eutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF

Conditions: 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: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

Registration Number: EUCTR2008-008554-23-SE

Lead Sponsor: The Multiple Sclerosis Research Group, Department of Clinical Neuroscience

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>•Frequency of high titer neutralizing antibodies after 2 years of (PPT) treatment in interferon beta naïve patients initiated on RNF<br><br>

Secondary Outcome Measures