TOP: Tysabri Observational Program
Sponsor
Biogen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00493298
Collaborator
(none)
6,620
422
258.2
15.7
0.1
Study Details
Study Description
Brief Summary
The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of natalizumab in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.
Study Design
Study Type:
Observational
Actual Enrollment
:
6620 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
TOP: Tysabri® Observational Program
Actual Study Start Date
:
Jun 29, 2007
Anticipated Primary Completion Date
:
Jan 3, 2029
Anticipated Study Completion Date
:
Jan 3, 2029
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| natalizumab According to the local prescribing information |
Drug: natalizumab
According to the local prescribing information
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of participants with serious adverse events (SAE) [Up to 15 years]
Secondary Outcome Measures
- Annualized Relapse Rate (ARR) [Yearly for up to 15 years]
A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. New or recurrent neurological symptoms that occur less than 30 days following the onset of a protocol-defined relapse should be considered part of the same relapse.
- Distribution of the total number of relapses [Yearly for up to 15 years]
- Time to first relapse [Yearly for up to 15 years]
- Percentage of participants with relapse [Yearly for up to 15 years]
- Percentage of participants with disability progression [Yearly for up to 15 years]
Disability progression is defined as at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from Baseline that is sustained over 6 months. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
- Percentage of participants that reach Expanded Disability Status Score (EDSS) milestones indicating increasing disability [Yearly for up to 15 years]
The percentage of participants that reach EDSS milestones such as 4.0, 6.0, and 7.0 sustained after 6 months. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
- Percentage of participants whose EDSS worsened, stabilized or improved and sustained over 6 months [Yearly for up to 15 years]
- Evaluation of baseline disease characteristics as prognostic indicators for disease activity and disability progression over time [Yearly for up to 15 years]
Baseline disease characteristics evaluated will include: EDSS; Disease duration at baseline; Number of relapses during 1 and 2 years before baseline; Previous use of disease modifying therapy; Age, gender.
- Evaluation of short-term (1 year) disease outcomes as prognostic indicators for disease activity and disability progression over time [Yearly for up to 15 years]
Short term outcomes evaluated will include: EDSS progression during first 12 months; Occurrence of relapses during first 12 months
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Documented diagnosis of Relapsing Remitting Multiple Sclerosis
-
The decision to treat with Tysabri must precede enrollment
-
Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
-
Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri
Key Exclusion Criteria:
-
History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
-
History of positive anti-natalizumab antibodies
-
Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
-
Patient immunocompromised at the time of enrollment
-
Known active malignancy
-
Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Buenos Aires | Argentina | 8000 | |
