Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Not applicable
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/study/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/study/NCT00493116