BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00099502
Collaborator
(none)
2,244
199
3
45
11.3
0.3
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Study Type:
Interventional
Actual Enrollment
:
2244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date
:
Nov 1, 2003
Actual Study Completion Date
:
Aug 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1
|
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
|
| Experimental: Arm 2
|
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.
|
Outcome Measures
Primary Outcome Measures
- Hazard ratio for relapses [During the first and during the second 52 weeks]
Secondary Outcome Measures
- Time to confirmed Expanded Disability Status Score (EDSS) progression [After 52 and after 104 weeks]
- Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images [After 104 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35294 | |
| 2 | Cullman | Alabama | United States | 35058 | |
| 3 | Phoenix | Arizona | United States | 85013 | |
| 4 | Tucson | Arizona | United States | 85741-3537 | |
| 5 | Berkeley | California | United States | 94705 | |
| 6 | La Jolla | California | United States | 92037 | |
| 7 | Sacramento | California | United States | 95817 | |
| 8 | San Francisco | California | United States | 94117 | |
| 9 | Englewood | Colorado | United States | 80110 | |
| 10 | Fort Collins | Colorado | United States | 80528 | |
| 11 | Wilmington | Delaware | United States | 19806 | |
| 12 | Washington | District of Columbia | United States | 20037 | |
| 13 | Miami | Florida | United States | 33125 | |
| 14 | Tampa | Florida | United States | 33606-3508 | |
| 15 | Tampa | Florida | United States | 33609 | |
| 16 | Atlanta | Georgia | United States | 30309-1465 | |
| 17 | Augusta | Georgia | United States | 30912 | |
| 18 | Chicago | Illinois | United States | 60637-1470 | |
| 19 | Fort Wayne | Indiana | United States | 46805 | |
| 20 | Indianapolis | Indiana | United States | 46202 | |
| 21 | Des Moines | Iowa | United States | 50314 | |
| 22 | Kansas City | Kansas | United States | 66160 | |
| 23 | Lexington | Kentucky | United States | 40536 | |
| 24 | Louisville | Kentucky | United States | 40202 | |
| 25 | Shreveport | Louisiana | United States | 71130 | |
| 26 | Detroit | Michigan | United States | 48202 | |
| 27 | Duluth | Minnesota | United States | 55805-1984 | |
| 28 | St. Louis | Missouri | United States | 63110 | |
| 29 | Henderson | Nevada | United States | 89052 | |
| 30 | Reno | Nevada | United States | 89557-0035 | |
| 31 | Lebanon | New Hampshire | United States | 03756-0001 | |
| 32 | New Brunswick | New Jersey | United States | 08901 | |
| 33 | Albuquerque | New Mexico | United States | 87131 | |
| 34 | Albany | New York | United States | 12208 | |
| 35 | Mineola | New York | United States | 11501-3987 | |
| 36 | Rochester | New York | United States | 14642 | |
| 37 | Stony Brook | New York | United States | 11794 | |
| 38 | Charlotte | North Carolina | United States | 28203 | |
| 39 | Durham | North Carolina | United States | 27710 | |
| 40 | High Point | North Carolina | United States | 27262 | |
| 41 | Winston-Salem | North Carolina | United States | 27157-1009 | |
| 42 | Cincinnati | Ohio | United States | 45219 | |
| 43 | Columbus | Ohio | United States | 43210-1240 | |
| 44 | Tualatin | Oregon | United States | 97062 | |
| 45 | Philadelphia | Pennsylvania | United States | 19104 | |
| 46 | Philadelphia | Pennsylvania | United States | 19107 | |
| 47 | Pittsburgh | Pennsylvania | United States | 15213-2592 | |
| 48 | Providence | Rhode Island | United States | 02905 | |