| 2 | Research Site | Buenos Aires | Argentina | C1061ABD | |
| 3 | Research Site | Buenos Aires | Argentina | C1118AAT | |
| 4 | Research Site | Buenos Aires | Argentina | C1428AQK | |
| 5 | Research Site | CABA, Buenos Aires | Argentina | C1015ABR | |
| 6 | Research Site | Cordoba | Argentina | X5014HYR | |
| 7 | Research site | Santa Fe | Argentina | S2000BZL | |
| 8 | Research site | Camperdown | New South Wales | Australia | 2050 |
| 9 | Research site | Liverpool | New South Wales | Australia | 2170 |
| 10 | Research site | New Lambton Heights | New South Wales | Australia | 2305 |
| 11 | Research Site | St. Leonards | New South Wales | Australia | 2065 |
| 12 | Research Site | Auchenflower | Queensland | Australia | 4066 |
| 13 | Research site | Gold Coast | Queensland | Australia | 9726 |
| 14 | Research site | Adelaide | South Australia | Australia | 5042 |
| 15 | Research Site | North Adelaide | South Australia | Australia | 5006 |
| 16 | Research site | Box Hill | Victoria | Australia | 3128 |
| 17 | Research site | Fitzroy | Victoria | Australia | 3065 |
| 18 | Research site | Heidelberg | Victoria | Australia | 3084 |
| 19 | Research Site | Melbourne | Victoria | Australia | 3004 |
| 20 | Research site | Parkville | Victoria | Australia | 3050 |
| 21 | Research site | Nedlands | Western Australia | Australia | 6009 |
| 22 | Research site | Aalst | Belgium | 9300 | |
| 23 | Research site | Antwerpen | Belgium | 2020 | |
| 24 | Research site | Bocholt | Belgium | 3950 | |
| 25 | Research site | Brasschaat | Belgium | 2930 | |
| 26 | Research site | Brugge | Belgium | 8000 | |
| 27 | Research site | Brussel (Jette) | Belgium | 1090 | |
| 28 | Research site | Brussel | Belgium | 1000 | |
| 29 | Research site | Brussel | Belgium | 1180 | |
| 30 | Research site | Bruxelles (Anderlecht) | Belgium | 1070 | |
| 31 | Research site | Charleroi | Belgium | 6000 | |
| 32 | Research Site | Charleroi | Belgium | B-6042 | |
| 33 | Research site | Edegem | Belgium | 2650 | |
| 34 | Research site | Fraiture | Belgium | 4557 | |
| 35 | Research site | Genk | Belgium | 3600 | |
| 36 | Research site | Gent | Belgium | 9000 | |
| 37 | Research site | Hasselt | Belgium | 3500 | |
| 38 | Research site | Kortrijk | Belgium | 8500 | |
| 39 | Research site | La Louviere | Belgium | 7100 | |
| 40 | Research site | Leuven | Belgium | 3000 | |
| 41 | Research site | Libramont | Belgium | 6800 | |
| 42 | Research site | Liège | Belgium | 4000 | |
| 43 | Research site | Malmedy | Belgium | 4960 | |
| 44 | Research site | Melsbroek | Belgium | 1820 | |
| 45 | Research site | Oostende | Belgium | 8400 | |
| 46 | Research site | Ottignies | Belgium | 1340 | |
| 47 | Research Site | Overpelt | Belgium | 3900 | |
| 48 | Research site | Sijsele | Belgium | 8340 | |
| 49 | Research site | Tournai | Belgium | 7500 | |
| 50 | Research site | Wilrijk | Belgium | 2610 | |
| 51 | Research site | Woluwe-Saint-Lambert | Belgium | 1200 | |
| 52 | Research Site | Belo Horizonte | Brazil | 30130-090 | |
| 53 | Research Site | Botucatu | Brazil | 18618-687 | |
| 54 | Research Site | Rio de Janeiro | Brazil | 21941-590 | |
| 55 | Research Site | Sao Paulo | Brazil | 05402-000 | |
| 56 | Research Site | Sao Paulo | Brazil | 2151-1233 | |
| 57 | Research site | Edmonton | Alberta | Canada | T5H 4B9 |
| 58 | Research site | Burnaby | British Columbia | Canada | V5G2X6 |
| 59 | Research Site | Vancouver | British Columbia | Canada | V6T 2B5 |
