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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00493116




Registration number
NCT00493116
Ethics application status
Date submitted
25/06/2007
Date registered
27/06/2007
Date last updated
16/09/2013

Titles & IDs
Public title
Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
Scientific 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
Secondary ID [1] 0 0
AUS-8001
Universal Trial Number (UTN)
Trial acronym
RENeu
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon-beta-1a
Treatment: Drugs - methylprednisolone

Experimental: 1 -


Treatment: Drugs: Interferon-beta-1a
dosage and frequency as per Biogen Idec protocol

Treatment: Drugs: methylprednisolone
dosage and frequency as per Biogen Idec protocol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNA
Timepoint [1] 0 0
screening and every 3 months from month 6 to month 27
Secondary outcome [1] 0 0
Proportion of patients becoming neutralizing antibody negative
Timepoint [1] 0 0
screening and every 3 months from month 3 to month 27
Secondary outcome [2] 0 0
proportion of patients becoming neutralizing antibody positive after treatment with AVONEX
Timepoint [2] 0 0
at baseline and every three months
Secondary outcome [3] 0 0
proportion of patents relapse free
Timepoint [3] 0 0
months 6, 12, 18 and 24
Secondary outcome [4] 0 0
total relapses
Timepoint [4] 0 0
27 months
Secondary outcome [5] 0 0
proportion of patients with an increase in EDSS of 1 point
Timepoint [5] 0 0
screening, 3, 9, 15, 21, and 27 months
Secondary outcome [6] 0 0
Brain atrophy and cumulative number of enlarging T2 lesions on MRI
Timepoint [6] 0 0
months 0, 12, and 27

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Coordinating Research Site - NSW
Recruitment postcode(s) [1] 0 0
- NSW
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00493116
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00493116