IFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation). MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Trade Name: Rebif
Product Name: Rebif
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON BETA-1A
CAS Number: 145258-61-3
Concentration unit: µg microgram(s)
Concentration type
Sponsors
The Multiple Sclerosis Research Group, Department of Clinical Neuroscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. IFNß naïve MS patients with RRMS. 2. 18-60 years old. 3. Patients who have agreed to initiate treatment with RNF 4. Patients who have given signed consent to participate in the study. 5. Women shall not be pregnant and shall not have the intention of becoming pregnant during the study. 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. Patients with a previous treatment history of IFNß or IFN?. 2. Patients with a positive NAb test before initiation of RNF. 3. Patients treated with glatiramer acetate, IVIG or natalizumab within the previous 3 months. 4. Patients treated with immunosuppressive treatments such as mitoxantrone, alemtuzumab or azathioprine during the previous 6 months. 5. Patients with relevant non-MS condition potentially complicating IFNß treatment. 6. Contraindication for interferon beta treatment as per SPC. 7. Women that becomes pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: Prospective assessment of NAb development in interferon beta naïve patients initiated on Rebif New Formulation;Secondary Objective: The secondary objective will be to compare CPE NAb titres vs. NAb titers obtained by another interferon beta NAb assay.;Primary end point(s): Primary endpoint: • Frequency of high titer neutralizing antibodies after 2 years of (PPT) treatment in interferon beta naïve patients initiated on RNF | — |
Countries
Sweden
Outcome results
None listed