| 60 | Research site | Winnipeg | Manitoba | Canada | R3E0T5 |
| 61 | Research site | Saint John | New Brunswick | Canada | E2L 4L2 |
| 62 | Research site | Halifax | Nova Scotia | Canada | B3HIV7 |
| 63 | Research site | Bracebridge | Ontario | Canada | P1L 1R1 |
| 64 | Research site | Guelph | Ontario | Canada | N1H4J4 |
| 65 | Research site | Hamilton | Ontario | Canada | L8L5G4 |
| 66 | Research site | Hamilton | Ontario | Canada | L8N 1T8 |
| 67 | Research site | London | Ontario | Canada | N6A5A5 |
| 68 | Research site | Milton | Ontario | Canada | L9T 7H3 |
| 69 | Research site | Thunder Bay | Ontario | Canada | P7B7C7 |
| 70 | Research site | Toronto | Ontario | Canada | M5B 1W8 |
| 71 | Research site | Gatineau | Quebec | Canada | J8Y 1W2 |
| 72 | Research site | Greenfield Park | Quebec | Canada | J4V 2J2 |
| 73 | Research site | Montreal | Quebec | Canada | H3A 2B4 |
| 74 | Research site | Montréal | Quebec | Canada | H2X OA9 |
| 75 | Research site | Regina | Saskatchewan | Canada | S4S3K8 |
| 76 | Research site | Brno | Czechia | 62500 | |
| 77 | Research site | Brno | Czechia | 65691 | |
| 78 | Research site | Ceské Budejovice | Czechia | 37087 | |
| 79 | Research site | Hradec Kralové | Czechia | 50005 | |
| 80 | Research site | Jihlava | Czechia | 58633 | |
| 81 | Research site | Olomouc | Czechia | 77520 | |
| 82 | Research site | Ostrava | Czechia | 70852 | |
| 83 | Research site | Pardubice | Czechia | 53203 | |
| 84 | Research site | Plzen | Czechia | 30460 | |
| 85 | Research site | Prague 10 | Czechia | 10034 | |
| 86 | Research site | Prague 4 | Czechia | 14200 | |
| 87 | Research site | Prague | Czechia | 12808 | |
| 88 | Research site | Praha 5 | Czechia | 15006 | |
| 89 | Research site | Teplice | Czechia | 41528 | |
| 90 | Research Site | Teplice | Czechia | 41529 | |
| 91 | Research site | Zlín | Czechia | 76275 | |
| 92 | Research site | Helsinki | Finland | 00029 | |
| 93 | Research site | Jyväskylä | Finland | 40620 | |
| 94 | Research site | Kuopio | Finland | 70211 | |
| 95 | Research site | Pori | Finland | 28500 | |
| 96 | Research site | Seinäjoki | Finland | 60220 | |
| 97 | Research site | Tampere | Finland | 33521 | |
| 98 | Research site | Turku | Finland | 20521 | |
| 99 | Research site | Agen Cedex 9 | France | 47923 | |
| 100 | Research site | Aix En Provence Cedex 1 | France | 13100 | |
| 101 | Research site | Alencon Cedex | France | 61014 | |
| 102 | Research site | Angouleme | France | 16000 | |
| 103 | Research site ,1 Allée du Château- Dr Wagner | Ars-Laquenexy | France | 57245 | |
| 104 | Research site | Auxerre Cedex | France | 89011 | |
| 105 | Research site | Avranches Cedex | France | 50300 | |
| 106 | Research site | Bayonne Cedex | France | 64100 | |
| 107 | Research site | Beauvais Cedex | France | 60000 | |
| 108 | Research site | Belfort Cedex | France | 90000 | |
| 109 | Research site | Bethune Cedex | France | 62408 | |
| 110 | Research site | Beuvry | France | 62660 | |
| 111 | Research site | Boulogne sur mer cedex | France | 62321 | |
| 112 | Research site | Calais Cedex | France | 62107 | |
| 113 | Research site | Castelnau Le Lez Cedex | France | 34171 | |
| 114 | Research site | Castres Cedex | France | 81108 | |
| 115 | Research site | Chambery Cedex | France | 73000 | |
| 116 | Research site | Chambery cedex | France | 73011 | |
| 117 | Research site | Colmar Cedex | France | 68024 | |
| 118 | Research site | Compiegne Cedex | France | 60321 | |
