ETOMS Trial

OFFICIAL TITLE.

A multicentre, randomised, double blind, placebo controlled, phase III study of subcutaneous REBIF (recombinant human interferon-beta) in the treatment of clinically probable or laboratory-supported definite multiple sclerosis (Early Treatment of MS, “ETOMS” study).

STATUS: Under the auspices of the European Charcot Foundation.

SPONSOR: Serono.

TEST DRUG: REBIF 22 μg.

GROUPS OF PATIENTS:154 interferon beta 1-a, 155 placebo.

NUMBER OF CENTERS: 57.

NUMBER OF PATIENTS: 309.

PRINICPAL INVESTIGATOR: Prof. G. Comi.

STEERING COMMITTEE:
G. Comi (chair), M. Filippi, F. Barkhof, L. Durelli, G. Edan, O. Fernandez, H.-P. Hartung, P. Seeldrayers, P. Soelberg Sørensen, M. Rovaris, V. Martinelli, O.R. Hommes.

STUDY DURATION. 2 years.

ENDPOINTS.

- Conversion to clinically definite MS.
- Annual relapse rate.
- Median number of lesions per MRI scan.
- T2 lesion volume.

RECRUITMENT: Between August 1995 and July 1997.

END OF STUDY: July 1999.

RESULTS PUBLISHED.