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

Biogen

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: low immunogenic interferon-beta-1a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00493077

SAFE

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

1

Experimental group

Treatment:

Drug: low immunogenic interferon-beta-1a