| 119 | Research site | Dieppe | France | 76200 | |
| 120 | Research site | Dreux Cedex | France | 28107 | |
| 121 | Research site | Dunkerque cedex 1 | France | 59385 | |
| 122 | Research site | Epinal cedex | France | 88021 | |
| 123 | Research site | Haguenau cedex | France | 67501 | |
| 124 | Research site | La Rochelle Cedex 1 | France | 17000 | |
| 125 | Research site 177, rue de Versailles- Dr Servan | Le Chesnay Cedex | France | 78157 | |
| 126 | Research site | Le Chesnay Cedex | France | 78157 | |
| 127 | Research site | Le Coudray | France | 28630 | |
| 128 | Research site | Le Havre | France | 76600 | |
| 129 | Research site | Le Mans | France | 72037 | |
| 130 | Research site | Lille | France | 59000 | |
| 131 | Research site | Lisieux Cedex | France | 14100 | |
| 132 | Research site | Lomme Cedex | France | 59462 | |
| 133 | Research site | Mantes La Jolie Cedex | France | 78201 | |
| 134 | Research site | Maubeuge Cedex | France | 59600 | |
| 135 | Research site | Metz Cedex 01 | France | 57038 | |
| 136 | Research site | Metz Tessy | France | 74370 | |
| 137 | Research site | Mont De Marsan Cedex | France | 40024 | |
| 138 | Research site | Montauban Cedex | France | 82000 | |
| 139 | Research site | Montlucon | France | 03100 | |
| 140 | Research site | Montpellier | France | 34080 | |
| 141 | Research site | Montpellier | France | 34264 | |
| 142 | Research site | Mulhouse Cedex | France | 68100 | |
| 143 | Research site | Nice Cedex 2 | France | 06105 | |
| 144 | Research site | Paris cedex 14 | France | 75674 | |
| 145 | Research site | Paris | France | 75020 | |
| 146 | Research site | Pau Cedex | France | 64000 | |
| 147 | Research site | PAU | France | 64000 | |
| 148 | Research site | Quimper Cedex | France | 29000 | |
| 149 | Research site | Reims | France | 51100 | |
| 150 | Research site | Sarreguemines | France | 57200 | |
| 151 | Research site | Saumur Cedex | France | 49400 | |
| 152 | Research site | St Aubin Sur Scie | France | 76550 | |
| 153 | Research site | St Malo Cedex | France | 35400 | |
| 154 | Research site | Talant | France | 21240 | |
| 155 | Research site | Tarbes Cedex 9 | France | 65013 | |
| 156 | Research site | Tarbes | France | 65013 | |
| 157 | Research site | Tourcoing Cedex | France | 59200 | |
| 158 | Research site | Trappes | France | 78190 | |
| 159 | Research site | Trelaze | France | 49800 | |
| 160 | Research site | Trélazé | France | 49800 | |
| 161 | Research site | Valenciennes Cedex | France | 59322 | |
| 162 | Research site | Vesoul Cedex | France | 70014 | |
| 163 | Research site | Vichy cedex | France | 3201 | |
| 164 | Research site | Évreux | France | 27015 | |
| 165 | Research site | Abensberg | Germany | 93326 | |
| 166 | Research site | Andernach | Germany | 56626 | |
| 167 | Research Site | Arnsdorf | Germany | 01477 | |
| 168 | Research site | Asperg | Germany | 71679 | |
| 169 | Research site | Augsburg | Germany | 86156 | |
| 170 | Research site | Bad Hersfeld | Germany | 36088 | |
| 171 | Research site | Bad Honnef | Germany | 53604 | |
| 172 | Research Site | Bad Kissingen | Germany | 97688 | |
| 173 | Research site | Bad Mergentheim | Germany | 97980 | |
| 174 | Research site | Bad Reichenhall | Germany | 83435 | |
| 175 | Research site | Bamberg | Germany | 96049 | |
| 176 | Research site | Berlin-Tegel | Germany | 13507 | |
| 177 | Research site | Berlin | Germany | 10017 | |
| 178 | Research site | Berlin | Germany | 10437 | |
| 179 | Research site | Berlin | Germany | 10785 | |
