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ORIGIMS Trial
OFFICIAL TITLE.
A randomised, parallel group, placebo-controlled, double-blind phase III study of interferon beta-1a in the treatment of relapsing-remitting multiple sclerosis. (Original Interferon beta-1a in MS).
STATUS. Under the direction of the European Charcot Foundation.
SPONSOR. BioPartners GmbH.
TEST DRUG. Interferon beta-1a.
GROUPS OF PATIENTS.
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Group I |
Active drug, 104 weeks. |
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Group II |
Placebo, 104 weeks. |
NUMBER OF CENTERS. 17.
NUMBER OF PATIENTS. 356.
STEERING COMMITTEE.
Prof. F. Barkhof, Prof. L. Durelli, Dr. O. Fernandez, Prof. J. Haas, Prof. O.R. Hommes (chair), Dr. J. Palace, Prof. K. Selmaj, Dr. B. Uitdehaag.
STUDY DURATION. 24 months.
END-POINTS.
Primary outcome measure.
Mean number of exacerbations per patient over the study period.
Secondary outcome measure.
MRI, exacerbations, disability, quality of life, neutralising antibodies, compliance.
END OF STUDY. Spring 2006. |