Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000657628
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
18/10/2005
Date last updated
18/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multi-Centre, Open label Study to Investigate the Recovery of Interferon-b Efficacy in Relapsing-Remitting Multiple Sclerosis Patients with Neutralising IFN-b Antibodies and Reduced Bioavailability.
Scientific title
A Multi-Centre, Open label Study to Investigate the Recovery of Interferon-b Efficacy in Relapsing-Remitting Multiple Sclerosis Patients with Neutralising IFN-b Antibodies and Reduced Bioavailability.
Universal Trial Number (UTN)
Trial acronym
RENeu
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-remitting Multiple Sclerosis 790 0
Condition category
Condition code
Neurological 865 865 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive methylprednisolone 500mg oral daily for 3 consecutive days every month followed by AVONEX 30mcg IM weekly once the subject reverts to neutralising antibody negative status.
Intervention code [1] 560 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1109 0
Return of bioavailability of AVONEX® (Interferon b-1a) as measured by induction of MxA mRNA.
Timepoint [1] 1109 0
Secondary outcome [1] 2049 0
Effects and safety of a washout period with monthly methylprednisolone followed by challenge with AVONEX® on: Proportion of patients becoming neutralising antibody negative.
Timepoint [1] 2049 0
Secondary outcome [2] 2050 0
Proportion of patients relapse free.
Timepoint [2] 2050 0
At 6, 12, 18 and 24 months.
Secondary outcome [3] 2051 0
Total relapses
Timepoint [3] 2051 0
At 27 months.
Secondary outcome [4] 2052 0
Proportion of patients with increase in Expanded Disability Status Scale (EDSS).
Timepoint [4] 2052 0
Secondary outcome [5] 2053 0
Brain atrophy (BPF) measured on MRI
Timepoint [5] 2053 0
Secondary outcome [6] 2054 0
Cumulative number of new or enlarging T2 lesions; T2 lesions volume; T1 lesions volume.
Timepoint [6] 2054 0
Secondary outcome [7] 2055 0
Number and volume of enhancing lesions.
Timepoint [7] 2055 0
Secondary outcome [8] 2056 0
Quality of life assessment as measured on visual analogue scale (VAS).
Timepoint [8] 2056 0

Eligibility
Key inclusion criteria
Diagnosis of relapsing-remitting multiple sclerosis; treated with interferon-b; EDSS below 6.0; test positive for NABs (at least 20 via CPE assay or at least 100 via MxA protein assay) on two consecutive tests at least 3 months apart; reduced bioavailability as measured by MxA mRNA/GAPDH.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 954 0
Commercial sector/Industry
Name [1] 954 0
Biogen Idec Australia Pty Ltd
Country [1] 954 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Biogen Idec Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 822 0
None
Name [1] 822 0
N/A
Address [1] 822 0
Country [1] 822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2250 0
Department of Neurology, Liverpool Hospital
Ethics committee address [1] 2250 0
Ethics committee country [1] 2250 0
Australia
Date submitted for ethics approval [1] 2250 0
Approval date [1] 2250 0
Ethics approval number [1] 2250 0
Ethics committee name [2] 2251 0
Dept. of Neurosciences, Box Hill Hospital
Ethics committee address [2] 2251 0
Ethics committee country [2] 2251 0
Australia
Date submitted for ethics approval [2] 2251 0
Approval date [2] 2251 0
Ethics approval number [2] 2251 0
Ethics committee name [3] 2252 0
Department of Neurosciences, St Vincent's Hospital
Ethics committee address [3] 2252 0
Ethics committee country [3] 2252 0
Australia
Date submitted for ethics approval [3] 2252 0
Approval date [3] 2252 0
Ethics approval number [3] 2252 0
Ethics committee name [4] 2253 0
Dept of Neurology, Launceston General Hospital
Ethics committee address [4] 2253 0
Ethics committee country [4] 2253 0
Australia
Date submitted for ethics approval [4] 2253 0
Approval date [4] 2253 0
Ethics approval number [4] 2253 0
Ethics committee name [5] 2254 0
Dept of Neurology, Queen Elizabeth Hospital
Ethics committee address [5] 2254 0
Ethics committee country [5] 2254 0
Australia
Date submitted for ethics approval [5] 2254 0
Approval date [5] 2254 0
Ethics approval number [5] 2254 0

Summary
Brief summary
Patients taking beta interferon therapy for multiple sclerosis may develop antibodies to the therapy, called neutralising antibodies. These antibodies can block the action of interferon, reducing its bio-availability for use in the body, thereby reducing its effectiveness as a treatment. This study explores one possible way of reducing the levels of neutralising antibodies in the system by suspending interferon treatment, treating the patient with methylprednisolone to reduce the antibody levels, then restarting interferon therapy by giving AVONEX injections once weekly, and testing to see if the bio-availability or 'effectiveness' of the interferon therapy is restored.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35732 0
Address 35732 0
Country 35732 0
Phone 35732 0
Fax 35732 0
Email 35732 0
Contact person for public queries
Name 9749 0
Aaron Tabensky
Address 9749 0
Biogen Idec Australia Pty Ltd
PO Box 380
North Ryde BC NSW 1670
Country 9749 0
Australia
Phone 9749 0
+61 414297954
Fax 9749 0
Email 9749 0
Aaron.Tabensky@biogenidec.com
Contact person for scientific queries
Name 677 0
Aaron Tabensky
Address 677 0
Biogen Idec Australia Pty Ltd
PO Box 380
North Ryde BC NSW 1670
Country 677 0
Australia
Phone 677 0
+61 414297954
Fax 677 0
Email 677 0
Aaron.Tabensky@biogenidec.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.