The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
250 micrograms every other day, subcutaneously for 104 weeks
2x250 micrograms every other day, subcutaneously for 104 weeks
Unnamed facility
Ask Contact, Denmark
Unnamed facility
Copenhagen, Denmark
Unnamed facility
Hillerød, Denmark
Unnamed facility
Holstebro, Denmark
Unnamed facility
Magnetic Resonance Imaging (MRI): T2-lesions
Time frame: At week 104
Further Magnetic Resonance Imaging (MRI) parameters
Time frame: At week 104
Relapses
Time frame: At week 104
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
Time frame: At week 104
Hospitalizations
Time frame: At week 104
Neutralizing antibodies
Time frame: At week 104
Adverse events
Time frame: At week 104
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stockholm, Sweden
Unnamed facility
Stockholm, Sweden
Unnamed facility
Stockholm, Sweden