| 180 | Research site | Berlin | Germany | 10969 | |
| 181 | Research site | Berlin | Germany | 12057 | |
| 182 | Research site | Berlin | Germany | 12099 | |
| 183 | Research site | Berlin | Germany | 12203 | |
| 184 | Research site | Berlin | Germany | 13347 | |
| 185 | Research site | Berlin | Germany | 13439 | |
| 186 | Research site | Berlin | Germany | 14163 | |
| 187 | Research site | Bielefeld | Germany | 33602 | |
| 188 | Research site | Bielefeld | Germany | 33647 | |
| 189 | Research site | Bochum | Germany | 44791 | |
| 190 | Research site | Bogen | Germany | 94327 | |
| 191 | Research site | Bonn | Germany | 53111 | |
| 192 | Research site | Bruchsal | Germany | 76646 | |
| 193 | Research site | Buchholz | Germany | 21244 | |
| 194 | Research site | Celle | Germany | 29223 | |
| 195 | Research site | Chemnitz | Germany | 09117 | |
| 196 | Research site | Dillingen | Germany | 66763 | |
| 197 | Research site | Dresden | Germany | 01067 | |
| 198 | Research site | Duisburg | Germany | 47169 | |
| 199 | Research site | Düren | Germany | 52351 | |
| 200 | Research site | Düsseldorf | Germany | 40211 | |
| 201 | Research site | Düsseldorf | Germany | 40225 | |
| 202 | Research site | Eisenach | Germany | 99817 | |
| 203 | Research site | Emden | Germany | 26721 | |
| 204 | Research site | Emmendingen | Germany | 79312 | |
| 205 | Research site | Erbach | Germany | 64711 | |
| 206 | Research site | Erlangen | Germany | 91054 | |
| 207 | Research site | Essen | Germany | 45122 | |
| 208 | Research site | Essen | Germany | 45138 | |
| 209 | Research site | Essen | Germany | 45257 | |
| 210 | Research site | Falkenstein | Germany | 61462 | |
| 211 | Research site | Frankfurt | Germany | 60325 | |
| 212 | Research site | Freiburg | Germany | 79106 | |
| 213 | Research site | Greifswald | Germany | 17489 | |
| 214 | Research site | Görlitz | Germany | 02828 | |
| 215 | Research site | Göttingen | Germany | 37073 | |
| 216 | Research site | Halle | Germany | 06120 | |
| 217 | Research site | Hamburg | Germany | 20249 | |
| 218 | Research site | Hamburg | Germany | 20354 | |
| 219 | Research site | Hamburg | Germany | 22179 | |
| 220 | Research site | Heidelberg | Germany | 69120 | |
| 221 | Research site | Herford | Germany | 32052 | |
| 222 | Research site | Itzehoe | Germany | 25524 | |
| 223 | Research site | Jena | Germany | 07740 | |
| 224 | Research site | Kaiserslautern | Germany | 67655 | |
| 225 | Research site | Kaltenkirchen | Germany | 24568 | |
| 226 | Research site | Kandel | Germany | 76870 | |
| 227 | Research site | Kassel | Germany | 34121 | |
| 228 | Research site | Kastellaun | Germany | 56288 | |
| 229 | Research site | Kirchberg | Germany | 08107 | |
| 230 | Research site | Kirchheim unter Teck | Germany | 73230 | |
| 231 | Research Site | Kreuzau | Germany | 52372 | |
| 232 | Research site | Köln | Germany | 50924 | |
| 233 | Research site | Köln | Germany | 50996 | |
| 234 | Research site | Ladenburg | Germany | 68526 | |
| 235 | Research site | Leipzig | Germany | 041579 | |
| 236 | Research site | Leipzig | Germany | 04275 | |
| 237 | Research site | Lengerich | Germany | 49525 | |
| 238 | Research site | Ludwigshafen | Germany | 67059 | |
| 239 | Research site | Lüdenscheid | Germany | 58511 | |
| 240 | Research site | Lüdenscheid | Germany | 58515 | |
| 241 | Research site | Lüneburg | Germany | 21335 | |
| 242 | Research site | Magdeburg | Germany | 39120 | |
