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ESIMS Trial
OFFICIAL TITLE.
European Multicentre randomised placebo-controlled double blind study to evaluate the efficacy and safety of intravenous Immune Globulin (IVIG) in patients with Secondary Progressive Multiple Sclerosis.
STATUS. Under the auspices of the European Charcot Foundation. Protocol and statistic handling FDA approved.
SPONSOR. Bayer (Bay 10-5230/8103).
TEST DRUG. Immune Globulin intravenous 10% SD.
NUMBER OF CENTERS. 31 in Europe and Canada.
NUMBER OF PATIENTS RECRUITED. 318.
PRINCIPAL INVESTIGATOR. Prof. O.R. Hommes
STEERING COMMITTEE.
Prof. O.R. Hommes (chair), Prof. L. Blumhardt, Prof. F. Fazekas, Dr. O. Fernandez, Prof. H. Kölmel, Prof. C. Pozzilli, Dr. P. O’Connor, Prof. P. Soelberg Sřrensen.
STUDY DURATION. 2 years.
MEDICATION. 1 gr/kg bodyweight 1 x per 30 days i.v.
END-POINTS.
Primary efficacy parameter.
Time to start of a confirmed treatment failure defined as a deterioration of 1 EDSS point of initial EDSS < 6.0 or of 0.5 EDSS point of initial EDSS > 6.0 at two time points (3 months interval ± 2 weeks) within the study period.
Secondary endpoints.
- Relapse rate.
- Change in lesion volume in T2.
ADDITIONAL PROTOCOLS.
- Magnetisation transfer.
- Brain atrophy.
- Cellular immunology.
- Evoked potentials.
END CLINICAL PHASE. February 2001.
CLOSURE DATABASE. July 2001.
RESULTS PUBLISHED.
'Intravenous immunoglobulin in secondary progressive Multiple Sclerosis: randomised placebo-controlled trial'. O.R. Hommes, P. Soelberg Sřrensen, F. Fazekas, M. Maas Enriquez, H. Kölmel, O. Fernandez, C. Pozzilli, P. O'Connor, for the European Study on Immunoglobulin in Multiple Sclerosis trialists. Lancet; 364: 1149 - 1156. |
