Human recombinant interferon beta in the treatment of relapsing-remitting multiple sclerosis: preliminary observations.
An open comparative, randomized trial with recombinant human interferon beta (r-hIFN-beta) involving 72 patients with clinically definite and/or laboratory-supported relapsing-remitting MS is in progress at the University 'La Sapienza' and at the S. Camillo Hospital of Rome. After a 6 month period of clinical and magnetic resonance imaging (MRI) observation (baseline findings), patients are randomly assigned to one of two treatment groups receiving 3 or 9 MIU of recombinant human IFN-beta (r-hIFN-beta) self-administered by subcutaneous injection three times a week for 6 months. All patients are examined by MRI with and without gadolinium (Gd-DTPA) every 4 weeks for the entire duration of the study (12 months). The main aim of the study is to test the hypothesis that r-hIFN-beta may halt or slow the progression of the disease by showing a significant reduction in MRI activity. This will be achieved by comparing pre and post-treatment periods. As an additional clinical end point, the exacerbation rate during these two periods will be compared. This study began in June 1993 and the final analysis of MRI data is planned for the spring of 1995.
Fieschi
C
C
Department of Neurological Science, University of Rome, La Sapienza, Italy.
Pozzilli
C
C
Bastianello
S
S
Koudriavtseva
T
T
Gasperini
C
C
Bozzao
A
A
Galgani
S
S
Paolillo
A
A
Millefiorini
E
E
Buttinelli
C
C
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000628:therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012008:Recurrence
D000276:Adjuvants, Immunologic; D011994:Recombinant Proteins; D016899:Interferon-beta