| 243 | Research site | Mannheim | Germany | 68158 | |
| 244 | Research site | Mannheim | Germany | 68161 | |
| 245 | Research site | Marburg | Germany | 35043 | |
| 246 | Research site | München | Germany | 80331 | |
| 247 | Research site | München | Germany | 80333 | |
| 248 | Research site | München | Germany | 81479 | |
| 249 | Research site | München | Germany | 81675 | |
| 250 | Research site | München | Germany | 81825 | |
| 251 | Research site | Münster | Germany | 48149 | |
| 252 | Research site | Neuburg | Germany | 86633 | |
| 253 | Research site | Neukirchen-Vluyn | Germany | 47506 | |
| 254 | Research site | Neuruppin | Germany | 16816 | |
| 255 | Research site | Nürnberg | Germany | 90419 | |
| 256 | Research site | Nürnberg | Germany | 90451 | |
| 257 | Research site | Nürnberg | Germany | 90461 | |
| 258 | Research site | Oldenburg | Germany | 26121 | |
| 259 | Research site | Oldenburg | Germany | 26127 | |
| 260 | Research site | Olpe | Germany | 57462 | |
| 261 | Research site | Osnabrück | Germany | 49074 | |
| 262 | Research site | Osnabrück | Germany | 49076 | |
| 263 | Research site | Osnabrück | Germany | 49078 | |
| 264 | Research site | Paderborn | Germany | 33098 | |
| 265 | Research site | Potsdam | Germany | 14471 | |
| 266 | Research site | Regensburg | Germany | 93053 | |
| 267 | Research site | Remscheid | Germany | 42853 | |
| 268 | Research site | Rüdersdorf | Germany | 15562 | |
| 269 | Research Site | Rülzheim | Germany | 76761 | |
| 270 | Research site | Schlüchtern | Germany | 36381 | |
| 271 | Research site | Schorndorf | Germany | 73614 | |
| 272 | Research site | Schwaebisch | Germany | 74523 | |
| 273 | Research site | Siegen | Germany | 57076 | |
| 274 | Research site | Sinsheim | Germany | 74889 | |
| 275 | Research site | Stade | Germany | 21682 | |
| 276 | Research site | Stadtroda | Germany | 07646 | |
| 277 | Research site | Stuttgart | Germany | 70176 | |
| 278 | Research site | Stuttgart | Germany | 70182 | |
| 279 | Research site | Teupitz | Germany | 15755 | |
| 280 | Research site | Trier | Germany | 54282 | |
| 281 | Research site | Troisdorf | Germany | 53844 | |
| 282 | Research site | Ulm | Germany | 89073 | |
| 283 | Research site | Ulm | Germany | 89077 | |
| 284 | Research site | Ulm | Germany | 89081 | |
| 285 | Research site | Unterhaching | Germany | 82008 | |
| 286 | Research site | Wasserburg | Germany | 83512 | |
| 287 | Research site | Weimar | Germany | 99425 | |
| 288 | Research site | Weinheim | Germany | 69469 | |
| 289 | Research site | Wermsdorf | Germany | 04779 | |
| 290 | Research site | Wernigerode | Germany | 38855 | |
| 291 | Research site | Wiesbaden | Germany | 65185 | |
| 292 | Research site | Wolfenbüttel | Germany | 38300 | |
| 293 | Research site | Wolfratshausen | Germany | 82515 | |
| 294 | Research site | Würzburg | Germany | 97080 | |
| 295 | Research site | Zwickau | Germany | 08058 | |
| 296 | Research site | Heraklion | Crete | Greece | 71201 |
| 297 | Research Site | Alexandroupoli | Greece | 68100 | |
| 298 | Research site | Athens | Greece | 10676 | |
| 299 | Research site | Athens | Greece | 11521 | |
| 300 | Research site | Athens | Greece | 11524 | |
| 301 | Research site | Athens | Greece | 11525 | |
| 302 | Research site | Athens | Greece | 11526 | |
| 303 | Research site | Ioannina | Greece | 45500 | |
| 304 | Research site | Patras | Greece | 26504 | |
| 305 | Research site | Patras | Greece | 26535 | |
| 306 | Research site | Thessaloniki | Greece | 54636 | |
| 307 | Research site | Thessaloniki | Greece | 56429 | |
| 308 | Research site | Thessaloniki | Greece | 57010 | |
| 309 | Research site | Bari | Italy | 70121 | |
| 310 | Research site | Bergamo | Italy | 24126 | |
| 311 | Research site | Cagliari | Italy | 09100 | |
| 312 | Research site | Cefalù | Italy | 90015 | |
| 313 | Research site | Chieti | Italy | 66013 | |
| 314 | Research site | Cuneo | Italy | 11100 | |
| 315 | Research site | Fidenza | Italy | 43036 | |
| 316 | Research site | Firenze | Italy | 50134 | |
| 317 | Research site | Foggia | Italy | 71100 | |
| 318 | Research site | Gallarate | Italy | 21013 | |
| 319 | Research site | Milano | Italy | 20122 | |
| 320 | Research site | Milano | Italy | 20133 | |
| 321 | Research site | Napoli | Italy | 80131 | |
| 322 | Research site | Orbassano | Italy | 10043 | |
| 323 | Research site | Roma | Italy | 00144 | |
| 324 | Research site | Roma | Italy | 00152 | |
| 325 | Research site | Roma | Italy | 00185 | |
| 326 | Research site | Zapopan | Jalisco | Mexico | 45150 |
| 327 | Research site | Monterrey | Nuevo León | Mexico | 64060 |
| 328 | Research site | Monterrey | Nuevo León | Mexico | 64380 |
| 329 | Research site | Aguascalientes | Mexico | 20230 | |
| 330 | Research site | Estado de México | Mexico | 52763 | |
| 331 | Research Site | Leon | Mexico | 37150 | |
| 332 | Research site | Mexico City | Mexico | 01030 | |
| 333 | Research site | Mexico City | Mexico | 05300 | |
| 334 | Research site | Mexico City | Mexico | 06700 | |
| 335 | Research site | Mexico City | Mexico | 06760 | |
| 336 | Research site | Mexico City | Mexico | 09220 | |
| 337 | Research Site | Mexico city | Mexico | 14260 | |
| 338 | Research site | Puebla | Mexico | 72540 | |
| 339 | Research Site | Puebla | Mexico | 91919 | |
| 340 | Research Site | San Luis Potosi | Mexico | 78399 | |
| 341 | Research Site | Almelo | Netherlands | 7600 SZ | |
| 342 | Research site | Blaricum | Netherlands | 1261 AN | |
| 343 | Research site | Breda | Netherlands | 4818 CK | |
| 344 | Research site | Den Haag | Netherlands | 2566 MJ | |
| 345 | Research site | Eindhoven | Netherlands | 5602 ZA | |
| 346 | Research site | Geldrop | Netherlands | 5664 EH | |
| 347 | Research site | Gouda | Netherlands | 2803 HH | |
| 348 | Research site | Heerenveen | Netherlands | 8441 PW | |
| 349 | Research site | Heerlen | Netherlands | 6419 PC | |
| 350 | Research site | Helmond | Netherlands | 5700 AB | |
| 351 | Research site | Hengelo | Netherlands | 7550 AM | |
| 352 | Research site | Hoorn | Netherlands | 1624 NP | |
| 353 | Research site | Leeuwarden | Netherlands | 8934 AD | |
| 354 | Research Site | Meppel | Netherlands | 7943 SM | |
| 355 | Research site | Nieuwegein | Netherlands | 3430 EM | |
| 356 | Research site | Nijmegen | Netherlands | 6500 GS | |
| 357 | Research site | Roermond | Netherlands | 6043 CV | |
| 358 | Research site | Rotterdam | Netherlands | 3079 DZ | |
| 359 | Research site | s Hertogenbosch | Netherlands | 5223 GZ | |
| 360 | Research site | Sittard-Geleen | Netherlands | 6162 BG | |
| 361 | Research site | Tilburg | Netherlands | 5022 GC | |
| 362 | Research site | Venray | Netherlands | 5801 CE | |
| 363 | Research site | Woerden | Netherlands | 3447 GN | |
| 364 | Research Site | Zwolle | Netherlands | 8011 JW | |
| 365 | Research site | Bergen | Norway | 5021 | |
| 366 | Research site | Bodo | Norway | 8092 | |
| 367 | Research site | Drammen | Norway | 3004 | |
| 368 | Research site | Forde | Norway | 6812 | |
| 369 | Research Site | Fredrikstad | Norway | 1603 | |
| 370 | Research site | Haugesund | Norway | 5504 | |
| 371 | Research site | Lillehammer | Norway | 2629 | |
| 372 | Research site | Lørenskog | Norway | 1478 | |
| 373 | Research site | Molde | Norway | 6407 | |
| 374 | Research site | Namsos | Norway | 7800 | |
| 375 | Research site | Oslo | Norway | 0027 | |
| 376 | Research Site | Oslo | Norway | 0407 | |
| 377 | Research Site | Skien | Norway | 3710 | |
| 378 | Research site | Stavanger | Norway | 4095 | |
| 379 | Research Site | Tromso | Norway | 9038 | |
| 380 | Research site | Trondheim | Norway | 7006 | |
| 381 | Research site | Tønsberg | Norway | 3103 | |
| 382 | Research site | Aveiro | Portugal | 3810-095 | |
| 383 | Research site | Beja | Portugal | 7801-849 | |
| 384 | Research site | Evora | Portugal | 7000-811 | |
| 385 | Research site | Funchal | Portugal | 9000 | |
| 386 | Research site | Lisboa | Portugal | 1349-019 | |
| 387 | Research site | Lisboa | Portugal | 1649-035 | |
| 388 | Research site | Porto | Portugal | 4200 - 319 | |
| 389 | Research site | Setubal | Portugal | 2910-446 | |
| 390 | Research Site | Banská Bystrica | Slovakia | 975 17 | |
| 391 | Research Site | Bratislava | Slovakia | 813 69 | |
| 392 | Research Site | Bratislava | Slovakia | 826 06 | |
| 393 | Research site | Bratislava | Slovakia | 833 05 | |
| 394 | Research site | Kosice | Slovakia | 041 66 | |
| 395 | Research site | Nitra | Slovakia | 949 01 | |
| 396 | Research site | Avila | Spain | 05071 | |
| 397 | Research site | Badalona | Spain | 08916 | |
| 398 | Research site | Barcelona | Spain | 08003 | |
| 399 | Research site | Barcelona | Spain | 08907 | |
| 400 | Research site | Girona | Spain | 17007 | |
| 401 | Research site | Langreo | Spain | 33920 | |
| 402 | Research site | Logroño | Spain | 26006 | |
| 403 | Research site | Palma de Mallorca | Spain | 07014 | |
| 404 | Research site | Ponferrada | Spain | 24411 | |
| 405 | Research site | San Sebastian | Spain | 20014 | |
| 406 | Research site | Tarragona | Spain | 43003 | |
| 407 | Research site | Tarragona | Spain | 43500 | |
| 408 | Research site | Vitoria | Spain | 01009 | |
| 409 | Research site | Edgbaston | Birmingham | United Kingdom | B15 2TH |
| 410 | Research site | Canterbury | Kent | United Kingdom | CT1 3NG |
| 411 | Research site | Hammersmith | London | United Kingdom | W6 8RF |
| 412 | Research site | Salford | Manchester | United Kingdom | M6 8HD |
| 413 | Research site | Belfast | United Kingdom | BT16 1RH | |
| 414 | Research site | Brighton | United Kingdom | BN2 5BE | |
| 415 | Research site | Bristol | United Kingdom | BS16 1LE | |
| 416 | Research site | Coventry | United Kingdom | CV2 2DX | |
| 417 | Research site | Exeter | United Kingdom | EX25DW | |
| 418 | Research site | Liverpool | United Kingdom | L9 7LJ | |
| 419 | Research site | Middlesborough | United Kingdom | TS4 3BW | |
| 420 | Research site | Newcastle Upon Tyne | United Kingdom | NE1 4LP | |
| 421 | Research site | Nottingham | United Kingdom | NG7 2UH | |
| 422 | Research site | Stoke on Trent | United Kingdom | ST4 6QG |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT00493298
Other Study ID Numbers:
- IMA-06-02
First Posted:
Jun 28, 2007
Last Update Posted:
Feb 8, 2021
Last Verified:
Feb 1, 2021
Keywords provided by Biogen
Additional relevant MeSH terms: