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CRAFT Trial

CRAFT
Count relapses after finishing the GAMPP trial

OFFICIAL TITLE.

A retrospective collection of clinical data concerning relapses in the period between month 6 andmonth 12 post partum in Multiple Sclerosis patients that have completed the GAMPP study.

STATUS. Organized by and under the direction of the European Charcot Foundation.

SPONSOR. None.

STUDY MEDICATION OF GAMPP STUDY. IVIG (5G/100ML) prepared for intravenous administration (Octagam© 5%, Octapharma Pharmazeutika Prod. Ges.m.b.H., Vienna, Austria)

GROUPS OF PATIENTS.


NUMBER OF CENTERS. 33.

NUMBER OF PATIENTS. 163.

PRINCIPAL INVESTIGATOR. Prof. O.R. Hommes

STEERING COMMITTEE.
Prof. J. Haas, Prof. O.R. Hommes, Ms. M. Friedrichs.

STUDY DURATION. 6 months.

ENDPOINTS.
Primary endpoint.
Frequency and severity of relapses in 6 months following the end of IVIG treatment.

Secondary endpoints.
Treatments in this period and co-medication
- relapse frequency in first and in second trimester
- breastfeeding
- EDSS