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

January 28, 2008 updated by: Biogen

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteborg, Sweden, 416 85
        • Research Site
      • Huddinge, Sweden
        • Coordinating Research Site
      • Joenkoeping, Sweden, 551 85
        • Research Site
      • Karlstad, Sweden, 651 85
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: low immunogenic interferon-beta-1a
dosage and frequency as per Biogen Idec protocol
Other Names:
  • Avonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neutralizing antibody levels will be followed
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with NAb positive titre > 20.
Time Frame: 12 months
12 months
Relative change from baseline (screening) of NAb titre
Time Frame: 12 months
12 months
Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients
Time Frame: 12 months and as needed for relapses
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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Principal Investigator: Biogen-Idec Investigator, neurologyclinicaltrials@biogenidec.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2008

Last Update Submitted That Met QC Criteria

January 28, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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