relapsing multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Trade Name: Betaferon 250µg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Interferon beta-1b
CAS Number: L03 A
Sponsors
Schering AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completion of the BEYOND study 306440 as scheduled (i.e. no premature EOS in study 306440) 2. Relapsing multiple sclerosis (i.e. including SPMS with superimposed relapses) 3. Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction. 4. Females of child-bearing potential: - Agreement to practice adequate contraception methods (intra-uterine contraceptive device [IUCD], condoms, oral contraceptives, or other adequate barrier contraception) and - Negative pregnancy test (urine test and blood sampling for serum test at first visit) and - No lactation 5. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Serious or acute heart diseases such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure 2. History of severe depression or suicide attempt, or current suicidal ideation 3. Epilepsy not adequately controlled by treatment 4. Known allergy to IFNs, to human albumin or to mannitol 5. The following pre-treatments within the specified time frames prior to study enrolment: • 6 months before study entry: - Natalizumab (Tysabri) • 3 months before study entry: - Any other monoclonal antibody treatment - Azathioprine - Cyclophosphamide - Cyclosporine A - Cladribine - Mitoxantrone - Any other immuno-modulating or immuno-suppressive drugs including other recombinant or non-recombinant cytokines Exceptions: IFNB 1b, glatarimer acetate, systemic corticosteroids, or ACTH - Any other treatment known to be used for putative or experimental MS treatment (exceptions: statins for treatment of hypercholesterinemia or pentoxifylline). 6. Current or past (within the last 2 years) alcohol or drug abuse 7. Inability to administer subcutaneous injections either by self or by caregiver 8. Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To increase the knowledge on the safety and tolerability profile of the IFNB-1b 500 µg dose ;Secondary Objective: To increase the knowledge on neutralizing activity to IFNB 1b and on patient-reported outcomes (PRO); Primary end point(s): The primary variables are the frequencies of the following events: 1. Flu-like-syndrome This variable will consist of a combination of MedDRA terms indicative for this condition. 2. Injection site reactions This variable will consist of a combination of MedDRA terms indicative for this condition. 3. Liver enzyme elevations This variable will include all patients with an elevation of either AST/SGOT, or of ALT/SGPT, or of gammaGT, using the respective laboratory's upper limits of normal. 4. Hematological abnormalities This variable will include all patients with decreased counts of white blood cells, platelets, neutrophil granulocytes, or lymphocytes, or a decreased hemoglobulin level, according to the respective laboratory's lower limits of normal. | — |
Countries
Austria, Belgium, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Slovenia, Spain, Sweden
Outcome results
None listed