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Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta (RENeu)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Interferon-beta-1a

methylprednisolone

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring recovery of efficacy, MxA protein, neutralizing antibodies, Multiple sclerosis

Eligibility Criteria

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

Inclusion Criteria:

Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria
EDSS score of 6 or less
NAB titre >or equal to 20 via CPE assay or >or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
Reduced bioavailability (relative expression of MxA mRNA/GAPDH

Exclusion Criteria:

History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs
Clinically significant systemic illness
History of poorly controlled hypertension, diabetes, or osteoporosis
History of uncontrolled seizures within 3 months of enrollment
History of Depression or suicidal ideation within 3 months of enrollment
Serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study
abnormal screening blood tests

Sites / Locations

Coordinating Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA

Secondary Outcome Measures

Proportion of patients becoming neutralizing antibody negative

proportion of patients becoming neutralizing antibody positive after treatment with AVONEX

proportion of patents relapse free

total relapses

proportion of patients with an increase in EDSS of 1 point

Brain atrophy and cumulative number of enlarging T2 lesions on MRI

Full Information

NCT ID

NCT00493116

First Posted

June 25, 2007

Last Updated

September 12, 2013

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00493116

Brief Title

Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta

Acronym

RENeu

Official Title

A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta

Detailed Description

This is an explorative multi-centre, open label, non-comparative trial investigating whether it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple sclerosis patients with high titres of neutralizing IFN-beta antibodies. Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by the relative expression of MxA mRNA/GAPDH. Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for 3 days every month until they become Neutralizing Antibody negative. Subjects will then be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months to determine return of biological activity. Clinical and MRI parameters, safety and tolerability will be compared to baseline to determine efficacy.

6. Conditions and Keywords

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

Relapsing-Remitting Multiple Sclerosis

Keywords

recovery of efficacy, MxA protein, neutralizing antibodies, Multiple sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Interferon-beta-1a

Other Intervention Name(s)

Avonex

Intervention Description

dosage and frequency as per Biogen Idec protocol

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Intervention Description

dosage and frequency as per Biogen Idec protocol

Primary Outcome Measure Information:

Title

return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA

Time Frame

screening and every 3 months from month 6 to month 27

Secondary Outcome Measure Information:

Title

Proportion of patients becoming neutralizing antibody negative

Time Frame

screening and every 3 months from month 3 to month 27

Title

proportion of patients becoming neutralizing antibody positive after treatment with AVONEX

Time Frame

at baseline and every three months

Title

proportion of patents relapse free

Time Frame

months 6, 12, 18 and 24

Title

total relapses

Time Frame

27 months

Title

proportion of patients with an increase in EDSS of 1 point

Time Frame

screening, 3, 9, 15, 21, and 27 months

Title

Brain atrophy and cumulative number of enlarging T2 lesions on MRI

Time Frame

months 0, 12, and 27

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: Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria EDSS score of 6 or less NAB titre >or equal to 20 via CPE assay or >or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart Reduced bioavailability (relative expression of MxA mRNA/GAPDH Exclusion Criteria: History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs Clinically significant systemic illness History of poorly controlled hypertension, diabetes, or osteoporosis History of uncontrolled seizures within 3 months of enrollment History of Depression or suicidal ideation within 3 months of enrollment Serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study abnormal screening blood tests

Facility Information:

Facility Name

Coordinating Research Site

City

NSW

Country

Australia

Facility Name

Research Site

City

Hamilton

Country

New Zealand

12. IPD Sharing Statement

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Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta

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