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

Multiple Sclerosis Clinical Trial

— SAFE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493077
• Other study ID #: SAFE
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2007
• Last updated: January 28, 2008
• Start date: May 2004
• Est. completion date: May 2006

Study information

• Verified date: January 2008
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• low immunogenic interferon-beta-1a
dosage and frequency as per Biogen Idec protocol

Locations

Country	Name	City	State
Sweden	Research Site	Goteborg
Sweden	Coordinating Research Site	Huddinge
Sweden	Research Site	Joenkoeping
Sweden	Research Site	Karlstad
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neutralizing antibody levels will be followed		12 months	Yes
Secondary	Proportion of patients with NAb positive titre > 20.		12 months	Yes
Secondary	Relative change from baseline (screening) of NAb titre		12 months	Yes
Secondary	Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients		12 months and as needed for relapses	No
Secondary	The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.		12 months	No