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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493077
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : January 30, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: low immunogenic interferon-beta-1a Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: low immunogenic interferon-beta-1a
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex

Primary Outcome Measures :
  1. neutralizing antibody levels will be followed [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Proportion of patients with NAb positive titre > 20. [ Time Frame: 12 months ]
  2. Relative change from baseline (screening) of NAb titre [ Time Frame: 12 months ]
  3. 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 ]
  4. The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS. [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493077

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Research Site
Goteborg, Sweden, 416 85
Coordinating Research Site
Huddinge, Sweden
Research Site
Joenkoeping, Sweden, 551 85
Research Site
Karlstad, Sweden, 651 85
Research Site
Stockholm, Sweden, 141 86
Sponsors and Collaborators
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Principal Investigator: Biogen-Idec Investigator
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Responsible Party: biogen Idec MD, Biogen Idec Identifier: NCT00493077    
Other Study ID Numbers: SAFE
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008
Keywords provided by Biogen:
Multiple Sclerosis
Neutralizing antibodies
Low immunogenicity
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic