Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy

Study Overview
=================
Brief Summary
-----------------
This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

Detailed Description
-----------------
This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.

Official Title
-----------------
A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: low immunogenic interferon-beta-1a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing-remitting MS according to Poser criteria(CDMS or LSDMS)30 or MS according to McDonald criteria Disability equivalent to an EDSS of 6.0 or less at screening Neutralizing antibody titre > 20 and <500 in two consecutive NAb tests. One must be from before screening previous treatment with either subcutaneous administered interferon-b-1b (Betaferon®) or interferon-b-1a (Rebif TM) prior to enrolment A priori has been decided to be treated with AVONEX Exclusion Criteria: Is NAb positive on AVONEX History of major depression Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV), or significant hypertension (BP > 180/110 mmHg) Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: low immunogenic interferon-beta-1a<br>* dosage and frequency as per Biogen Idec protocol<br>* Other names: Avonex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neutralizing antibody levels will be followed |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with NAb positive titre > 20. |  | 12 months | 
| Relative change from baseline (screening) of NAb titre |  | 12 months | 
| Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients |  | 12 months and as needed for relapses | 
| The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Neutralizing antibodies, Safety, Low immunogenicity, interferon, interferon-beta-1a