| 49 | Charleston | South Carolina | United States | 29425 | |
| 50 | Nashville | Tennessee | United States | 37205 | |
| 51 | Houston | Texas | United States | 77030 | |
| 52 | San Antonio | Texas | United States | 78229 | |
| 53 | Fairfax | Virginia | United States | 22031 | |
| 54 | Seattle | Washington | United States | 98101 | |
| 55 | Tacoma | Washington | United States | 98405 | |
| 56 | Marshfield | Wisconsin | United States | 54449 | |
| 57 | Milwaukee | Wisconsin | United States | 53215 | |
| 58 | Buenos Aires | Capital Federal | Argentina | C1117ABE | |
| 59 | Buenos Aires | Capital Federal | Argentina | C1280AEB | |
| 60 | Rosario | Santa Fe | Argentina | S2000CVB | |
| 61 | Rosario | Santa Fe | Argentina | S2000ZBL | |
| 62 | Buenos Aires | Argentina | C1416CRJ | ||
| 63 | Cordoba | Argentina | X5000HGX | ||
| 64 | Gosford | New South Wales | Australia | 2250 | |
| 65 | Kogarah | New South Wales | Australia | 2217 | |
| 66 | Liverpool | New South Wales | Australia | 2170 | |
| 67 | Melbourne | Victoria | Australia | 3065 | |
| 68 | Parkville | Victoria | Australia | 3050 | |
| 69 | Nedlands | Western Australia | Australia | 6009 | |
| 70 | St. Pölten | Niederösterreich | Austria | 3100 | |
| 71 | Graz | Steiermark | Austria | 8036 | |
| 72 | Innsbruck | Tirol | Austria | 6020 | |
| 73 | Linz | Austria | 4020 | ||
| 74 | Bruxelles - Brussel | Belgium | 1090 | ||
| 75 | Leuven | Belgium | 3000 | ||
| 76 | Melsbroek | Belgium | 1820 | ||
| 77 | Curitiba | Parana | Brazil | 80060-900 | |
| 78 | Recife | PE | Brazil | 52010-040 | |
| 79 | Rio de Janeiro | RJ | Brazil | 21949 900 | |
| 80 | Porto Alegre | RS | Brazil | ||
| 81 | Campinas | Sao Paulo | Brazil | 13081- 970 | |
| 82 | Sao Paulo | SP | Brazil | 05403-900 | |
| 83 | Sao Pulo | SP | Brazil | 05651-901 | |
| 84 | Sao Paulo | Brazil | 04039 | ||
| 85 | Calgary | Alberta | Canada | T2N 2T9 | |
| 86 | Vancouver | British Columbia | Canada | V6T 2B5 | |
| 87 | Winnipeg | Manitoba | Canada | R3A 1R9 | |
| 88 | Halifax | Nova Scotia | Canada | B3H 3A7 | |
| 89 | London | Ontario | Canada | N6A 5A5 | |
| 90 | Mississauga | Ontario | Canada | L5B 1B8 | |
| 91 | Nepean | Ontario | Canada | K2G 6E2 | |
| 92 | Ottawa | Ontario | Canada | K1H 8L6 | |
| 93 | Toronto | Ontario | Canada | M5C 2T2 | |
| 94 | Greenfield Park | Quebec | Canada | J4V 2H1 | |
| 95 | Hull | Quebec | Canada | J8Y 1W7 | |
| 96 | Montreal | Quebec | Canada | H2L 4M1 | |
| 97 | Montreal | Quebec | Canada | H3A 2B4 | |
| 98 | Aarhus C | Denmark | 8000 | ||
| 99 | Oulu | Finland | |||
| 100 | Tampere | Finland | 33521 | ||
| 101 | Rennes | Bretagne | France | 35038 | |
| 102 | Bordeaux | Gironde | France | 33076 | |
| 103 | Caen | France | F-14033 | ||
| 104 | Clermont ferrand | France | 63003 | ||
| 105 | Dijon | France | 21033 | ||
| 106 | Lille | France | 59037 | ||
| 107 | Lyon | France | 69003 | ||
| 108 | Nancy | France | 54035 | ||
| 109 | Nantes | France | 44805 | ||
| 110 | Nice | France | 06000 | ||
| 111 | Nimes | France | 30029 | ||
| 112 | Toulouse | France | 31059 | ||
| 113 | Heidelberg | Baden-Württemberg | Germany | 69112 | |
| 114 | Bayreuth | Bayern | Germany | 95445 | |
| 115 | Regensburg | Bayern | Germany | 93053 | |
| 116 | Hennigsdorf | Brandenburg | Germany | 16761 | |
| 117 | Gießen | Hessen | Germany | 35392 | |
| 118 | Marburg | Hessen | Germany | 35043 | |
| 119 | Offenbach | Hessen | Germany | 63069 | |
| 120 | Greifswald | Mecklenburg-Vorpommern | Germany | 17489 | |
| 121 | Göttingen | Niedersachsen | Germany | 37075 | |
| 122 | Hannover | Niedersachsen | Germany | 30171 | |
