Clinical Trial Results:
Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.
A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.
Summary
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EudraCT number |
2007-003936-50 |
Trial protocol |
ES FR NL BE SE AT CZ LT GB |
Global completion date |
30 May 2011
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jun 2016
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First version publication date |
29 Jun 2016
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Other versions |
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Summary report(s) |
2007-003936-50_CT.gov results |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.