of severe depression or suicide attempt
  • Epilepsy not adequately controlled by treatment
  • Known allergy to IFNs, to human albumin or to mannitol
  • Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IFNB-1b 500 mcg
Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.

Phase B: All patients will receive 500µg s.c.every other day (open-label).
EXPERIMENTAL: IFNB-1b 250 mcg
Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.

Phase B: All patients will receive 500µg s.c.every other day (open-label).
EXPERIMENTAL: IFNB-1b 250 mcg*

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.

Phase B: All patients will receive 500µg s.c.every other day (open-label).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flu-like-syndrome
Time Frame: 309 days
The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
309 days
Injection-site Reactions
Time Frame: 309 days
The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
309 days
Liver Enzyme Elevations
Time Frame: 309 days
The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
309 days
Hematological Abnormalities
Time Frame: 309 days
The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
309 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
Time Frame: 309 days
Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.
309 days

Collaborators and Investigators

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

Sponsor

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

May 1, 2007

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (ESTIMATE)

April 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91656
  • 2006-005270-47 (EUDRACT_NUMBER)
  • 309363 (OTHER: Company internal)

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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