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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00493077
First received: June 25, 2007
Last updated: January 28, 2008
Last verified: January 2008
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: low immunogenic interferon-beta-1a
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • neutralizing antibody levels will be followed [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients with NAb positive titre > 20. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Relative change from baseline (screening) of NAb titre [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: May 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: low immunogenic interferon-beta-1a
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493077

Locations
Sweden
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
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Investigator neurologyclinicaltrials@biogenidec.com
  More Information

No publications provided

Responsible Party: biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00493077     History of Changes
Other Study ID Numbers: SAFE
Study First Received: June 25, 2007
Last Updated: January 28, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by Biogen Idec:
Multiple Sclerosis
Neutralizing antibodies
Safety
Low immunogenicity
interferon
interferon-beta-1a

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Interferons
Interferon-beta
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 16, 2014