| 123 | Hannover | Niedersachsen | Germany | 30625 | |
| 124 | Düsseldorf | Nordrhein-Westfalen | Germany | 40225 | |
| 125 | Essen | Nordrhein-Westfalen | Germany | 45177 | |
| 126 | Münster | Nordrhein-Westfalen | Germany | 48149 | |
| 127 | Asbach | Rheinland-Pfalz | Germany | 53567 | |
| 128 | Halle | Sachsen-Anhalt | Germany | 06120 | |
| 129 | Dresden | Sachsen | Germany | 01307 | |
| 130 | Leipzig | Sachsen | Germany | 04129 | |
| 131 | Berlin | Germany | 13347 | ||
| 132 | Berlin | Germany | 13578 | ||
| 133 | Hamburg | Germany | 20099 | ||
| 134 | Hamburg | Germany | 20251 | ||
| 135 | Athens | Attica | Greece | 11527 | |
| 136 | Athens | Greece | 15127 | ||
| 137 | Thessaloniki | Greece | 546 36 | ||
| 138 | Budapest | Hungary | 1076 | ||
| 139 | Budapest | Hungary | 1145 | ||
| 140 | Györ | Hungary | 9024 | ||
| 141 | Miskolc | Hungary | 3526 | ||
| 142 | Pecs | Hungary | 7623 | ||
| 143 | Zalaegerszeg | Hungary | 8900 | ||
| 144 | Dublin | Dublin 24 | Ireland | ||
| 145 | Cork | Ireland | |||
| 146 | Dublin | Ireland | 7 | ||
| 147 | Dublin | Ireland | 9 | ||
| 148 | Dublin | Ireland | DUBLIN 4 | ||
| 149 | Ashkelon | Israel | 78306 | ||
| 150 | Haifa | Israel | 31048 | ||
| 151 | Haifa | Israel | 34362 | ||
| 152 | Jerusalem | Israel | 91120 | ||
| 153 | Petach Tikva | Israel | 49100 | ||
| 154 | Tel Hashomer | Israel | 52621 | ||
| 155 | Tel-Aviv | Israel | 64239 | ||
| 156 | Zerifin | Israel | 70300 | ||
| 157 | Bari | BA | Italy | 70122 | |
| 158 | Firenze | FI | Italy | 50134 | |
| 159 | Milano | MI | Italy | 20132 | |
| 160 | Padova | PD | Italy | 35128 | |
| 161 | Roma | RO | Italy | 00189 | |
| 162 | Orbassano | TO | Italy | 10043 | |
| 163 | Riga | Latvia | LV-1015 | ||
| 164 | Nijmegen | Gelderland | Netherlands | 6533 PA | |
| 165 | Breda | Netherlands | 4819 EV | ||
| 166 | Sittard | Netherlands | 6131 BK | ||
| 167 | Bergen | Norway | N-5021 | ||
| 168 | Gdansk | Poland | 80-803 | ||
| 169 | Katowice | Poland | 40752 | ||
| 170 | Lodz | Poland | 90-153 | ||
| 171 | Poznan | Poland | 60-355 | ||
| 172 | Warszawa | Poland | 02-097 | ||
| 173 | Warszawa | Poland | 02957 | ||
| 174 | Wroclaw | Poland | 50-417 | ||
| 175 | Moscow | Russian Federation | 117049 | ||
| 176 | Moscow | Russian Federation | 119048 | ||
| 177 | Moskva | Russian Federation | 123367 | ||
| 178 | Moskva | Russian Federation | 127018 | ||
| 179 | Moskva | Russian Federation | 129110 | ||
| 180 | Nizhny Novogorod | Russian Federation | 603076 | ||
| 181 | Novosibirsk | Russian Federation | 630007 | ||
| 182 | Sankt-Peterburg | Russian Federation | 194044 | ||
| 183 | Sankt-Peterburg | Russian Federation | 197376 | ||
| 184 | St. Petersburg | Russian Federation | 197022 | ||
| 185 | Yaroslavl | Russian Federation | 150039 | ||
| 186 | Ljubljana | Slovenia | 1000 | ||
| 187 | Maribor | Slovenia | 2000 | ||
| 188 | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 | |
| 189 | Málaga | Spain | 29010 | ||
| 190 | Sevilla | Spain | 41071 | ||
| 191 | Helsingborg | Sweden | 25278 | ||
| 192 | Stockholm | Sweden | 182 88 | ||
| 193 | Uppsala | Sweden | 75185 | ||
| 194 | Bern | Switzerland | 3010 | ||
| 195 | St. Gallen | Switzerland | 9007 | ||
| 196 | Donetsk | Ukraine | 83003 | ||
| 197 | Kharkiv | Ukraine | 61068 | ||
| 198 | Kiev | Ukraine | 03110 | ||
| 199 | Lviv | Ukraine | 79000 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00099502
Other Study ID Numbers:
- 91162
- EudraCT: 2005-002235-27
- 306440
- Beyond
- NCT00185432
First Posted:
Dec 16, 2004
Last Update Posted:
Dec 19, 2008
Last Verified:
Dec 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: