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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

low immunogenic interferon-beta-1a

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Neutralizing antibodies, Safety, Low immunogenicity, interferon, interferon-beta-1a

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Research Site
Coordinating Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

neutralizing antibody levels will be followed

Secondary Outcome Measures

Proportion of patients with NAb positive titre > 20.

Relative change from baseline (screening) of NAb titre

Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients

The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.

Full Information

NCT ID

NCT00493077

First Posted

June 25, 2007

Last Updated

January 28, 2008

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00493077

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis, Neutralizing antibodies, Safety, Low immunogenicity, interferon, interferon-beta-1a

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

low immunogenic interferon-beta-1a

Other Intervention Name(s)

Avonex

Intervention Description

dosage and frequency as per Biogen Idec protocol

Primary Outcome Measure Information:

Title

neutralizing antibody levels will be followed

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Proportion of patients with NAb positive titre > 20.

Time Frame

12 months

Title

Relative change from baseline (screening) of NAb titre

Time Frame

12 months

Title

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

Title

The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Biogen-Idec Investigator

Organizational Affiliation

neurologyclinicaltrials@biogenidec.com

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Goteborg

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

Coordinating Research Site

City

Huddinge

Country

Sweden

Facility Name

Research Site

City

Joenkoeping

ZIP/Postal Code

551 85

Country

Sweden

Facility Name

Research Site

City

Karlstad

ZIP/Postal Code

651 85

Country

Sweden

Facility Name

Research Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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